We are seeking an Executive Director of GMP Quality Assurance (QA) to serve as a senior quality leader responsible for developing, leading, and executing the global GMP QA strategy in support of a transition from clinical development to commercial readiness. This role verifies compliance with cGMP regulations, company policies and procedures, and industry standards, while deliberately designing quality systems that enable speed, clarity, and confident decision-making as the company scales.

The Executive Director partners closely with cross-functional teams and external manufacturing and testing partners ensuring high standards of product quality and data integrity across GMP operations. They build and lead a high‑performing GMP QA team, provide strategic oversight of audits and inspections, and serve as a trusted advisor to senior leadership on GMP QA risk management. This position reports to the Head of QA.

Key Responsibilities

• Head of GMP QA and member of the QA Leadership Team
• Build, lead, and scale a high‑performing GMP QA team
• Develop and execute the GMP QA functional strategy, ensuring alignment with company objectives and evolving clinical‑to‑commercial needs
• Establish a clear GMP QA vision that enables inspection readiness, scalability, and sustainable operations
• Provide oversight of GMP QA systems, including deviations, investigations, CAPAs, change control, complaints, and product disposition
• Ensure compliance with applicable global GMP regulations and standards (e.g., FDA, EMA, ICH)
• Lead organizational readiness for GMP internal audits and regulatory inspections
• Provide strategic oversight of GMP QA across CMOs, CDMOs, and external testing partners
• Ensure effective quality agreements, oversight models, escalation pathways, and performance metrics are in place and actively managed
• Exercise sound judgment in resolving quality issues with external partners in a timely and compliant manner
• Engage effectively with leadership and key cross‑functional partners, bringing forward clear recommendations and risk‑based perspectives
• Lead the development and presentation of Quality Management Review meetings for GMP QA to highlight compliance needs and to foster continuous improvement initiatives to support speed, clarity, and scalability

Ideal Candidate

• 15+ years of progressive GMP QA experience within pharmaceutical, biotechnology, and/or medical device environments, with deep understanding of global GMP regulations across clinical and commercial operations
• Proven track record leading GMP QA organizations through the transition from clinical development to commercial manufacturing, including launch readiness and post approval operations
• Demonstrated success building, scaling, and sustaining GMP Quality Systems to support commercial supply, including serving as functional lead for the Veeva Quality Suite (QMS) with accountability for system strategy, governance, and compliance across internal teams and external partners
• Extensive experience overseeing external manufacturing and testing partners, and directly leading regulatory inspections and interactions with global health authorities
• Significant leadership experience, including managing managers and senior level professionals; effective at coaching and developing leaders through change and uncertainty
• Ability to create and clearly articulate a GMP QA vision aligned with company strategy, establish trust and credibility across teams, and set clear direction while adapting leadership style to organizational and individual needs
• Sound, unbiased judgment in complex and ambiguous situations; makes pragmatic, well-reasoned decisions, takes full ownership of outcomes, proactively addresses challenges, seeks feedback, and continuously adapts strategies based on evolving risks and business needs
• Strong written and verbal communication skills
• Ability to operate effectively in a fast‑paced, evolving environment with incomplete information
• Demonstrated commitment to Apogee’s C.O.R.E. values and ethical decision‑making
• Position requires up to 25% travel including mandatory in-person attendance at All Hands meetings typically held twice per year, additional travel may be required to attend visits to vendors, CDMOs, etc., domestic and international travel is required 

The anticipated salary range for candidates for this role will be $275,000-$305,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.

We are seeking a dynamic and results-driven Associate Director of GMP Quality Assurance (QA) to join our team. You will play a pivotal role in ensuring the quality, safety, and compliance of our biologics manufacturing processes and device development activities (pre-filled syringes, autoinjectors, etc.) This position will work closely with cross-functional teams to establish, maintain, and continually improve Apogee’s quality systems. You will support our mission to develop and deliver differentiated biologic therapies to patients in need.

Key Responsibilities

• 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

Ideal Candidate

• A bachelor’s degree in relevant scientific discipline or equivalent is required, advanced degree a plus
• A minimum of 8 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, additional travel may be required to attend visits to vendors, CDMOs, etc. domestic and international travel is required

The anticipated salary range for candidates for this role will be $165,000-$195,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.