In this position you will be responsible for managing a framework which allows you to control, administer and deploy many different packages to our Mac population.  You will be charged with managing our inventory/asset management system and responsible for local user policy enforcements, deploying packages, updates and applications, image creation and deployments.  You will be performing thorough internal testing, working with team members on quality assurance and distribute the software via System Casper to the production environment.  In addition to software packaging, this role requires a strong JSS Casper Suite software distribution foundation with the ideal candidate having experience in implementation of machine based distributions on a global scale.

• Defining desktop hardware standards and work with engineering to secure the standard corporate image.
• Implementation and design of software distribution through Jamf/Casper and support distribution points.
• Assist application owners with the planning for the certification and deployment of new or upgraded applications including assisting with the creation of install instructions and test scripts.
• Communicate and collaborate with other IT services providers especially in the supporting areas and project/portfolio managers and ensure that every affected group is communicated to and has signed-off on the stability and readiness of the application/software.
• Participate in all aspects of the application lifecycle for applications supported within the OSX workstation environment. This includes research, analysis, testing, certification, documentation and support. 
• Assist in providing 2nd and 3rd level support with any application issue once deployed.  
• Work with engineering to develop strategies for Genentech’s operations management.
• Work with engineering to design and deploy solutions to the desktop.
• Interact with vendors and functional teams in order to restore services and correct core problems. 
• Perform daily administration, configuration, application integration, functional specifications and development tasks for infrastructure technologies and services.
• Handles and tracks routine incidents and problems and develop support procedures, technical documentation and other related documentation 
• Develop best practices and deployment services for reuse across the enterprise.
• Monitor trends and use the information to suggest and develop continuous improvements to the operations of the solution.
• Work with engineering to document and optimize current infrastructure environment.
• Under limited supervision, responds to and diagnoses problems for enterprise-managed applications and systems and/or routine hardware, software, and network problems. 
• Ability to work in a virtual team atmosphere while being self-motivated with minimum direction in a fast paced environment; as an integral part of a virtual team, you will work closely with other Team members and supporting departments across the globe

It is expected and required that he/she has current knowledge of business processes and IT industry trends and developments.  He/she is expected to have excellent inter-personal and project management skills and team work experience with operations and support staff.  Have delivered and deployed a number of IT services, systems and components.  Additional experience and knowledge of Microsoft System Center Configuation Manager or JAMF Casper Suite and related infrastructure.

The person must have a minimum of 5 year’s experience working in a medium to large company performing infrastructure implementations and operations and excellent knowledge and experience working with information management disciplines such as: server, storage, security, integration and applications. 

Job Responsibilities:

Reporting to the manager of the Automation Systems group, the Systems Administrator is responsible for development and support of IT infrastructure and vendor application software associated with mission-critical automation systems, including the Building Automation System (BAS), Utilities Control System (UCS), Programmable Logic Controllers (PLCs), and Vendor Supplied Controllers (VSCs). Specific responsibilities will include:

• Perform GMP maintenance activities on automation systems, including monitoring, physical and logical security, backups, and change control
• Respond to system issues (including 24x7 on-call support); Troubleshoot and remediate issues
• Complete discrepancy, investigation and CAPA records as required
• Install operating system and vendor software patches and upgrades; Design and implement hardware upgrades, system expansions and enhancements
• Support site and network projects that involve system changes
• Perform periodic reviews and revalidations according to quality standards and validation protocols
• Assess and manage risks associated with system operation and use, and design and implement improvements
• Support site audits and inspections, and implement corrections as needed
• Maintain system documentation and life cycle support strategies
• Manage vendor support contracts to ensure delivery of products and services, and process renewals to ensure continuous coverage

System Specialist, gRED Desk-side Support

• The gRED Desk-Side Support Specialist supports multiple computing platforms such as Mac, Windows, Linux, and iOS in laboratory and desktop computing environments. 

• The successful candidate will also apply networking concepts, printer troubleshooting, hardware and software troubleshooting knowledge and data backup technology in day-to-day operations. 

• While working in a highly team-oriented environment, the gRED DSS Specialist will work to achieve defined metrics within the incident management and request fulfillment processes and also be a technical resource to junior team members. 

• The successful candidate would also have the potential to lead team efforts. 

Job Purpose:

The Team Lead for CSV auditors in PDQA is responsible for recruitment, management and leadership of department audit staff.  Through their leadership and direction, they ensure consistent implementation of PDQA processes and procedures and execution of the audit strategy related to Computer System Validation

Primary Responsibilities and Accountabilities:

• Provide leadership and direction to the PDQA CSV audit team in the execution of the department strategy
• Recruit, manage, train and develop staff
• Motivates and manages team members through setting of individual goals, provides on-going feedback and performance evaluations
• Oversee staff expenditures
• Collaborate with other Team Leaders to resource and manage the audit program in line with PDQA Strategy 
• Manage resources according to department strategy
• Review staff deliverables (audit plans, audit reports, quality plans, etc)
• May participate on audits as necessary (staff evaluations)

• Contribute to the development and execution of PDQA goals and initiatives
• Participate in or lead departmental or cross-functional compliance projects and initiatives as assigned
• Assists and/or contributes to the development and/or revision of PDQA SOPs, guidelines and tools

• Supports Head of CSV Strategy and TL, Validation Analysts to establish and implement global CSV strategy, goals and objectives for team
• Participates on IT/CSV projects and task forces to provide quality management oversight

• Ensure consistent execution of PDQA strategy, processes and procedures
• Oversee execution of department strategy, processes and procedures
• Provide CSV compliance advice to staff 
• Ensure audits are conducted and reported in compliance with departments procedures
• Support regulatory authority inspections
• Escalate compliance issues/risks to PDQA Management
• Maintain knowledge of HR Corporate policies and procedures
• Maintain knowledge of current regulatory, GCP, GLP, CSV and/or PV regulations and guidelines and company policies, SOPs and procedure

The QA Product Technical Manager is the key point of contact for all issues affecting the disposition of their assigned product(s). This individual will be responsible for interacting with multiple departments within Roche to assure that all lot disposition issues are identified and resolved within standard lead times.
• Perform assigned tasks and work to achieve company goals and department objectives.
Job Duties/Responsibilities:
• Follow company policies and procedures.
• Maintain a state of inspection readiness.
• Provide input to the development of personal performance goals and departmental objectives.
• Collaborate with Management to establish and meet targets and timelines.
• Support routine operations and allocate assigned resources.
• Manage competing priorities.
• Serve as the Quality representative on cross-functional and multi-site teams.
• Identify, design, and implement process and system improvements.
• Lead and participate in the design and implementation of department and cross-functional initiatives.
• Apply advanced theory, technical principles, and expert judgment to address a broad range of difficult problems.
• Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.
• Serve as a technical subject matter expert (SME) in support of department functions.
• Train personnel and internal customers on relevant business processes.
• Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions.
• Be accountable for behaviors as described in Genentech’s Core, Common, and Critical Competencies.
• Perform any other tasks as requested by Management to support Quality oversight activities.

Technical Duties/Responsibilities:
• Oversight of the activities associated with dispositioning of assigned production lots within established standard lead times.
• Management of lot disposition activities to ensure that products are dispositioned in accordance with regulatory requirements, cGMPs and Genentech policies and procedures, within established standard lead time.
• Interfacing with appropriate departments or manufacturing plants to ensure that lot disposition items are completed.
• Notification to Senior Management for all known delays in meeting established standard lead times or any potential significant quality issues.
• Interfacing with QA Lot Disposition Supervisors and Final Reviewers to ensure that final review activities are completed. Lead and provide guidance to Final Reviewers as required.
• Perform a review of investigations for potential cumulative effect to a batch history record.
• Perform a review of QC out of trend results for cumulative effect.
• Provide assistance to CMC teams by addressing lot disposition issues as they arise.
• Support regulatory inspections as needed.
• Assess batch history records as part of investigations into product complaints.
• Revise and approve applicable lot disposition documents as needed.

This is a term position for approximately 9 months

Responsible for implementing and maintaining the validated state of automated systems at Genentech’s Oceanside Facility. Expected to be knowledgeable of and work within GMP regulations.  Requires protocol generation, execution, data analysis, troubleshooting skills, deviation investigation and protocol report closure for the site.  Responsible for validation contractor oversight, demonstrating leadership skills and modeling Genentech values and core competencies while working closely with Engineering, MSAT, Quality Assurance and Manufacturing.  This position requires strong communication and collaboration skills, the ability to work within teams, facilitate meetings and lead teams.  

Job Responsibilities

Essential

Manage and track the Validation program and assigned validation projects for automated systems and ensure target timelines are met and/or issues are communicated / escalated effectively and consistently.
Generate, review, approve and maintain Qualification Project Plans and Summary Reports and other validation lifecycle documents for automated systems.
Generate, review and approve a variety of Validation protocols (IQs, OQs, IOQs, PQs) for automated systems.
Manage protocol execution, perform data review and manage deviation resolution.
Oversight and management of validation contract resources including work prioritization, execution and contractor budget.
Strong understanding of commercial production environment and requirements.
Evaluate and audit the current validated status of automated systems.  Make suggestions for improvements as well as ensure system is operating in compliance and validated state.
Present validation packages for automated systems as required for audits and/or regulatory inspections.
Perform role of subject matter expert and assess change control and discrepancy events for automation systems.
Review automation validation lifecycle documents for compliance with CFRs, corporate requirements, and site procedures.
Lead group of Subject Matter Experts through the Quality Risk Management process and prepare Risk Management Reports documenting system risks, applicable remediation/risk reduction and critical controls.
Participate in cross-functional team meetings and where required, lead/facilitate meeting.
Review validation lifecycle documents for compliance with CFRs, corporate policies (QP/QS documents), and site procedures (SOP’s).
Participate in cross-functional team meetings and where required, lead/facilitate meeting.
Ensures there will be integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within their functional area.

The Vice President and General Manager for our Vacaville site is responsible for ensuring the safe, efficient, cost-effective, compliant and quality manufacturing of Roche/Genentech commercial drug substance. The individual will oversee all site activities. The VP/GM is responsible for leading and overseeing the assigned plant's operations, management and staff, with direct and indirect reports of over 700+ employees, annual expense and capital budget management of $200+ million USD, with total annual product manufacturing responsibilities in the multi-billion potential product sales. The VP/GM is responsible for all plant operations: including staffing of the plant, manufacturing, engineering, validation, facilities, technology, warehousing, Environmental Health & Safety (EHS) and operational excellence. VP/GM is accountable for meeting the site’s production plans, on-time, on-target and within-budget, and in accordance with all safety, quality, compliance, regulatory, productivity and other performance metrics and targets. The Vice President is a member of the Biochemical Manufacturing Leadership Team; and as such, plays a key role in defining, setting and implementing the long range vision, strategy, objectives of the overall network.

The Vice President will collaborate with peer VP General Managers to create a supply network that:

-- Ensures nimble decision making

-- Enhances operational practice sharing and process governance

-- Facilitates bulk network optimization and workforce planning

-- Facilitates bulk capacity utilization and cost of clinical manufacturing

-- Creates a clear charter and performance measures

Responsibilities:

• Stays abreast of internal and external industry and marketplace dynamics and evolutions

• Acts as a standing member of the Biochemical Manufacturing Leadership Team

• Identifies industry or other marketplace trends and dynamics that potentially impact Roche and its production operations

• Makes important contributions to the annual, medium- and longer-range vision, strategy, objectives and plans for the Biologics network. Includes important contributions to PT's biochemical manufacturing network: network optimization, sharing best practices, lessons learned, leveraging innovations and resources, etc.

• Evaluates new products, new or updated production processes, systems, technologies, equipment or other business and operational strategies and plans for potential implications to Roche/Genentech's manufacturing plants and operations

• As part of the Biochemical Manufacturing Leadership Team, makes important contributions to the site 5-year plans and annual revisions/updates

• Plays a leadership role in PT's talent management review and planning processes

• Champions initiatives, best practices, continuous process improvement, compliance, quality and the like

• Acts as a lead business process owner for biochemical manufacturing core and sub-processes

• Job Family & Role-specific Responsibilities:  

• Drives and delivers business results across the assigned plant; focusing on manufacturing processes that improve reliability, increase simplicity, lower cost, and enable sustainable and scalable growth

• Works closely with partners in Quality & Compliance, Regulatory CMC & Information Systems, Global Supply Chain, and Corporate EHS to develop appropriate safety, compliance, quality, cost, productivity and other relevant policies, procedures, goals and metrics

• Accountable for ensuring the assigned plant consistently meets all cGMP (Current Good Manufacturing Practices) and other regulatory requirements

• Accountable to ensure, at all times, that the assigned plant is regulatory inspection-ready

• Defines, sets and oversees effective and efficient execution against the annual, medium- and long-range vision, strategy, objectives and plans for the assigned plant, its operations, projects, management and staff

• Works closely with Corporate Engineering to plan for and execute plant capital projects

• Responsible for ongoing development and improvement of the infrastructure necessary for the assigned plant to effectively and efficiently deliver against its vision, strategy, plans a...

Utilities Frontline group is looking for candidates in 2013 that wants real-world learning opportunity in the Pharmaceutical/Biotechnology Industry. The candidate’s responsibilities include assisting Utility Frontline (UFL) Automation Engineer in
 
1) Lean Six Sigma and other continuous improvement projects
2) Implementation plan and test protocol generations
3) Change implementation
4) Programming of PLC and HMI

Candidates should be comfortable with some repetitive administrative task. Candidate should also be able to follow appropriate SOPs and other written procedures and document all work with great attention to detail.  In return, candidate will acquire hands-on skills and knowledge of Automation, and Industrial Control Engineering used in the Pharmaceutical/Biotechnology Industry.

Job Responsibilities:

• Provide assistance to the AE with data collection for Lean Six Sigma project
• Provide assistance to the AE with the various duties on a day-to-day basis
• Provide administrative assistance to AE such as test protocol generation and change implementation documents development.
• Develop an understanding of Automation system and utilize the acquired skills to projects assigned.

Job Purpose:  

The Head, Safety Sciences, leads and directs one of the therapeutic areas of safety science aligned with the Oncology disease to provide strategic direction and standardization of performance across the Safety Science groups.  

The Head, Safety Sciences directs Product Development Safety's (PDS) disease area specific scientific analysis including medical evaluation, risk assessment and management, signal prediction/detection, Comparative Benefit Risk, using epidemiology and other input as appropriate.  

The Head, Safety Sciences will ensure the incorporation of Comparative Benefit-Risk concepts in the disease area strategy and product plans and their use throughout the development and commercial lifecycle of products assigned to the cluster to ensure their longevity. In general, he/she is a member of a Development Review Committee (DRC).

Primary Responsibilities:

• Ensure proactive surveillance and monitoring activities across theirsafety science cluster to ensure that Roche is aware of potential emergingsafety issues and has developed strategies & action plans to prevent &mitigate risks.

• Direct and manage the SSLs andtheir teams within the safety science therapeutic area and provide guidance tothe relevant development and safety committees as appropriate.

• Maintain managerial oversight ofissues and outputs from the therapeutic area Safety Teams address or elevateissues to the PDS Global Head, Drug Safety Committee, Lifecycle Teams, Research and Early Development teams, and various committees.

• Ensure the incorporation of ComparativeBenefit-Risk concepts & qualitative/quantitative methods in the DiseaseArea (in collaboration with Clinical, Regulatory & Medical Affairs) andtheir use throughout the development and commercial lifecycle to ensure thesafety and longevity of all products in their therapeutic area.

• Leadcontinuous improvement efforts in Safety Science capability and performancetogether with the other Heads of Safety Science areas. Provide leadership and linemanagement to their reports and other members of the Safety Sciences departmentacross multiple locations. 

• Build andleverage Roche and PDS’ influence with internal and external entities to createvalue for Roche.

• Ensure Collaborative and constructive business relationships with majorpartners where applicable (with particular interest in Chugai).  Ensure particular emphasis is placed oncommunication flow and inter company.

• Contributes as part of the Global Leadership Team to the overallmanagement of the Safety Risk Management Department.

• Partners with Clinical Development organization to facilitate and collaborate towards the development of new oncology products proactively. Build strategic relationships with Clinical Development Oncology to drive innovative trial designs and influence decision-making.