Job Description

QA Change Control Manager, Pharmaceuticals, Consultant

Summary

Our client, a biopharmaceutical company dedicated to developing and commercializing novel therapies for diseases with significant unmet needs, particularly in eye care, has engaged with GForce to identify a Quality Assurance consultant. This person will be responsible for the review and processing of manufacturing Deviations and laboratory OOS and review of manufacturing and laboratory-related Change Controls within the established QMS system. This role will also be responsible for the approval of Certificates of Analysis, manufacturing batch record review, and product disposition.

Duties / Expectations of Role

• Support QA activities for early-phase (preclinical through clinical phase I/II) clinical development programs
• Ensure compliance with GMP in addition to internal policies and procedures
• Provide strategic QA input to cross functional teams, including Clinical, Regulatory Affairs, Analytical Development and CMC
• Serve as QA representative on development project teams and advise on risk mitigation strategies
• Contribute to the authoring and review of SOPs, protocols, reports and specifications
• Process and approve change controls, OOS and deviations within the QMS system
• Review and approve CMO’s master batch records, analytical documents and validation protocols
• Review executed batch records and disposition batches per internal policies and procedures
• Participate in CMO and internal operations meetings

Mandatory Requirements

• Bachelor’s or advanced degree in life science or a related field
• Sterile products experience
• 7-10 years of experience in Quality Assurance within the pharmaceutical / Biotechnology industry
• Experience in early-phase clinical development and a sound understanding of the drug development life cycle
• Strong knowledge of deviation and change control systems.
• Laboratory background with method methods
• Experience with investigations using root cause analysis, CAPA and CAPA effectiveness
• ASQ Certification Preferred

Term & Start

• 6-month contract with intent to convert to FTE
• Hybrid 2-3 days a week in Irvine, CA OR remote depending on candidate location/experience

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