Director of Quality Assurance Operations
1 week ago
About Alkeus Pharmaceuticals
Alkeus Pharmaceuticals, Inc. is a pioneering biopharmaceutical organization focused on developing innovative therapies for serious eye diseases that can lead to vision loss. Our primary investigational compound, gildeuretinol (ALK-001), is an oral medication being explored for the treatment of Stargardt disease (STGD) and Geographic Atrophy (GA) associated with dry age-related macular degeneration. For more information, please visit our website.
Position Overview
The Associate Director of Quality Assurance Operations plays a crucial role in facilitating the effective development and introduction of groundbreaking therapies to meet critical medical needs. This position will oversee the GMP Quality Management System (QMS) activities and ensure compliance throughout the manufacturing, testing, and distribution of a small molecule drug, while also supporting the transition to commercial production and distribution.
Key Responsibilities
- Manage the release process for small molecule Drug Substance (API), Bulk Drug Product, and Finished Drug Product for further processing or distribution.
- Evaluate CDMO batch records, Certificates of Analysis (CoA), and Certificates of Conformance to confirm adherence to 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 teams at CDMOs and Contract Labs, to identify and mitigate risks while ensuring quality and GMP compliance throughout the product lifecycle.
- Initiate and lead QMS processes 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 conjunction 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:
- Oversee the QA operations function within the organization.
- Formulate and implement quality strategies for the transition from clinical to commercial manufacturing and distribution.
- Gain proficiency with the electronic quality management system (eQMS) and provide guidance to others in its application.
- Support the development of the QA organization.
- Prepare for FDA inspections related to GMP processes and activities.
- This role requires 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.
- 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 a significant advantage.
- Comprehensive knowledge of FDA regulatory requirements and industry standards for GMP and GDP.
- Experience with virtual operations and quality oversight of remote vendors (CDMOs, QC Labs, Distributors, etc.) is essential.
- Prior experience in qualifying GMP facilities and equipment, as well as validating Drug Substance and Drug Product, is highly desirable.
- Experience in QC will be a valuable asset for this position.
- Exceptional leadership, communication, and interpersonal skills.
- Strong analytical and problem-solving capabilities.
- Able to work independently and collaboratively in a dynamic, fast-paced environment.
- Strong leadership, collaboration, communication (both verbal and written), and problem-solving skills are critical for this role.
Key Success Factors:
- Entrepreneurial spirit with a commitment to building, learning, and evolving with the team.
- Highly organized and detail-oriented with a focus on delivering quality results.
- Demonstrated history of intellectual curiosity, innovation, and creative problem-solving.
- Ability to lead fast-paced projects with a strong sense of urgency to achieve high-quality outcomes.
- Evidence of practical experience and expertise.
- Proven track record as a collaborative team player in small working environments.
- Exemplary professionalism, confidence, personal values, and ethical standards.
- Ability to manage ambiguity and adapt to change.
- Self-motivated with the capacity to work independently.
Additional Information
Travel: Occasional domestic or international travel may be necessary.
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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