Manager/Sr. Manager, QA

Role Summary

Manager/Sr. Manager of GMP QA Manufacturing provides on-the-floor quality oversight for GMP manufacturing activities related to API and Finished Drug Product. This role ensures compliance with global regulatory standards and internal quality systems, while supporting efficient and compliant product release. Reviews and approves executed batch records, deviations, investigations, change controls, and associated documentation; makes quality recommendations on the release of API and finished products to ensure only compliant materials are released.

Responsibilities

• GMP Oversight and Compliance
• Provide real-time QA oversight during manufacturing, packaging, labeling, and testing activities for API and Finished Drug Product
• Ensure that production operations comply with approved batch records, SOPs, and GMP regulations
• Perform line clearance, in-process checks, and review of critical operations
• Support internal and external audits, regulatory inspections, and readiness programs
• Batch Record Review and Product Release
• Review executed batch production and laboratory control records for completeness, accuracy, and compliance
• Assess and verify that all critical process parameters and quality attributes are met prior to batch release
• Ensure all associated documentation (deviations, change controls, investigations, analytical results, environmental monitoring, etc.) is resolved and approved before release
• Recommend or approve release of API and Finished Drug Product for commercial or clinical use in alignment with the QP/RP where applicable
• Maintain product disposition documentation within the eQMS
• Deviation and Investigation Management
• Lead or review deviations, OOS, and non-conformance investigations
• Ensure thorough root cause analysis and implementation of effective CAPAs
• Evaluate potential product impact and support decision-making on product disposition
• Change Control and Continuous Improvement
• Review and approve manufacturing-related change controls to ensure risk assessments and validation requirements are appropriately addressed
• Identify opportunities for process and system improvement through trend analysis and quality metrics
• Support implementation of Quality Risk Management principles in daily operations
• Cross-Functional Collaboration
• Collaborate with Manufacturing, QC, Supply Chain, Technical Operations, and Regulatory Affairs teams to ensure timely and compliant manufacturing operations
• Provide quality input during production planning, tech transfers, process validation, and PPQ
• Participate in cross-functional quality review boards and risk assessment teams
• Documentation and Training
• Ensure manufacturing documentation (batch records, SOPs, forms) is current, accurate, and approved per QA procedures

Qualifications

• 7+ years of experience in GMP Quality Assurance or Manufacturing within the pharmaceutical or biopharmaceutical industry
• Minimum 3 years in a QA review/release capacity (API and/or finished drug product)
• Strong understanding of cGMP, ICH, and global regulatory requirements
• Experience with contract manufacturing oversight and batch release processes

Skills

• Excellent attention to detail and technical writing skills
• Strong communication and decision-making abilities
• Proficiency with eQMS systems (e.g., Veeva, TrackWise, MasterControl)
• Ability to interpret complex quality data and make sound, compliant decisions
• Ability to build relationships and work collaboratively with a variety of individuals within the department, company, and external vendors
• Team-oriented with the ability to communicate quality guidance cross-functionally

Education

• Bachelor‚Äôs degree in Chemistry, Biology, Pharmacy, Chemical Engineering, or related scientific discipline

Additional Requirements

• This is a U.S.-based remote role with quarterly or as-needed visits to the San Francisco Office and to global vendors/partners