Operations QA Manager - Commercial

SUMMARY/JOB PURPOSE:

The Operations QA Manager - Commercial is responsible for the QA oversight of end-to-end, day-to-day GMP Operations at the Contract Manufacturing Organizations (CMOs) that generate Exelixis products, including Drug Substance, Drug Product, Intermediates, Raw Materials, Packaging and Labeling.

Assesses vendor processes, systems and procedures to evaluate their quality performance against established standards and regulatory requirements. Reviews batch records. Part of Exelixis partnerships and collaborations to identify, rapidly mitigate and escalate risks to products.

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 QA 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 Partner 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.
• Drives for results

SUPERVISORY RESPONSIBILITIES:

• None

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• BS/BA degree in related discipline and a minimum of 7 years of related experience; or,
• MS/MA degree in related discipline and a minimum of 5 years of related experience; or,
• PhD in related discipline and 0 or more years of related experience; or,
• Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

• Experience in the biotech or pharmaceutical industry is required.
• 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, oral solid dosage form and biologics preferred.
• 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, written and presentation communication skills.
• Must be proficient in Word, Excel and PowerPoint.

JOB COMPLEXITY:

WORKING CONDITIONS:

• Onsite position
• Travel as required

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