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Director, GMP Quality Assurance

1 month, 3 weeks ago
United States
Full-time
Lead
Manual QA Tester
Quality Assurance and Testing
Apply Now
Apogee Therapeutics

Apogee Therapeutics

Apogee Therapeutics, Inc. is a biotechnology company dedicated to developing innovative biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease, and other inflammatory and immune diseases with high unmet needs. Their goa...

Biotechnology
1-10
Founded 2022
$169M raised
View All Jobs 20

Description

  • Assist QA leadership with developing and executing planned QA audit schedules supporting GMP activities.
  • Partner with Technical Operations to select and oversee drug substance and drug product CDMOs for Phase 3 and PPQ activities.
  • Conduct assigned GMP audits independently.
  • Provide quality guidance on GMP data and documentation generated by Technical Operations.
  • Verify that manufacturing and testing activities comply with GMP regulations, guidelines, and industry standards.
  • Review and release batches in a timely manner to support continuous supply for clinical trials.
  • Support quality assurance for device development activities, including pre-filled syringes and autoinjectors.
  • Maintain GMP quality systems, including documentation, change control, deviations, CAPA, and quality events.
  • Implement risk-based quality management approaches and help identify and mitigate quality risks.
  • Establish and report key quality metrics to monitor performance and drive improvements.
  • Ensure employees are trained on GMP requirements and quality procedures.
  • Support GMP inspection readiness activities for regulatory authority inspections.

Requirements

  • Bachelor’s degree in a relevant scientific discipline or equivalent is required; advanced degree is a plus.
  • 10+ years of GMP quality assurance experience in the biotech or pharmaceutical industry.
  • Direct experience auditing and supporting the manufacture of monoclonal antibodies or biologics.
  • Experience with CDMO oversight and aligning on quality issues.
  • 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 an electronic QMS to track quality tasks and key quality performance indicators.
  • Strong oral and written communication skills with the ability to influence and drive change.
  • Excellent problem-solving and critical thinking abilities.
  • Ability to manage multiple projects with fast timelines and changing priorities.
  • Up to 20% travel required, including mandatory in-person attendance at All Hands meetings typically held twice per year.
  • Experience with Quality Management System Regulations is a plus.

Benefits

  • Anticipated salary range of $210,000-$235,000.
  • Market-competitive compensation package including base salary, performance bonus, and equity grant opportunities.
  • Health, welfare, and retirement benefits.
  • Three weeks of PTO, plus two one-week company-wide shutdowns each year and paid sick leave.
  • Professional development support and access to resources to grow your career.
  • Regular all-team in-person meetings to strengthen relationships and solve problems.
  • Fast-paced, dynamic environment with the opportunity to shape the company and take on multiple roles.

Interested in this position?

Apply directly on the company website

Apply Now

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