Associate Director, GMP Quality Assurance
Apogee Therapeutics
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $160,000 - $185,000 per year
Job Level
About the role
- 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
Requirements
- 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
Benefits
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
GMP quality assuranceanalytical instrumentationquality metricsrisk-based quality managementstability program managementquality system regulations21 CFR Part 421 CFR Part 820ISO 13485ISO 14971
Soft skills
oral communicationwritten communicationinterpersonal skillsproblem-solvingcritical thinkingflexibilitycreativitycollaborationteam-orientedproject management