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Director, GMP Quality Assurance


About Apogee Therapeutics
Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally.
Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.”
We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless. All positions offer the flexibility to work remotely.
If this sounds like you, keep reading!
 
Role Summary
We are seeking a Director of GMP Quality Assurance (QA) who will be a key leader within the QA department and will play a pivotal role in ensuring the quality, safety, and compliance of our biologics manufacturing processes. 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
  • Head GMP QA and ensure a culture of continuous improvement
  • Ensure manufacturing processes, facilities, and systems adhere to current GMP regulations, guidelines, and industry standards
  • Provide QA oversight of device development activities (pre-filled syringes, autoinjectors, etc.)
  • Develop and maintain robust GMP quality systems, including documentation, change control, deviations, CAPA, and batch record review and disposition, to guarantee the consistent production of high-quality products
  • 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
  • Establish and report key quality metrics to monitor performance and drive improvements in GMP compliance and product quality
  • Lead the GMP vendor qualification program and activities including audits, assessments, and quality agreement negotiation to ensure quality of clinical trial materials and services
  • Drive a culture of continuous improvement, identifying areas for enhancement in quality systems and processes to enhance efficiency and effectiveness
  • Ensure personnel are adequately trained in GMP requirements and quality procedures
  • Maintain comprehensive and accurate records and reports related to quality assurance activities
  • Lead GMP inspection readiness activities to support regulatory authority inspections
Ideal Candidate
  • A Bachelor’s or Master’s degree in a relevant scientific discipline or equivalent
  • A minimum of 10 years of experience in GMP quality assurance within the biotech or pharmaceutical industry, with progressive leadership experience
  • Experience and knowledge of medical device Quality System Regulations preferred
  • Extensive experience using electronic QMS to monitor, report, and track quality tasks, and key quality performance indicators
  • In-depth knowledge of GMP regulations and guidelines, including FDA, EMA, and ICH requirements
  • Strong leadership, communication, and interpersonal skills with the ability to influence and drive change
  • Excellent problem-solving and critical thinking abilities
  • Ability to manage multiple projects with aggressive timelines and changing priorities
  • Ability and willingness to travel up to 20% (approximately 8-12 times per year for company meetings)
What We Offer
·       A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless. To learn more about our C.O.R.E. values and how they manifest day-to-day, click here
·       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
·       Flexible PTO
·       Two, one-week company-wide shutdowns each year
·       Commitment to growing you professionally and providing access to resources to further your development
·       100% remote with regular all team, in-person meetings to build relationships and problem solve
E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster.



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