Senior Operations QA Manager - Clinical (Core)

SUMMARY/JOB PURPOSE:

The Senior Manager, Operations QA - Clinical is accountable for the QA oversight of day-to-day end-to-end (Drug Substance, Drug product, Finished Goods) GMP Operations at the Contract Manufacturing Organizations (CMOs) that manufacture and test Exelixis development and clinical products, including batch record review, assessment, rapid escalation and issue resolution, release per supply plans, managing product complaints.

Assists in the management of Exelixis partnerships, collaborations. audits , and forges strong relationships.

Demonstrates a high level of independent quality judgment and acumen, and knowledge and experience with biologic and chemical processes, drug development, analytical testing methods, and understanding of the international regulatory landscape.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

As QA Core, support QA Partner

• Maintain and continuously improve QA programs, policies and procedures to ensure GMP compliance of clinical trial material.
• Perform record review, batch disposition for clinical trial material.
• Oversee CMOs: Deviations, CAPAs, rapidly escalate and resolve issues.
• Generate, review/approve internal and external GMP records (MBR and EBR (master and executed batch records), stability reports/protocols, specifications, deviations, change controls, etc.)
• Maintain and report CMO metrics and QA metrics.
• Identify and rapidly mitigate risk.
• Contribute to APQR (annual product quality review) as applicable.
• Support implementation of quality systems, departmental and corporate procedures, to ensure compliance with cGMPs.
• Evaluate and generate data to support KPIs (Key Performance Indicators)
• Understands regulatory requirements.
• Deliver per supply plans, drive results.

SUPERVISORY RESPONSIBILITIES:

None

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• Bachelor's degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 9 years of related experience; or,
• Master's degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 7 years of related experience; or,
• PhD in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 2 years of related experience; or,
• Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

• A minimum of 8 years of related QA experience or the equivalent combination of experience and education/training. Experience in the biotech or pharmaceutical industry, and clinical packaging/labeling activities is preferred
• Two years' experience managing Contract Manufacturing Organizations preferred
• Five years general experience in biotech/pharmaceutical industry.
• Experience in development of metrics and continuous improvements is preferred

Knowledge/Skills:

• Working knowledge of the end-to-end commercial and clinical manufacturing and quality processes, including US/EU regulations affecting the pharmaceutical industry, and ICH guidelines.
• Proven experience in a virtual manufacturing environment or relevant industry/profession.
• Small molecule, oral solid form, biologics technical knowledge required.
• Uses broad expertise or unique knowledge and skills to drive meeting company core objectives and principles, and to achieve goals in creative and effective ways.
• Implements technical solutions within quality requirements to complex problems.
• Interprets, executes and recommends modifications to companywide policies and/or divisional programs.
• Great attention to detail.
• Applies strong analytical and business communication skills. Evaluates and generates data to support departmental metrics
• Excellent written, verbal and presentation communication skills, able to translate complex concepts across all levels of the organization.
• Excellent MS Office, Word, Excel and PowerPoint skills.

JOB COMPLEXITY:

WORKING CONDITIONS:

• Travel as required