Associate Director, Quality Assurance Operations
Alkeus Pharmaceuticals, Inc. is a late-stage biopharmaceutical company developing transformative therapeutics to address serious, progressive eye diseases that lead to blindness. Our lead compound, gildeuretinol (ALK-001), is an oral investigational drug being developed for the treatment of Stargardt disease (STGD) and Geographic Atrophy (GA) secondary to dry age-related macular degeneration. For additional information, please visit our website at www.alkeuspharma.com.
Position Summary
This role is instrumental in driving the successful development and launch of innovative therapies to address unmet medical needs. The Associate Director of QA Operations will lead the GMP QMS activities and oversight over the manufacturing, testing, and distribution of a small molecule drug, and directly support the transition to commercial drug product manufacturing and distribution. The ideal candidate will bring hands-on operational QA experience with GMP and GDP to our fast-paced collaborative environment.
Primary Responsibilities
- Disposition of small molecule Drug Substance (API), Bulk Drug Product, and Finished Drug Product for release to forward processing or for distribution.
- Review of CDMO batch records, Certificates of Analysis (CoA), and Certificates of Conformance to ensure all products and processes comply with the relevant specifications, regulations and guidance.
- Review and approve specifications, CoAs for critical raw materials, small molecule GMP intermediates, API, Bulk and Finished clinical and commercial Drug Products.
- Partner with Alkeus CMC and Supply Chain and with the QA/QC functions at CDMOs and Contract Labs to assess and mitigate risks and to ensure quality and GMP compliance throughout the product life-cycle.
- Initiate and lead QMS processes to completion for Deviations, CAPA, Change Control, etc., working in partnership with the Alkeus CMC and Supply-Chain, and in collaboration with the CDMOs/CMOs/Labs.
- Support OOS/OOT investigations and resolution in partnership with the Alkeus CMC group and with CDMOs/CMOs/Labs.
- Development of GMP Governing Documents (Policies, SOPs, Work Instructions, Templates, Forms, etc.).
- Coordinate the GMP audit program including scheduling and tracking supplier audit execution and follow-up actions.
- Perform internal and external GMP audits and compliance assessments.
- Ensure compliance with FDA regulations and other relevant industry regulations, guidance and standards.
Leadership and Strategy:
- Lead the QA-operations function within the organization.
- Develop and implement quality strategies including transition from clinical to commercial manufacturing and distribution.
- Gain expertise with the electronic quality management system (eQMS) and guide others in its use.
- Support QA organization Development.
- FDA Inspection-Readiness for GMP processes and activities.
- This role involves maintaining high standards of quality, ensuring regulatory compliance, and driving continuous improvement in pharmaceutical QA operations.
Skills and Qualifications:
- Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biotechnology, etc.) or related field; advanced degree preferred.
- Minimum of 8-10 years of experience in QA within the pharmaceutical industry, with at least 3-5 years in a managerial role in clinical and commercial QA. Direct experience with small molecule oral dosage forms is a strong plus.
- In-depth knowledge of FDA regulatory requirements and industry standards for GMP and GDP.
- Direct experience with virtual operations and Quality oversight of remote Vendors (CDMOs, QC Labs, Distributors, etc.) is required.
- Prior experience in, or partnering on the qualification of GMP facilities and equipment and the validation of Drug Substance and Drug Product is highly desirable.
- Prior experience in QC will be a valuable asset for this role.
- Excellent leadership, communication, and interpersonal skills.
- Strong analytical and problem-solving abilities.
- Ability to work independently and collaboratively in a fast-paced, dynamic environment.
Skills and Key Success Factors:
- Entrepreneurship spirit with a passion to build, learn and evolve with the team.
- Highly organized and detail oriented with a passion to deliver quality results.
- Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit.
- Ability to lead fast-paced projects with a keen sense of urgency to get the job done well.
- Evidence of "hands-on" experience and expertise.
- Proven and successful track record as a team-player and collaborator in small working environments.
- Highest levels of professionalism, confidence, personal values, and ethical standards.
- Ability and aptitude to manage ambiguity and adaptability to change.
- Emphasize the need for self-motivation and the ability to work independently.
Other Relevant Information:
Travel: Occasional US or International travel may be required.
Alkeus Pharmaceuticals, Inc., is an equal opportunity employer and considers all qualified applicants for employment without regard to any characteristic protected by applicable law. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Seniority level: Director
Employment type: Full-time
Job function: Quality Assurance
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