Senior Director of Quality Assurance Operations
1 week ago
About Alkeus Pharmaceuticals
Alkeus Pharmaceuticals, Inc. is a late-stage biopharmaceutical organization focused on developing groundbreaking therapies for serious, progressive ocular diseases that can result in vision loss. Our primary investigational compound, gildeuretinol (ALK-001), is an oral medication under development for treating Stargardt disease (STGD) and Geographic Atrophy (GA) secondary to dry age-related macular degeneration. For more information, please visit our website.
Position Overview
This position plays a crucial role in facilitating the successful development and market introduction of innovative therapies aimed at addressing significant medical needs. The Associate Director of Quality Assurance Operations will oversee GMP Quality Management System (QMS) activities and provide supervision over the manufacturing, testing, and distribution of a small molecule drug, directly aiding the transition to commercial drug product manufacturing and distribution. The ideal candidate will possess practical operational QA experience with Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) in our dynamic and collaborative setting.
Key Responsibilities
- Oversee the release of small molecule Drug Substance (API), Bulk Drug Product, and Finished Drug Product for further processing or distribution.
- Examine CDMO batch records, Certificates of Analysis (CoA), and Certificates of Conformance to ensure compliance with relevant specifications, regulations, and guidelines.
- Review and authorize specifications and CoAs for critical raw materials, small molecule GMP intermediates, API, Bulk, and Finished clinical and commercial Drug Products.
- Collaborate with Alkeus CMC and Supply Chain, as well as QA/QC functions at CDMOs and Contract Labs, to evaluate and mitigate risks, ensuring quality and GMP compliance throughout the product lifecycle.
- Initiate and lead QMS processes to completion for Deviations, CAPA, Change Control, etc., in partnership with Alkeus CMC and Supply Chain, and in collaboration with CDMOs/CMOs/Labs.
- Assist in OOS/OOT investigations and resolutions in collaboration with the Alkeus CMC group and CDMOs/CMOs/Labs.
- Develop 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.
- Conduct internal and external GMP audits and compliance assessments.
- Ensure adherence to FDA regulations and other pertinent industry standards.
Leadership and Strategic Direction:
- Direct the QA operations function within the organization.
- Formulate and implement quality strategies, including the transition from clinical to commercial manufacturing and distribution.
- Gain proficiency with the electronic quality management system (eQMS) and guide others in its application.
- Support the development of the QA organization.
- Prepare for FDA Inspection-Readiness concerning GMP processes and activities.
- This role necessitates maintaining high-quality standards, ensuring regulatory compliance, and promoting continuous improvement in pharmaceutical QA operations.
Qualifications and Skills:
- Bachelor's degree in a scientific discipline (e.g., Chemistry, Biotechnology, etc.) or a related field; advanced degree preferred.
- A minimum of 8-10 years of experience in QA within the pharmaceutical sector, with at least 3-5 years in a managerial capacity in clinical and commercial QA. Direct experience with small molecule oral dosage forms is highly advantageous.
- Comprehensive 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 essential.
- Prior experience in, or collaboration 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.
- Exceptional leadership, communication, and interpersonal skills.
- Strong analytical and problem-solving capabilities.
- Ability to work independently and collaboratively in a fast-paced, dynamic environment.
- Strong leadership, collaboration, communication (both verbal and written), and problem-solving skills are integral to this position.
Key Success Factors:
- Entrepreneurial spirit with a passion for building, learning, and evolving with the team.
- Highly organized and detail-oriented with a commitment to delivering quality results.
- Demonstrated record of intellectual curiosity, innovation, and creative problem-solving with an entrepreneurial mindset.
- Ability to lead fast-paced projects with a strong sense of urgency to achieve high-quality outcomes.
- Evidence of practical 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 adapt to change.
- Emphasis on self-motivation and the ability to work independently.
Additional 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.
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Cambridge, Massachusetts, United States Alkeus Pharmaceuticals, Inc. Full timeAbout Alkeus PharmaceuticalsAlkeus Pharmaceuticals, Inc. is a pioneering biopharmaceutical firm focused on developing groundbreaking therapies for serious eye diseases that can lead to vision loss. Our flagship compound, gildeuretinol (ALK-001), is an oral investigational medication aimed at treating Stargardt disease (STGD) and Geographic Atrophy (GA)...
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Cambridge, Massachusetts, United States Alkeus Pharmaceuticals, Inc. Full timeAbout Alkeus PharmaceuticalsAlkeus Pharmaceuticals, Inc. is a late-stage biopharmaceutical organization dedicated to developing groundbreaking therapies aimed at treating severe, progressive ocular diseases that can result in vision loss. Our primary investigational compound, gildeuretinol (ALK-001), is an oral medication currently being explored for its...
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