Associate Director, GMP Quality Assurance

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. This role is essential in supporting our mission to develop and deliver differentiated biologic therapies to patients in need.

Key Responsibilities

• Lead and support QA activities for downstream manufacturing, including Drug Product, Finished Drug Product, and devices such as pre-filled syringes and auto-injectors
• Maintain and enhance robust GMP quality systems encompassing documentation, change control, deviations, CAPA, quality events, and continuous improvement initiatives
• Stay current with regulatory changes, industry trends, and implement new requirements into company policies and procedures
• Utilize risk-based approaches to quality management, proactively identifying and mitigating quality risks across the organization
• Develop, monitor, and report key quality metrics to drive GMP compliance and improve product quality
• Ensure all personnel are adequately trained in GMP requirements and quality procedures
• Keep comprehensive and accurate records and reports of all quality assurance activities
• Foster a culture focused on quality, compliance, data integrity, patient safety, collaboration, and teamwork
• Prepare and support the organization for regulatory authority inspections and maintain inspection readiness
• Collaborate with cross-functional teams to solve problems and drive innovation in quality systems and processes

Ideal Candidate

• A bachelor’s degree in relevant scientific discipline or equivalent is required
• A minimum of 7 years of experience in GMP quality assurance within the biotech or pharmaceutical industry, with direct experience in the manufacture of monoclonal antibodies or biologics
• Knowledge of medical device Quality System Regulations with direct experience in 21 CFR Part 4, Part 820, ISO 13485 and ISO 14971.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
• Experience using electronic QMS to monitor, report, and track quality tasks, and key quality performance indicators
• Demonstrated strong oral and written communication skills, along with effective interpersonal abilities to influence, drive change, and foster a collaborative, team-oriented culture
• Proven excellence in problem-solving and critical thinking, with flexibility and creativity to address the challenges of a dynamic, growing organization
• Skilled in managing multiple projects simultaneously, effectively prioritizing and adapting to aggressive timelines and shifting priorities
• Position requires up to 20% travel including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year

The anticipated salary range for candidates for this role will be $160,000-$185,000 / year. 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.