Senior Operations QA Clinical GLP Manager

SUMMARY/JOB PURPOSE:

The Senior Operations QA Clinical GLP Manager is accountable for assisting in the development, implementation and maintenance of end-to-end QA processes and activities, including GLP operations. Provide Operations 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, and managing product complaints.

Represents QA as the QA Partner (Primary Point of Contact), speaking One Voice for Quality for Exelixis business stakeholders, represents QA in an outwardly and business-facing capacity, in strategic and decision forums, and triages communication between Exelixis business functions, internally or externally, and QA, to provide and ensure delivery on the company core goals and pipeline deliverables.

Manages Exelixis partnerships, collaborations. audits, forges strong relationships to maintain performance and continuous improvement.

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

ESSENTIAL DUTIES/RESPONSIBILITIES:

• Represent QA as the QA Partner (Primary Point of Contact) (vendors, CMOs, development collaborators for contracts, validation, change management, GMP and GLP issues).

• Develop, implement, and continuously improve QA programs, policies and procedures to ensure GMP and GLP compliance of clinical trial material, and onsite labs.

• Perform record review, and batch disposition for commercial and clinical trial material, including comprehensive Quality assessment, and review of GLP documents and records.

• Oversee CMOs and GLP vendors, as applicable: Issue/deviation management, CAPAs with vendors and cross-functional teams to resolve potential product quality issues, 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, testing and labeling/packaging records, development/CMC documents submitted to regulatory agencies, GLP documents and records, etc.)

• Responsible for developing, tracking and managing periodic management reports, including key GMP and GLP compliance and QA metrics, as applicable.

• Maintain and report CMO metrics and Operations QA metrics. Evaluate and generate data to support KPIs (Key Performance Indicators).

• Identify and rapidly mitigate risk.

• Independently determines approach to complex compliance issues and rapidly escalates reports findings, with recommendations for resolution, and verifies that appropriate CAPAs were implemented and documented.

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

• Support implementation of quality systems, departmental and corporate procedures, to ensure compliance with cGMPs and GLP.

• Partners with Regulatory Affairs, Clinical Pharmacology, Translational Medicine, PSC, PSC Analytical, and R&D as it pertains to GLP, etc., regarding compliance issues, provides compliance guidance to all audited parties.

• Maintains knowledge of current regulation requirements; informs stakeholders of potential impact on the organization.

• Deliver per supply plans, drive results.

SUPERVISORY RESPONSIBILITIES:

• No supervisory responsibilities.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education:

• 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:

• 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 and Abilities:

• Demonstrated knowledge of the drug development processes

• Demonstrated GLP audit conduct and management experience is required.

• Working knowledge of supporting GLP preparation and submission activities for global regulatory filings.

• 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.

• Requires a broad range of knowledge and experience with biologic and chemical processes, drug development, analytical testing methods, laboratory practices and tox studies, and understanding of the international regulatory landscape.

• 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.

Work Environment/Physical Demands:

• This is an onsite position

• Our office is a modern, open-plan space that foster collaborations and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.

• This position requires up to 5% travel.

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