Senior Manager, GMP QA

Senior Manager, GMP QA

W2 Contract

Pay Rate: $80 - $110 per hour

Location: Redwood City, CA - Hybrid Role

Job Summary:

We are seeking a Senior Manager, GMP Quality, who will play a key role within Quality Assurance and is responsible for providing leadership and operational support for our programs through different phases of development.

Duties and Responsibilities:

• Responsible for providing QA support for batch disposition, quality record ownership, and management of QA activities.
• Represent QA on cross-functional teams and serve as a resource for quality and compliance questions, issues, and planning across the development organization, including providing guidance based on current global regulations, industry standards, and best practices.
• Collaborate with internal and external stakeholders and execute quality systems as the QA SME on deviation investigations, CAPA plans, change controls, shelf-life extensions, revisions to documentation, and other Quality processes.
• Lead efforts for QA oversight of the c, Supply Chain, Analytical Development, and other functions.
• Establish and maintain internal quality metrics for the GMP Quality group that predict the performance and health of the quality systems and processes, and effectively communicate compliance-related metrics, risks, and compliance challenges to senior management.
• Provide Quality oversight as well as review and approval of CMO documentation (e.g., specification documents, Method Validations, Stability records, Master Batch records, label proofs, etc.), as well as review executed batch records, applicable test data (in-process and release), and perform product dispositions.
• QA lead in periodically reviewing and revising GMP-related SOPs and procedures.
• Support quality review of regulatory documents (IND/IMPD, NDA) to ensure compliance with late-stage and commercial drug product validation requirements.
• Participate in inspection readiness efforts, particularly for late-stage development and commercial launch preparations.
• Build positive professional relationships and trust to support learning, respect, open communication, collaboration, and teamwork.

Requirements and Qualifications:

• A Bachelor's degree in a scientific or technical discipline is required.
• A minimum of 8 years of experience in GMP Quality in the pharmaceutical industry, with experience in late-stage drug product development and validation, is required.
• Experience managing quality aspects of development, validation, manufacturing, and testing activities at CMOs.
• Experience in process validation (PPQ), late-stage regulatory submissions, and commercial readiness.
• Experience in Inspection Readiness (domestic and ex-US).
• Excellent analytical skills and a strong technical background in small molecule process development, validation, and testing are strongly desired.
• Knowledge of applicable US and Global compliance regulations and industry practices.
• Ability to critically evaluate and troubleshoot complex problems with diligence.
• Strong teamwork, collaboration, and management skills.
• Ability to manage multiple priorities and aggressive timelines.
• Highly responsible, self-motivated professional with enthusiasm and passion for the work.
• Highly proficient with various Microsoft and other computerized systems (e.g., Word, Outlook, Excel, PowerPoint, Visio, etc.).

Preferred Qualifications:

• Experience in auditing vendors and suppliers is preferred.

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as Inc.'s candidate.

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