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Senior Manager/ Associate Director, GMP Quality Assurance

Cambridge, MA

Alkeus Pharmaceuticals, Inc. is a clinical-stage biotech company focused on the development of innovative therapies to treat serious diseases of the eye with high unmet need. Based in Cambridge, Mass., Alkeus was founded in 2010, and since that time has been developing its lead compound, gildeuretinol acetate (ALK-001). Designated as a breakthrough therapy and granted orphan drug status by the U.S. Food and Drug Administration, gildeuretinol is being evaluated in multiple clinical trials for the treatment of Stargardt disease and geographic atrophy (GA) secondary to age-related macular degeneration (AMD), a leading cause of blindness in the U.S.

Position Summary:

Working in a virtual pharmaceutical company, as a Sr. Manager/ Associate Director of QA GMP you will ensure compliance with Health Authority regulations and industry standards. You will be responsible for managing the GXP vendor audit and oversight program including planning and performing, as needed, external and internal GMP/GLP audits and gap assessments. Further, you will directly provide GXP Quality project management support across functional areas. You will manage deviations, CAPA resolution and GMP Change Control in the eQMS and directly support QA disposition and oversight over clinical and commercial drug substances and products, including packaging and labeling. You will assist in developing procedures for commercial manufacturing and distribution, and you will play a role in preparing for and supporting Health Authority inspections.  If you enjoy being on a small, versatile team in a dynamic environment and having visible impact, you will thrive in this role.

Primary Responsibilities:

  • Ensure compliance with FDA regulations and other relevant industry standards for clinical and commercial drug substance and IMP/Drug products
  • Manage the GXP (GMP/GLP/GCP/GVP/GDP) vendor qualification and audit program, performing QA oversight and monitoring of GMP vendors including drafting of Quality Technical Agreements, when needed
  • Support internal and external GMP audits and Health Authority inspections (US FDA, for example)
  • Provide project management support for GXP Quality functions and processes
  • Develop procedures and processes for commercial manufacturing and distribution
  • Support the development and authoring of GMP Governing Documents (Policies, SOPs, Templates, Forms, Protocols, etc.)
  • Support Deviations, CAPA resolution, and Change Control management in a Virtual Company setting
  • Support review of CMO batch records, CoAs, and CoCs to disposition clinical and commercial API and IMP/Drug Product
  • Lead product investigations and resolution in partnership with the CMC group and with CMOs
  • Manage upload and approval of GXP documents to the electronic quality management system (eQMS)
  • Support packaging, labeling and distribution of clinical and commercial product
  • Support the GMP QA function and cross functional GXP teams at Alkeus
  • Represent GMP quality in internal meetings and external meetings with CMOs
  • Lead the GXP audit program and evaluate, schedule and perform system audits. Where necessary manage contractors to perform external audits
  • Lead communications with established vendors in support vendor management and audit programs
  • Assist in the assessment and onboarding of new vendors to support various GXP processes
  • Support GXP Quality project management across functional areas
  • Interface regularly with the eQMS
  • Develop and implement quality improvement strategies
  • Deliver on other related projects as assigned

Qualifications

  • Education and Certification:
    • A bachelor's or associate degree in the life sciences or related field
    • Certification in Quality Management, Auditing, Six Sigma, etc. is a plus
  • Work Experience:
    • Ten years or more of applicable clinical and commercial GMP QA experience in the pharmaceutical industry, with small molecule experience in a virtual company setting a strong plus
    • Product development and manufacturing/disposition of clinical and commercial API and drug product
    • Experienced in managing and supporting QMS core functions, such as Deviations, CAPA, Change Control, and Product Complaints
    • Project management for QA deliverables across product development and supply chain
    • Interpreting and meeting EMA and ex-USA regulations and guidance for clinical drug manufacturing, importation, QP release, and distribution
    • Experience with GMP field alerts and product recall procedures
    • Use of Smartsheet for the effective management and tracking of projects and deliverables is a strong plus
  • Skills and Key Success Factors: 
    • Direct experience in managing GMP QA in a Virtual Company environment
    • Experience in transitioning a virtual company from clinical to commercial
    • Strong leadership, communication, and problem-solving skills are vital for this position
    • Occasional travel to manufacturing or testing sites may be required
    • This role involves maintaining high standards of quality, ensuring regulatory compliance, and driving continuous improvement in pharmaceutical QA operations
    • Experience in GMP QC or analytical development for small molecules is a strong plus for this role
    • 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
    • Excellent verbal and written communication skills, with experience translating complex concepts for various audiences
    • 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

Other Relevant Information:

  • Travel: Able to travel domestically and internationally up to 20% of time on an as-need basis
  • Others: Able to participate in scheduled off-hour meeting with US-Based and international CMOs, and Testing Labs, as needed

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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