Director, GMP Quality Control

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:

Reporting to the SVP of Quality, the Director of GMP Quality Control is responsible for development, implementation and oversight of late phase through commercial GMP Quality Control/Laboratory Control systems for Disc Medicine. This is hands on Director level role centered on leading a risk-based quality control/lab controls program enabling late-phase clinical and post approval development activities that are primarily outsourced.

The position requires an expert knowledge of GMP quality control testing operations, lab controls program, and analytical method lifecycle management.  This person will act as a subject matter expert within the department and for client groups within Disc Medicine, as well as providing compliance oversight to external testing and manufacturing organizations.  This person must be capable of formally/informally influencing, leading, and guiding both internal departments and external vendors through collaborative relationship building. 

RESPONSIBILITIES:

• Collaborates cross-functionally and with external partners to ensure that Quality Control business processes, systems, and analytical methods are established and maintained as fit for purpose and GMP compliant for Disc Medicine late phase and commercial programs. Works with senior stakeholders to develop plans and strategic direction for GMP testing and laboratory controls program.
• Oversees outsourced GMP QC testing of small molecule and biologics therapeutics in late phase clinical development through commercial stage, including late-stage product specification setting and stability program ownership.
• Accountable for QC out of trend and out of specification investigations; investigates, identifies root cause, and identifies CAPA for testing related issues for assigned programs.
• Approves and submits monitoring, and trend reports in support product release and stability.
• Maintains commercial reference standard and reference material program for Disc Medicine.
• Authors, reviews, or approves SOPs, qualification/validation protocols and reports, change controls, and regulatory submission related documents (INDs, MAAs) as related to Quality Control.
• Participates in regulatory inspections and audits of contract GMP testing laboratories.
• Represents Quality Control operations for Disc Medicine in regulatory inspections and partner audits.
• Maintains high level of awareness, expertise in international GMP Quality Control/Laboratory Control regulations.
• Fosters a positive workplace culture that prioritizes collaboration, ensures accountability, and a commitment to continuous improvement.

 REQUIREMENTS:

• Master’s Degree and 10+ years’ experience OR Bachelor’s degree with 12+ years of experience.
• Working knowledge of bioanalytical and analytical method validation, method transfer, and experience managing day to day testing operations for outsourced small molecule and biologics therapeutics.
• Thorough knowledge of product stability, setting of specifications, product shelf-life management, and experience with QC OOS investigations
• Working knowledge of quality systems, global regulatory requirements (example: 21 CRF Part 11/210/211,820), and Guidance documents.
• Thorough knowledge of technical writing for CMC sections of regulatory documents (IND, MAAs)
• Knowledge of data management tools and statistical process control, and data integrity requirements and expectations.
• Experience with LIMS desirable.
• Exceptional organizational, interpersonal, and communication skills, both verbal and written, with the ability to facilitate meetings, conduct training and to present information in an advisory capacity.
• Attention to detail, excellent review skills and the ability to organize and manage multiple tasks in a fast-paced environment.
• Able to travel (some international) up to 25%.
• Ability to work both independently and collaboratively with project teams and cross functionally, to build productive relationships with internal and external partners, to influence decision making and to engage in conflict resolution.

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.