What are the responsibilities and job description for the Executive Director, GMP Quality Assurance Biologics position at Disc Medicine?
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:
The Executive Director of GMP Quality Assurance, Biologics, position is critical to enable the rapidly growing company portfolio. This role reports to the Senior Vice President of Quality and serves as the Quality leader for Disc's biologics programs. This position has visibility to the development teams, CMC teams, and executive leadership with meaningful opportunities for professional development and career growth
RESPONSIBILITIES:
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.
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:
The Executive Director of GMP Quality Assurance, Biologics, position is critical to enable the rapidly growing company portfolio. This role reports to the Senior Vice President of Quality and serves as the Quality leader for Disc's biologics programs. This position has visibility to the development teams, CMC teams, and executive leadership with meaningful opportunities for professional development and career growth
RESPONSIBILITIES:
- Setting quality strategy and driving Quality deliverables to ensure phase appropriate cGMP manufacture, testing, and supply for Disc's biologics programs.
- Represent Quality on CMC, development program, and cross functional leadership teams internal to Disc and third party GMP vendors.
- Ensure compliance oversight of manufacturing, analytical, and supply chain operations at external vendors, including establishing quality agreements, guiding investigations, CAPAs, deviations, change controls, and ensuring inspection readiness.
- Review of analytical control strategies to support programs from IND through commercialization, including but not limited to method lifecycle management, critical reagents and reference standards program, ICH stability program, specifications, and data trending oversight.
- Collaborate with Quality, internal, external Disc Medicine stakeholders to make science-driven, phase-appropriate, risk-based decisions, and proactively identify gaps and design mitigation strategies.
- Application of in-depth knowledge and understanding of current, applicable US and ex-US regulations/guidelines for biologics products.
- Foster a positive workplace culture that prioritizes collaboration, ensures accountability, and a commitment to continuous improvement.
- 20-30% travel required
- Perform any other business need identified by their manager
- BA/BS required; advanced degree a plus
- >15 years of applicable GMP quality operations experience required unless candidate has advanced degrees/certification
- Proven track record for building Quality culture with direct experience in supporting GMP operations in biologics; including but not limited to quality agreement negotiations, vendor management, complex investigations, GMP change management, and inspection readiness, and leading pre-approval inspections.
- Demonstrated experience with development of business processes, procedures that guide manufacturing, QC testing, and supply chain from an operational and quality perspective.
- 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
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.
