Executive Director – GMP Quality Assurance

This is a fully remote position, open to applicants in United States.

📋 Description

• Head of GMP QA and a key member of the QA Leadership Team

• Build, lead, and expand a high-performing GMP QA team

• Develop and implement the GMP QA functional strategy, ensuring alignment with company goals and the evolving needs from clinical to commercial phases

• Establish a clear GMP QA vision that promotes inspection readiness, scalability, and sustainable operations

• Oversee GMP QA systems, including deviations, investigations, CAPAs, change control, complaints, and product disposition

• Ensure adherence to relevant global GMP regulations and standards (e.g., FDA, EMA, ICH)

• Lead the organization's preparedness for GMP internal audits and regulatory inspections

• Provide strategic oversight of GMP QA across CMOs, CDMOs, and external testing partners

• Ensure the implementation and active management of effective quality agreements, oversight models, escalation pathways, and performance metrics

• Exercise sound judgment in promptly resolving quality issues with external partners in a compliant manner

• Engage effectively with leadership and key cross-functional partners, presenting clear recommendations and risk-based insights

• Lead the development and presentation of Quality Management Review meetings for GMP QA, emphasizing compliance needs and fostering continuous improvement initiatives to enhance speed, clarity, and scalability

⛳️ Requirements

• Over 15 years of progressive GMP QA experience in pharmaceutical, biotechnology, and/or medical device sectors, with a thorough understanding of global GMP regulations across clinical and commercial operations

• Proven success in leading GMP QA organizations through transitions from clinical development to commercial manufacturing, including launch readiness and post-approval operations

• Demonstrated ability to build, scale, and maintain GMP Quality Systems that support commercial supply, including serving as the functional lead for the Veeva Quality Suite (QMS) with accountability for system strategy, governance, and compliance across both internal teams and external partners

• Extensive experience in overseeing external manufacturing and testing partners, as well as directly leading regulatory inspections and interactions with global health authorities

• Significant leadership experience, including the management of managers and senior-level professionals; adept at coaching and developing leaders through periods of change and uncertainty

• Capacity to create and clearly communicate a GMP QA vision that aligns with company strategy, establishing trust and credibility across teams, while setting clear direction and adapting leadership style to meet 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 abilities

• Capability 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 held typically twice a year and travel associated with GMP manufacturing

🏝️ Benefits

• A vibrant culture, anchored in our C.O.R.E. values: Caring, Original, Resilient, and Egoless

• Opportunity to thrive in a fast-paced, dynamic environment where you can influence the culture and company, take on multiple roles, and learn rapidly

• Competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, and health, welfare & retirement benefits

• Generous time off policy, featuring three weeks of PTO, two one-week company-wide shutdowns each year, and dedicated paid sick leave

• A strong commitment to your professional growth, providing access to resources for further development

• Regular in-person meetings for the entire team to build relationships and collaboratively problem-solve