Director/Associate Director Compliance, Quality Systems, Validation

Hillsboro
Oregon, United States of America

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The Position

Purpose

  • Responsible for management of compliance activities in accordance with Roche policies, standards, procedures and Global cGMPs.
  • Lead Compliance, Quality System & Validation activities to drive maintenance and continuous improvement of an efficient Quality System to ensure Quality and Regulatory Compliance across the site.
  • Establish strategic goals and objectives and maintain full strategic responsibility for the Compliance, Quality Systems & Validation organization.
  • Implement, realize and monitor Quality System elements, including PQS, APQR, and Quality Systems Management Review, quality metrics, SMF, TCM, Quality Risk Management, and Document Management System.
  • Oversight of implementation and realization of Quality Validation activities including Process Validation, Cleaning Validation, CSV, QC Equipment Qualification, and Tech Transfer.
  • Functional responsibilities include hosting and management of regulatory inspections and corporate GMP audits, management of the internal inspection readiness program, management of emerging regulations and systematic evaluation of new requirements, oversight for trending of Quality Compliance Performance, supplier management and Regulatory liaison. 
  • The Quality Compliance leader is the single point of contact at the site for external health authority queries and internal business partners.

Key Responsibilities:

Leadership and People Management

  • Create an environment of strong team spirit, timely and effective communications, sense of urgency and high motivation, and inspire teams to achieve goals in the immediate and longer term.  Be an active and visible change agent, promoting flexible and open mindsets to new opportunities.
  • As a leader within Quality Site Leadership team, drive network activities and alignment, cross-functional planning, and decision making.
  • Accountable for overall budget and financial performance of the Compliance, Quality Systems and Validation function.
  • Engage in proactive measures to promote a positive safety culture while ensuring all applicable Safety, Health and
  • Environment requirements are fulfilled in alignment with corporate policy and local legal requirements.
  • Embody PT lean principles and methods while fostering a continuous improvement mindset throughout the organization by encouraging experimentation and learning.

Technical and Functional:

Compliance, Quality Systems and Validation

  • Lead the Site Compliance, Quality Systems & Validation program to ensure effective and efficient service to the site.
  • Develop strategies and plans for Compliance, Quality Systems & Validation for site in collaboration with senior management.
  • Review and approve all relevant Compliance, Quality Systems & Validation and other site documentation and ensure documentation supports a compliant state.
  • Provide expert interpretation and application of regulatory guidelines to ensure operations, facilities and documentation meet Roche standards and regulatory requirements.
  • Act as a liaison and SME to present Compliance, Quality Systems & Validation practices to Health Authorities and regulatory agencies.
  • Support regulatory inspections and provide audit support with your team, which may include presentations and facility, utility, equipment documentation review.
  • With your team, help define and ensure corrective and preventative actions are implemented in a robust and timely manner.

Compliance

  • Provide strategic direction and manage execution of regulatory inspections, internal and external audits and paper-based inspections (e. g. moderation during inspections, providing daily summaries of inspection progress, support of timely preparation of responses to observations, ensuring logistical/infrastructure requirements) 
  • Provide strategic direction and oversight for the establishment and execution of the site self-inspection program.  Ensure the program drives continuous improvement of the site’s systems, processes and operational performance.
  • Develop, lead, and execute inspection readiness activities for site
  • Accountable for the response process and follow up on the mitigation activities, including coordination and interface with Global Functions and/or network sites as required.
  • Lead Supplier Management, including Direct Materials and Medical Devices: responsible for the monitoring of local supplier’s compliance with the requirements of cGMPs and applicable regulations, perform audits of external locally managed suppliers and/or interface with SQM team as defined by site.
  • Establish, negotiate and maintain Quality Agreements in close collaboration with SMEs, Contract Management group and business partners Quality and Service Level Agreements.
  • Liaison with PT Regulatory, lead coordination between site and PTR in close collaboration with site QA and site QS/QV. 
  • Supports Site Quality Head in terms of compliance questions, works together with other departments e.g. local manufacturing site, global functions like GQIM, External Relations
  • Interface with Affiliates to maintain import licenses, support local Business Operations Functions to maintain and keep the necessary Wholesaler and Distribution Licenses if applicable

Quality System

  • Direct staff to ensure that Quality Systems are maintained in compliance with Health Authorities, regulatory agencies, current Good Manufacturing Practices (cGMPs) and Roche policies and procedures.
  • Ensure maintenance and continuous improvement of Pharma Quality Systems processes. Establish and maintain Quality Strategy, Quality Master Plan, and TCM for Quality Assurance. Facilitate and coordinate Quality System Management Review for site (e.g. Site Quality Council)
  • Oversee Risk Management and provide relevant tools and expertise.  Ensure potential product and patient risks are systematically assessed, controlled, reviewed and communicated, and that risk management activities are documented appropriately.
  • Oversee and guide document center, records and document change management systems and processes.
  • Support timely preparation of the APQRs and improvement action plans as necessary, including annual updating of the Site Master File.
  • Provide training oversight for the site quality department concerning the GMP training and quality systems-related training.

Quality Validation

  • Oversee and guide the technical strategy and direction of validation activities for the site in the preparation and execution of validation protocols, including facility, utilities, equipment, cleaning, and computer system validation.
  • Review and approve site Validation Master Plan (VMP)/project plans and ensure the strategy outlined meets business and regulatory requirements.  As needed, review and approve validation protocols, engineering change orders, SOPs, engineering commissioning and turnover packages.
  • Provide input and review for site-specific and corporate validation procedures and shared practices as applicable and in accordance with the requirements set forth in the governing quality standards in partnership with Global Quality.
  • Oversee and guide execution of the validation of tech transfer oversight, new facility expansions and construction projects.

Key lnterfaces

  • Compliance, Regulatory, Health Authorities
  • Global Quality System and Quality Management, all Site functions.
  • MSAT, Validation network team, Local Change Control Board
  • Global Quality Systems, Global APQR, QSMR, TCM, Global Change Control Board

Qualifications (education/experience/knowledge/skills/competencies)

Education

  • Bachelor's Degree (science or engineering is preferred)
  • Graduate or higher-level Degree is preferred

Experience 10 or more years work experience in the pharmaceutical or related industry

  • 6 or more years’ people management experience
  • 4 or more years’ experience in the validation of pharmaceutical manufacturing facilities, equipment and computers

Knowledge/Skills/Competencies

  • Expert knowledge of Quality System principles, practices and standards for the pharmaceutical industry
  • Expert knowledge of cGMP relevant to the pharmaceutical industry; knowledge of the local and international GMP Regulations
  • Expert knowledge with audit or inspection management

Who We Are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

The next step is yours. To apply today, click on the "Apply online" button.

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.


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