POSITION OVERVIEW:

As Disc Medicine transitions from a clinical-stage organization to a commercial-stage one, the company is introducing a new role: Director of Clinical Quality Control. The successful candidate will play a crucial role in driving the company’s growth and achieving strategic objectives.

The Director of Quality Control will manage stability studies for various small-molecule and biologics programs in clinical development, ensuring compliance with ICH and GMP guidelines. The primary functions include protocol design; coordination and execution of various stability studies at CDMOs; statistical analysis; and expiration dating.  Additionally, this role will oversee the end-to-end supply of reference standards for quality control testing, including sourcing/production, qualification, inventory and distribution, as well as lifecycle monitoring. Significant contributions from this role will be essential for facilitating regulatory filings of Disc Medicine assets.

This position reports to the Head of Analytical Development and Clinical Quality Control within the Technical Operations organization at Disc Medicine. The ideal candidate should have at least 10 years of experience in quality control management in the pharmaceutical or biotech industry.

RESPONSIBILITIES:

This role will have extensive technical expertise and be responsible for stability and reference standard management for Disc Medicine’s clinical development programs. The technical responsibilities include:

• Evaluate, select, and manage CDMOs for QC stability testing.
• Direct stability studies per ICH guidance, sample pulls, and data analysis to determine retest periods and product shelf-life.
• Create, revise, and approve SOPs, stability protocols, and reports in accordance with current 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 the 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.