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Senior Associate, Quality Management Systems

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:

The Sr. Associate, GXP QMS (Quality Management System) is responsible for supporting Alkeus’ GXP Quality Management system, comprising GXP document control, training program, and Core QMS processes, such as Deviations, CAPA, Change Control, and Complaints. This role will be responsible for drafting and routing of Governing Documents (Policies, SOPs, Forms, etc.) for review and approval, advise eQMS system users with directions and advice on system operation. Responsibilities include preparing for regulatory inspections and audits, conducting internal assessments to address gaps, and collaborating with cross-functional teams on quality initiatives. Experience with Dot Compliance or similar eQMS platforms is highly valued.

Primary Responsibilities:

  • This role is critical in ensuring compliance with regulatory requirements and maintaining the highest standards of quality within our organization.
  • Support the implementation, maintenance, and continuous improvement of the electronic Quality Management System (Dot Compliance eQMS). 
  • Guide and control the creation GxP documentation, ensuring accuracy, compliance, and timely updates. Format, review, and route for approval GXP Governing Documents (Policies, SOPs, Work Instructions, Forms, etc.) in collaboration with the functional department SMEs.
  • Develop, implement, and manage GxP training programs to ensure all staff are adequately trained and compliant with regulatory standards including follow-up with staff, as needed.
  • Support and assist the implementation of eQMS core processes, such as Deviations, Change Controls and Complaints.
  • Support Health Authority (FDA, EMA, etc.) inspection readiness and hosting activities in collaboration with the cross-functional team.
  • Support internal and external quality audits and readiness.
  • Ensure all quality management activities comply with relevant regulatory requirements and industry standards.
  • Perform internal assessments of documentation and training status and drive closure of any gaps identified.
  • Work closely with cross-functional teams to support quality initiatives and ensure alignment with organizational goals. 
  • Perform other duties as necessary, demonstrating flexibility and adaptability.
  • Experience with Dot Compliance or other eQMS platforms is a strong plus.

Skills and Qualifications:

  • Associate/Bachelor’s degree or a certificate in a related field (e.g., Life Sciences, Quality Management, etc.) - or equivalent experience with Pharmaceutical, Biotechnology or Medical Device Quality Systems 
  • Minimum of 3 years of experience in a GXP roles, such as Doc Control, Training, QA, QC, etc. within the pharmaceutical, biotechnology, or Medical Device industry.
  • Proficiency in electronic Quality Management Systems (eQMS) and GxP documentation control. 
  • Strong understanding of GxP regulations and guidelines. 
  • Excellent written and verbal communication skills, with the ability to write clear and effective SOPs. 
  • Strong attention to detail and organizational skills. 
  • Ability to identify issues, analyze data, and develop effective solutions. 
  • Ability to work collaboratively with cross-functional teams in a fast-paced startup environment. 
  • Quality management certifications (e.g., ASQ, Six Sigma) are a plus.
  • Extensive, hand-on experience in electronic Quality Management Systems (eQMS), GxP documentation control, GxP training management, and Standard Operating Procedure (SOP) development. 
  • Fluent in English, with proficiency in Microsoft applications (Excel, Word, SharePoint, PowerPoint).

Skills and Key Success Factors: 

  • 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.
  • 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
  • Ability and aptitude to manage ambiguity and adaptability to change
  • Emphasize the need for self-motivation and the ability to work independently

Other Relevant Information:

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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