Director, GMP Quality Assurance

Apogee Therapeutics

Director of GMP Quality Assurance ensuring the quality of biologics manufacturing processes and device development at Apogee Therapeutics. Leading QA audits and maintaining compliance with regulation standards.

Posted 4/27/2026full-timeRemote • 🇺🇸 United StatesLead💰 $210,000 - $235,000 per yearWebsite

About the role

Key responsibilities & impact

Assist QA Leadership with development and execution of planned QA audit schedules supporting GMP activities
Partner with Technical Operations with selection and ultimate oversight of drug substance / drug product contract development manufacturing organizations (CDMOs) in support of Phase 3 and process performance qualification (PPQ) activities
Independently performs assigned GMP audits
Partner effectively with Technical Operations and provide quality guidance in GMP data and documentation generated
Verify manufacturing and testing activities adhere to GMP regulations and guidelines and ensure a culture of continuous improvement
Timely management of batch record review and release to ensure continuous supply for clinical trials, and to guarantee the consistent production of high-quality products
Ensure manufacturing processes, facilities, and systems adhere to current GMP regulations, guidelines, and industry standards
Provide QA support of device development activities (pre-filled syringes, autoinjectors, etc.)
Maintain robust GMP quality systems, including documentation, change control, deviations, CAPA, and quality events
Maintain knowledge of current regulatory changes and industry trends and translate new requirements back to the company’s policies and procedures
Implement risk-based approaches to quality management, identifying and mitigating quality risks across the organization
Assist in establishing and reporting key quality metrics to monitor performance and drive improvements in GMP compliance and product quality
Drive a culture of continuous improvement, identifying areas for enhancement in quality systems and processes to enhance efficiency and effectiveness
Ensure employees are adequately trained in GMP requirements and quality procedures
Maintain comprehensive and accurate records and reports related to quality assurance activities
Foster a culture of quality within the organization, emphasizing the importance of compliance, data integrity, and patient safety
Assist in GMP inspection readiness activities to support regulatory authority inspections

Requirements

What you’ll need

A bachelor’s degree in relevant scientific discipline or equivalent is required, advanced degree a plus
A minimum of 10 years of experience in GMP quality assurance within the biotech or pharmaceutical industry, with direct experience in auditing and the manufacture of monoclonal antibodies or biologics
Experience with CDMO oversight, including partnering and aligning on quality issues
Experience with Quality Management System Regulations is a plus
In-depth knowledge of GMP regulations and guidelines, including FDA, EMA, and ICH requirements
Experience with analytical instrumentation, methods, validation, and investigations including stability program management
Extensive experience using electronic QMS to monitor, report, and track quality tasks, and key quality performance indicators
Strong communication (oral and written), and effective interpersonal skills with the ability to influence and drive change
Excellent problem-solving and critical thinking abilities
Flexible and creative to meet the needs and challenges of a growing, dynamic company
Focus on fostering a culture of collaboration and teamwork
Ability to manage multiple projects with fast timelines and changing priorities
Position requires up to 20% travel including mandatory in-person attendance at All Hands meetings typically held twice per year

Benefits

Comp & perks

A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

ATS Keywords

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Hard Skills & Tools

GMP auditingquality management systemsanalytical instrumentationstability program managementCAPAdeviations managementrisk-based quality managementquality metrics reportingdocumentation controlbiologics manufacturing

Soft Skills

communication skillsinterpersonal skillsproblem-solvingcritical thinkingflexibilitycreativitycollaborationteamworkinfluencing skillsproject management