Assoc Gmp Quality Assurance Director - Clinical

• Ensures that the company maintains its right to operate at its Contract Manufacturing Organizations and Contract Laboratories.
• Provides support as needed for the review of manufacturing, testing and labeling/packaging batch records, and CMC documents submitted to regulatory agencies.
• Manages QA review of manufacturing records, clinical trial documentation and documents submitted to regulatory agencies.
• Oversees and manages the GMP auditing process, and all other relevant QA inspectional activities.
• Directs, establishes and maintains QA programs, policies, and procedures to ensure GMP compliance of clinical trial material.
• Acts as the primary QA contact with vendors, contract facilities and joint development collaborators for contracts, validation activities, change management and other QA issues.
• Understands regulatory agency policies and guidance as it pertains to QA issues.
• Assists in monitoring current and proposed quality, scientific and pertinent legal issues and advises management on events of significance for Exelixis’ business interests.
• Contributes to the company’s SOP system by authoring procedures related to GMP QA.

• None

• Equivalent combination of education and experience.
• BS/BA degree in related discipline and a minimum of 11 years of related QA experience; or,
• MS/MA degree in related discipline and a minimum of 9 years of related QA experience; or,
• PhD in related discipline and a minimum of 5 years of related QA experience; or

• Experience in the biotech or pharmaceutical industry is preferred.

• Working knowledge of ICH guidelines.
• Small molecule technical knowledge required. Oral solid dosage form strongly desired.
• Excellent verbal and written communication skills.
• Applies strong analytical and business communication skills.
• Has a significant amount of experience in a virtual manufacturing environment or relevant industry/profession.
• Interprets, executes and recommends modifications to companywide policies and/or divisional programs.
• Leads or manages the work of others by providing guidance to subordinates or teams based on organizational goals and company policy.
• Large molecule technical knowledge is a plus.
• Working knowledge of the commercial and clinical manufacturing and quality processes, including US and EU regulations affecting the pharmaceutical industry.
• Has complete understanding and wide application of technical principles, theories, concepts and techniques.
• Guides the successful completion of major programs, projects and/or functions.
• Leads the implementation of process and system improvements/initiatives with minimal guidance from group leader.
• Has extensive knowledge of other related disciplines.

• Works on problems of diverse scope where analysis or data requires evaluation of identifiable factors.
• Creates formal networks involving coordination among groups. Regularly interacts with executives and/or leadership from other functional groups.
• Demonstrates good judgment in selecting methods and techniques and obtains compliant solutions.
• Ensures budgets and schedules meet corporate requirements.

• Ability to travel up to 25% is expected for this position.

Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $146,000 - $207,500 annually. The base pay range may take into account the candidate’s geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate’s geographic region, job-related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.