/ Hiring

Manager, Commercial Drug Product Manufacturing QA

Who We Are

At the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work.

The Position

MainPurpose of the Position:

• Lead the planning, preparation, and conduct of QualityAssurance staff performing a variety of routine and complex oversightactivities that meet cGMP regulations and Genentech standards.
• Lead DP MQA performance and development of direct reports toensure achievement of organizational and department goals and a productive environment.

JobDuties/Responsibilities:

• Coach and develop staff by providing an environment thatencourages ongoing personal and professional development.  Manage and ensure the setting of realisticgoals for staff and provide regularly scheduled feedback throughout theyear.  Ensure staff receives appropriateknowledge and skill development and growth opportunities.
• Manage and administer all aspects of people processesrelated to the employee life cycle.  Thisincludes the selection, hiring and training of personnel on company anddepartment policies, systems and processes. Manage and communicate compensation related information per companyguidelines.
• Accountable for systems to ensure anynon-compliant events occurring in Manufacturing are assessed in a timely manneran in compliance with Quality policies and Health Authority expectations.
• Accountable for systems to ensure documentationis reviewed in a timely manner and with a high level of accuracy.
• Guide staff in meeting goals by identifying and completingassignments.
• Recommend and implement improvements to Qualityoperational policies, plans and procedures.
• Manage routine department activities and complexQuality initiatives.
• Ensure activities and initiatives are completedon time and within budget.
• Maintaincapacity model to ensure appropriate resourcing of the area.
• Presentcomplex quality issues and potential solutions at site leadership teams (QRB,Quality Council, SMART)
• Monitor and control expenditures against the departmentbudget.
• Notify Senior Management of potential quality or regulatory issues thatmay impact product quality or regulatory compliance.
• Lead and participate in continuous improvementinitiatives for Roche Quality Systems.
• Sign documents foractivities as authorized and described by Roche policies, procedures and jobdescriptions.
• Be accountable forbehaviors described in Roche’s values and Leadership Competencies.
• Perform any other tasks as requested by SeniorManagement to support Quality oversight activities.

General:

• As required, serve as a Quality liaison with regulatoryagencies and external sources regarding issues impacting quality assurancemanufacturing.

Manufacturing Quality Assurance/EnvironmentalQuality Assurance:

• Represent MQA as the prime internal and external contact oncontracts and operations.
• Guide staff in supervising and integratingquality oversight into manufacturing operations.

Who You Are

Qualifications  (Education, Experience, Knowledge, Skills):

• B.A. or B.S. degree (preferably in Life Science) and eightyears of relevantexperience in the pharmaceutical or biopharmaceutical industry, including threeor more years ofsupervisory experience, or an equivalent combination of education andexperience
• Sound knowledge of cGMPs or equivalent regulations 
• Ability to interpret and relate Quality standards for implementationand review
• Ability to make sound decisions aboutscheduling, allocation of resources, and managing priorities
• Ability to communicate clearly and professionally both inwriting and verbally
• Flexibility in problem solving, providingdirection and work hours to meet business objectives

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

Genentech is an Equal Opportunity Employer.