Senior Operations QA Manager - Commercial

SUMMARY/JOB PURPOSE:

The Senior Operations QA Manager – Commercial 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 late-stage and commercial products, including batch record review, assessment, rapid escalation and issue resolution, release per supply plans, managing product complaints.

This person will assist in the management of Exelixis partnerships, collaborations, and audits and forge strong relationships.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

 As QA Core, support QA Partner:

• Maintains and continuously improves QA programs, policies, and procedures to ensure GMP compliance of commercial material.

• Performs record review and batch disposition for commercial material.

• Oversees CMOs: Deviations, CAPAs, , rapidly escalate and resolve issues.

• Generates, reviews/approves internal and external GMP records (MBR and EBR (master and executed batch records), stability reports/protocols, specifications, deviations, change controls, etc.)

• Maintains and reports CMO metrics and QA metrics.

• Identifies and rapidly mitigates risk.

• Contributes to APQR (annual product quality review) as applicable.

• Support implementation of quality systems and 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 and 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 of experience managing Contract Manufacturing Organizations preferred

• Five years of general experience in the biotech/pharmaceutical industry.

• Experience in the 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.

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

• 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.

WORKING CONDITIONS:

• This is an onsite position

• Travel as required

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