What are the responsibilities and job description for the Senior Associate, Quality Management Systems position at Alkeus Pharmaceuticals Inc?
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 :
Skills and Key Success Factors :
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.
