Quality Assurance Operations Lead

1 week ago

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

About Alkeus Pharmaceuticals

Alkeus Pharmaceuticals, Inc. is a biopharmaceutical company in the late stages of development, focused on creating transformative therapies for serious eye diseases that can lead to vision loss. Our primary investigational compound, gildeuretinol (ALK-001), is an oral medication being developed 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 the successful development and introduction of innovative therapies aimed at fulfilling unmet medical needs. This position will oversee GMP Quality Management System (QMS) activities and ensure compliance in the manufacturing, testing, and distribution of small molecule drugs, while also supporting the transition to commercial drug product manufacturing and distribution. The ideal candidate will possess extensive operational QA experience within a GMP and GDP environment, contributing to our dynamic and collaborative workplace.

Key Responsibilities

  • Manage the disposition of small molecule Drug Substance (API), Bulk Drug Product, and Finished Drug Product for release to further processing or distribution.
  • Review and assess CDMO batch records, Certificates of Analysis (CoA), and Certificates of Conformance to confirm compliance with relevant specifications, regulations, and guidelines.
  • Evaluate and approve 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 to completion for Deviations, CAPA, Change Control, etc., in partnership with Alkeus CMC and Supply Chain, and in collaboration with CDMOs/CMOs/Labs.
  • Support investigations and resolutions for Out of Specification (OOS) and Out of Trend (OOT) results in collaboration with the Alkeus CMC group and CDMOs/CMOs/Labs.
  • Develop GMP Governing Documents, including Policies, SOPs, Work Instructions, Templates, and Forms.
  • 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

  • Lead the QA operations function within the organization.
  • Formulate and implement quality strategies, including the transition from clinical to commercial manufacturing and distribution.
  • Develop expertise in 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 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 role 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 Quality Control (QC) will be beneficial for this role.
  • Exceptional leadership, communication, and interpersonal skills.
  • Strong analytical and problem-solving capabilities.
  • Able to work independently and collaboratively in a fast-paced, dynamic environment.
  • Strong leadership, collaboration, communication (both verbal and written), and problem-solving skills are critical for this position.

Additional Attributes for Success

  • 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 intellectual curiosity, innovation, and creative problem-solving abilities.
  • Ability to lead fast-paced projects with a strong sense of urgency to achieve excellence.
  • Evidence of hands-on experience and expertise.
  • Proven track record as a collaborative team player in small working environments.
  • High levels of professionalism, confidence, personal values, and ethical standards.
  • Ability to manage ambiguity and adapt to change.
  • Self-motivated with the capacity to work independently.

Travel Requirements

Occasional travel, both domestic and international, 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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