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Director of Quality Assurance Operations

2 months ago

Cambridge, Massachusetts, United States Alkeus Pharmaceuticals, Inc. Full time

About Alkeus Pharmaceuticals

Alkeus Pharmaceuticals, Inc. is a biopharmaceutical organization focused on developing innovative therapies for serious eye diseases that can result in vision loss. Our primary investigational compound, gildeuretinol (ALK-001), is an oral medication aimed at treating Stargardt disease (STGD) and Geographic Atrophy (GA) linked to dry age-related macular degeneration. For more details, please visit our website.

Position Overview

The Associate Director of Quality Assurance Operations plays a crucial role in ensuring the effective development and introduction of groundbreaking therapies to meet significant medical needs. This position will oversee GMP Quality Management System (QMS) activities and provide guidance on the manufacturing, testing, and distribution of small molecule drugs, facilitating the transition to commercial drug product manufacturing and distribution. The ideal candidate will possess substantial operational QA experience in a fast-paced, collaborative setting.

Key Responsibilities

  • Manage the release of small molecule Drug Substance (API), Bulk Drug Product, and Finished Drug Product for processing or distribution.
  • Evaluate CDMO batch records, Certificates of Analysis (CoA), and Certificates of Conformance to confirm 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 teams at CDMOs and Contract Labs, to identify and mitigate risks while ensuring quality and GMP compliance throughout the product lifecycle.
  • Initiate and oversee 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 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 Initiatives:

  • Lead the QA operations function within the organization.
  • Formulate and execute quality strategies, including the transition from clinical to commercial manufacturing and distribution.
  • Develop expertise in the electronic quality management system (eQMS) and guide others in its application.
  • Support the development of the QA organization.
  • Prepare for FDA inspections regarding GMP processes and activities.
  • This role requires maintaining high-quality standards, ensuring regulatory compliance, and fostering 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 a minimum of 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.
  • 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 role.
  • Exceptional leadership, communication, and interpersonal skills.
  • Strong analytical and problem-solving capabilities.
  • Able to work independently and collaboratively in a dynamic, fast-paced environment.
  • Demonstrated leadership, collaboration, communication (both verbal and written), and problem-solving skills are crucial for this position.

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.
  • Proven record of intellectual curiosity, innovation, and creative problem-solving.
  • Able to lead fast-paced projects with a strong sense of urgency to achieve high-quality outcomes.
  • Evidence of practical experience and expertise.
  • Successful track record as a collaborative team player in small working environments.
  • Exemplary professionalism, confidence, personal values, and ethical standards.
  • Adept at managing ambiguity and adapting to change.
  • Self-motivated with the ability to work independently.

Additional Information

Travel: Occasional 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.