Director, Clinical Quality Control

About the role

The Director of Clinical Quality Control is a dynamic hybrid role at Disc Medicine, offering flexibility to work remotely and from our headquarters in Watertown, MA.

Responsibilities

• Evaluate, select, and manage Contract Development and Manufacturing Organizations (CDMOs) for Quality Control (QC) stability testing.
• Direct stability studies per International Conference on Harmonization (ICH) guidance, sample pulls, and data analysis to determine retest periods and product shelf-life.
• Create, revise, and approve Standard Operating Procedures (SOPs), stability protocols, and reports in accordance with current Good Manufacturing Practices (GMP), ICH, and global regulatory guidelines.
• Create, implement, and manage stability databases, forecast stability testing, and report on metrics, perform data trending and statistical analysis to support expiry dating.
• Manage Quality System records for QC Stability: create, assess, review deviations, change controls, CAPAs, and other applicable stability-related investigations and events.
• Oversee the sourcing, characterization, qualification, retesting, and inventory management of primary and working reference standards.
• Author and review the stability and reference standard sessions of the global health authority dossier for clinical trials and commercial licensure.
• Support GMP audits and inspections.
• Act as the team leader to ensure alignment and effective communication among cross-functional areas, including analytical development, process development, formulation development, manufacturing, supply chain, regulatory, quality assurance, and other internal and external partners.
• Design and improve processes to ensure compliance with global regulatory requirements.
• Establish and maintain a network of external partners to fulfill technical and capacity requirements.
• Support budget planning and resource allocation to support laboratory operations and staffing.

Requirements

• A B.S. degree is required; an advanced degree (e.g., M.S./Ph.D.) in a related field is preferred.
• At least 12-15 years of experience in the biopharmaceutical industry, including prior leadership experience in quality control functions.
• Knowledge of product stability, setting of specifications, product shelf-life management, and experience with QC OOS investigations.
• Knowledge of data management tools and statistical process control, and data integrity requirements and expectations.
• Experience with Veeva, LIMS, and Smartsheet desirable.
• Knowledge of bioanalytical and analytical methods, including but not limited to LC-MS, GC-MS, UV-vis, IR/FT-IR, HPLC (SEC, icIEF), CE-SDS, ELISA, cell-based potency assays.
• Experience with method validation, method transfer, and hands-on management of day-to-day testing operations for outsourced small molecules and biologics therapeutics.
• Working knowledge of quality systems, global regulatory requirements (example: 21 CRF Part 11/210/211,820), and Guidance documents.
• Knowledge of technical writing for CMC sections of regulatory documents (IND, MAAs).
• 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 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.

Benefits

Disc Medicine offers comprehensive benefits and competitive compensation packages. The Company headquarters are in Watertown, MA, and we provide a flexible work environment.

Pay

The annual base salary range for this position is $198,000 - $242,000 USD.