Director, Clinical Quality Control

Discmedicine; Massachusetts; On-site; USD 198,000 - 242,000; Full time

Benefits offered by this job

Comprehensive benefits

Flexible work environment

Competitive compensation packages

Job summary

Discmedicine in Watertown, MA is seeking a Director of Clinical Quality Control to manage stability studies and ensure compliance with ICH and GMP guidelines. This role involves overseeing quality control testing and managing stability databases while leading cross-functional collaborations.

The ideal candidate will have 12–15 years of experience in the biopharmaceutical sector, excellent organizational skills, and the ability to work both independently and collaboratively. The salary range is between $198,000 and $242,000 USD.

Qualifications

• At least 12–15 years in biopharmaceutical industry with quality control leadership.
• Experience with QC OOS investigations and product stability management.
• Working knowledge of quality systems and global regulatory requirements.

Responsibilities

• Manage stability studies and protocol design for clinical programs.
• Create and approve SOPs and stability protocols.
• Oversee sourcing and management of quality control standards.

Skills

Quality control management

Regulatory compliance knowledge

Data management

Statistical analysis

Communication skills

Team leadership

Education

B.S. degree (M.S./Ph.D. preferred)

Tools

Veeva

LIMS

Smartsheet

Job description

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

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 CFR 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.

Salary Range

$198,000 – $242,000 USD

Equal Opportunity Employer

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.

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