Manager GMP Quality Operations

About the role

The GMP Quality Operations Manager is recognized internally as an expert in the principles and application of quality assurance, compliance, and AI-enabled quality operations. The Quality Manager will provide QA support of manufacturing operations for the external manufacture of Cell & Genetic Therapeutic programs.

Responsibilities

• Provide QA support of manufacturing operations for the external manufacture of Cell & Genetic Therapeutic programs.
• Drive, review, and support activities related to product disposition, including review of batch data, batch records, deviations, in-process data, EM data, QC release testing, and other quality systems documentation.
• Advance intelligent digitized solutions for backlog triage, metrics generation, records reconciliation, and archiving to improve operational efficiency, compliance, and data integrity.
• Partner with External CDMOs to identify any operational efficiencies and drive implementation.
• Identify compliance risks and gaps for GMP processes and support implementation of mitigating controls.
• Support audit and inspection readiness activities.
• Maintain periodic batch record metrics and assist department with routine/quarterly Quality System data review metrics and reporting.
• Develop intelligent digitized solutions for archiving and lifecycle management of GMP records to improve retrieval, traceability, compliance, and inspection readiness.
• Develop AI-enabled catch-up solutions to support backlog triage, prioritize quality records, and accelerate resolution of deviations, CAPAs, and batch disposition activities to improve overall Quality operations.
• Lead and participate in Cell & Genetic Program and Quality projects and drive continuous improvement activities.
• Implement AI-supported records reconciliation solutions to identify discrepancies, improve data integrity, and enhance completeness and accuracy of GMP documentation across quality systems and manufacturing records.

Requirements

• Bachelor's degree in a Business / Sciences field.
• 5+ years of QA experience in a GMP-regulated environment.
• Hands-on experience with ATMPs (cell therapy, gene therapy, tissue-engineered products) strongly preferred or with Biologicals/sterile.
• Demonstrated AI skills and digital capability to design and deliver intelligent solutions that improve Quality operations, including backlog triage, metrics generation, records reconciliation, and archiving within a GMP-regulated environment, while supporting data integrity, compliance, and risk-based decision-making.
• Demonstrated experience providing QA support to GMP manufacturing operation.
• Experience with network-based applications such as Oracle, TrackWise, Veeva.
• Ability to evaluate quality metrics, strong problem solving and make decisions utilizing risk-based approach.
• Proven experience leading a variety of projects/teams within stated objectives and timelines.
• Strong communication skills (written and verbal) with the ability to communicate effectively with cross functional team members, exchanging complex information and influencing/guiding others to understand a stated viewpoint.

Qualifications

• Hands-on experience with ATMPs (cell therapy, gene therapy, tissue-engineered products) strongly preferred or with Biologicals/sterile.
• Demonstrated AI skills and digital capability to design and deliver intelligent solutions that improve Quality operations, including backlog triage, metrics generation, records reconciliation, and archiving within a GMP-regulated environment, while supporting data integrity, compliance, and risk-based decision-making.
• Demonstrated experience providing QA support to GMP manufacturing operation.
• Experience with network-based applications such as Oracle, TrackWise, Veeva.
• Ability to evaluate quality metrics, strong problem solving and make decisions utilizing risk-based approach.
• Proven experience leading a variety of projects/teams within stated objectives and timelines.
• Strong communication skills (written and verbal) with the ability to communicate effectively with cross functional team members, exchanging complex information and influencing/guiding others to understand a stated viewpoint.

Skills

• AI skills and digital capability to design and deliver intelligent solutions that improve Quality operations, including backlog triage, metrics generation, records reconciliation, and archiving within a GMP-regulated environment, while supporting data integrity, compliance, and risk-based decision-making.
• Experience with network-based applications such as Oracle, TrackWise, Veeva.
• Ability to evaluate quality metrics, strong problem solving and make decisions utilizing risk-based approach.
• Strong communication skills (written and verbal) with the ability to communicate effectively with cross functional team members, exchanging complex information and influencing/guiding others to understand a stated viewpoint.

Benefits

• Annual bonus
• Annual equity awards
• Inclusive market-leading benefits to meet employees' financial, family, and wellbeing journeys
• Medical, dental, and vision benefits
• Generous paid time off (including a week-long company shutdown in the Summer and the Winter)
• Student loan repayment program
• Matching charitable donations
• 401(k)

Pay

$118,400 - $177,600