Join our team in a dynamic hybrid role, offering flexibility to work remotely and from our headquarters in Watertown, MA. 

COMPANY OVERVIEW:

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.

POSITION OVERVIEW:

Disc Medicine is hiring a new Director, GMP Quality Assurance Biologics due to the fast growth of the company’s portfolio. The successful candidate will serve as the primary Quality Assurance representative for Disc Medicine’s Biologics pipeline including combination product development, manufacturing and disposition.  This role will provide strategic and hands-on QA oversight for Disc Medicine’s late-stage clinical trials via support of technology and method transfer, clinical manufacturing and batch disposition.  Reporting to the Executive Director, GMP Quality Assurance, Biologics, this position will have broad exposure within Quality and CMC teams providing cross-functional experience in leading initiatives and processes with meaningful opportunities for professional development and career growth.

RESPONSIBILITIES:

• Provide quality partnership and oversight of Disc Medicine’s Biologics manufacturing, testing and disposition of products (Biologics) and combination products (Biologic + Device) processes.  Experience with prefilled syringes (PFS) and safety device assembly is required.
• Support ongoing technology transfer of drug product and device manufacturing processes and analytical methods to Disc Medicine’s external CDMO’s, including ensuring late-stage GMP requirements to support pivotal clinical trials.
• Ensure compliance in Disc Medicine Quality Management System and CDMO manufacturing and testing operations with applicable GMP regulations: FDA (21 CFR Parts 4, 210, 211, 820), EU Eudralex GMP, including Annex 1 as well as ICH Guidance and applicable ISO 13485 Standards, FDA Quality Management System Regulation (QMSR), MDR 2017/745, Medical Device Regulation.  Experience with Japanese regulatory requirements beneficial. 
• Collaborate with cross-functional teams to draft, review and verify documents to Health Authority CMC submissions for assigned projects and products including verification of documents, records, protocols, reports, and data.
• Develop, implement and approve risk-based quality system oversight related to CDMO manufacturing and testing of Disc Medicine combination products including deviations, investigations, change controls and CAPA both internally and externally.
• Partner closely with internal stakeholders of Drug Product Manufacturing, Analytical Testing, Quality Control, Regulatory CMC, Clinical Operations and Supply Chain to ensure program alignment and timely delivery of quality milestones.
• Identify and escalate quality risks while driving effective, compliant resolutions while fostering the development and refinement of a quality culture in a fast-paced, matrixed environment.

 REQUIREMENTS:

• Bachelor’s Degree in a scientific discipline or related scientific field.   
• Years of Experience: 12-15 years of progressive Quality Assurance experience, with experience in Technology Transfer, Global Quality Management System design and implementation and experience in managing combination products (prefilled syringes required).
• Hands on expertise with Combination Products (Device and Biologic) including the ability to develop business and QMS processes, procedures that guide manufacturing, QC testing, and supply chain from an operational and quality perspective.
• Proven track record for building Quality culture with direct experience in supporting GMP operations; including but not limited to quality agreement negotiations, vendor management, complex investigations, GMP change management, and inspection readiness.
• Proven track record for working on CMC, development program, quality management review, and vendor joint steering committees is required.
• Demonstrated experience in all aspects of clinical development of biologics is desirable (Pre-Clinical, IND, Phase 1, Phase 2, Phase 3 and Licensure); development of quality strategy and direct discussions with the applicable Health Authorities are key expectations and requirements of the position.
• Candidates should be self-driven, extraordinarily organized, and have an established track record for building effective working relationships across a range of stakeholder groups.
• Candidates should have the ability to convey complex issues, risks, solutions, and decisions succinctly
• Ability to travel nationally and internationally (10-20%)

Disc Medicine is an equal-opportunity employer committed to providing all qualified candidates and employees equal opportunities. We offer comprehensive benefits and competitive compensation packages. The Company headquarters are in Watertown, MA, and we provide a flexible work environment. 

Disc Medicine actively recruits individuals with an entrepreneurial spirit and a drive for excellence. Interested candidates should submit a cover letter and resume to be considered for current and future opportunities.