Senior Operations QA Clinical GLP Manager

Role Summary

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.

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, 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.

Qualifications

• Bachelor's degree in science and a minimum of 9 years of related experience; or, Master’s degree with 7 years; or PhD with 2 years; or equivalent combination of education and experience.
• A minimum of 8 years of related QA experience in biotech/pharmaceutical industry; experience with clinical packaging/labeling preferred.
• Two years’ experience managing Contract Manufacturing Organizations preferred.
• Five years general experience in biotech/pharmaceutical industry; experience in metrics and continuous improvements preferred.

Knowledge, Skills And Abilities

• Demonstrated knowledge of the drug development processes
• GLP audit conduct and management experience
• Working knowledge of GLP preparation and submission activities for global regulatory filings
• Working knowledge of end-to-end commercial and clinical manufacturing and quality processes, US/EU regulations and ICH guidelines
• Experience in a virtual manufacturing environment or relevant industry
• Broad knowledge of biologic and chemical processes, drug development, analytical testing methods, laboratory practices and tox studies, and international regulatory landscape
• Small molecule, oral solid form, biologics technical knowledge
• Strong analytical and business communication skills; ability to translate complex concepts
• Excellent MS Office skills

Education

• Bachelor's degree in science; or Master’s/PhD as noted in Qualifications

Additional Requirements

• This is an onsite position
• Up to 5% travel