GMP QA Manager at Exelixis, Inc. in Alameda, California

Job Description:

Company Description

Every Exelixis employee is united in an ambitious cause: to launch innovative medicines that give patients and their families hope for the future. In this pursuit, we know our employees are our most valuable asset. After operating in the challenging biotech sector for 25 years, we have a proven track record of resiliency in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing us to reinvigorate our research efforts, and grow our team in areas such as Drug Discovery, Clinical Development and Commercial.

As we expand our global partnerships and further reinvest in R&D to help us discover the next breakthrough for difficult-to-treat cancers, we're seeking to add talented, dedicated employees to power our mission.

Cancer is our cause. Make it yours, too.

Position Description:

Responsible for the QA oversight of day-to-day GMP Operations at the Contract Manufacturing Organizations and Contract Labs that generate Exelixis products. Assists in the management of Exelixis partnerships and collaborations. Assists in conducting audits of vendors and associated documentation activities.

Position Requirements:

ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Develops, establishes and maintains the QA programs, policies, and procedures to ensure GMP compliance of commercial and clinical trial material.
• Performs record review, and disposition activities for commercial and clinical trial material including conducting the comprehensive Quality assessment.
• Coordinates investigations with vendors and interdepartmental teams to resolve potential product quality issues.
• Oversees the generation, review and/or approval of internal and external documents used in GMP activities.
• Provides support to the QA Site Manager to manage vendors, contract facilities and joint development collaborators for contracts, validation activities, change management and other QA issues.
• Supports the implementation of other quality systems, including departmental and corporate procedures, to ensure compliance with GMPs.
• Understands regulatory agency policies and guidance as it pertains to QA issues.
• Assists in monitoring current and proposed quality and scientific issues and advises supervisor on events for Exelixis.
• Provides support as needed for the review various quality review/approval documents such as, but not limited to, manufacturing, testing and labeling/packaging batch records, and CMC documents submitted to regulatory agencies.
• Authors work instructions and standard operating procedures.

SUPERVISORY RESPONSIBILITIES:
• No supervisory responsibilities.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
• BS/BA degree in related discipline and seven years of related experience; or, MS/MA degree in related discipline and five years of related experience; or, PhD in related discipline and three years of related experience, or; Equivalent combination of education and experience.
• Experience in the biotech or pharmaceutical industry is preferred.
• Experience in drug substance /API manufacturing is preferred.
• Experience in CMO oversight is preferred.

Knowledge/Skills:
• Working knowledge of the commercial and clinical manufacturing and quality processes, including US and EU regulations affecting the pharmaceutical industry.
• Has extensive experience in a virtual manufacturing environment or relevant industry/profession.
• Small molecule technical knowledge required. Oral solid dosage form strongly desired. Familiarity with serialization is desired.
• Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles, and to achieve goals in creative and effective ways.
• Develops technical solutions to complex problems.
• Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.
• Guides the successful completion of major programs, projects and/or functions.
• Interprets, executes and recommends modifications to companywide policies and/or divisional programs.
• Has complete understanding and wide application of technical principles, theories, concepts and techniques.
• Attention to detail when utilizing PC or reviewing documents and editing/proof-reading documents.
• Has extensive knowledge of other related disciplines.
• Applies strong analytical and business communication skills.
• Excellent verbal and written communication skills.
• Must be proficient in Word, Excel and PowerPoint.

WORKING CONDITIONS:
• Alameda Campus-Based

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DISCLAIMER

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.