Careers

Quality Assurance Manager

SUMMARY:

Disc Medicine is hiring a new Quality Assurance (QA) Manager due to the fast growth of its programs. This position is located within Disc Medicine’s Watertown, MA office, although the Company offers a flexible, hybrid work environment. The successful candidate will have direct work experience with GXP regulations within the pharmaceutical industry and be a strong team player with excellent communication skills. Reporting to the Director, QA, this position offers the chance to join a team of passionate colleagues with the opportunity for career growth.

RESPONSIBILITIES

• Timely management of batch record review and release to ensure a continuous supply of clinical trials.
• Work with CMC to manage quality at Contract Service Providers (CSPs).
• Management and maintenance of quality systems such as Training, Change Control, Deviations, CAPA, Effectiveness Checks, and Product Quality Complaints.
• Review/approve analytical methods qualification and validation and stability protocols and reports.
• Effectively multi-task to meet deadlines and commitments.
• Author and implement QA GXP standard operating procedures (SOPs).
• Develop and deliver training on GXP SOPs and systems.
• Assist in the preparation of GXP metric reports for annual review with the Senior Management team.
• Identify risks regarding quality system and vendor management. Ensure escalation of issues to appropriate management and governance forums.
• Perform CSP audits.

REQUIREMENTS

• Bachelor’s degree in a scientific discipline or equivalent experience.
• Minimum of 5 to 10 years of pharmaceutical industry experience in Quality Assurance or other relevant roles.
• Thorough knowledge of applicable GXP regulations (e.g., CFRs and ICH).
• Ability to build relationships and work collaboratively with a variety of individuals within the department, company, and external vendors.
• A strong team player with the ability to effectively communicate sound quality advice cross-functionally based on experience, regulations, and business needs.
• Ability to simultaneously handle multiple project issues while dealing with time demands, incomplete information, or unexpected events.
• Strong negotiation skills, flexibility, and ability to provide a solution-based approach to emerging challenges.
• Attention to detail and proper use of tools for information processing and electronic systems.
• Other skills and abilities as required.

About Disc Medicine

Disc Medicine is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing novel treatments for patients who suffer from serious hematologic diseases. We are building a portfolio of innovative, first-in-class therapeutic candidates that aim to address a wide spectrum of hematologic diseases by targeting fundamental biological pathways of red blood cell biology, specifically heme biosynthesis and iron homeostasis. Disc Medicine values collaboration, professional development, and scientific integrity and promotes an inclusive company culture that empowers and inspires.

Interested in joining our team? Please contact us at careers@discmedicine.com