Associate Director, Quality Assurance Vendor Management

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:

Disc Medicine is hiring a new Associate Director, Quality Assurance Vendor Managment due to the fast growth of the company's portfolio. The successful candidate will serve as the primary manager of the vendor/Contract Service Provider qualification and audit program in all areas of GxP (GMP, GCP, GVP, GLP). Reporting to the Director of Quality Systems and Compliance, this position will have visibility to the development teams and executive leadership with meaningful opportunities for professional development and career growth.

RESPONSIBILITIES:

• Manage the GxP External Audit Program, including but not limited to:
• Scheduling audits
• Maintaining approved Contract Service Provider lists
• Managing contracts for consultant auditors
• Performing GCP, GMP, GLP, GVP audits as experience permits
• Compiling and monitoring Contract Service Provider key performance indicators (KPIs)
• Ensure a risk-based approach to overall vendor management
• Responsible for the Internal Audit and coordination of the External Audit processes to ensure all Disc's processes and systems comply with internal policies and procedures, as well as applicable US and international regulations, laws, and guidelines
• Manage and execute the internal audit strategy and schedule with cross-functional team, including Quality and key stakeholders
• Lead and/or coordinate the planning, execution, risk mitigation and close-out of internal audits
• Collaborate with and coach internal auditees and Quality partners (IT, Clinical, CMC, Supply Chain, Development, etc.) for internal audit observations; ensure auditees deliver appropriate CAPAs and monitor through to closure
• Monitor, update, and report on internal audit program metrics
• Develop and manage Inspection Readiness Program for Disc Medicine
• Manage inspection logistics
• Support inspections at Contract Service Providers
• Support hosting client audits and regulatory health authority inspections
• Foster a positive workplace culture that prioritizes collaboration, ensures accountability, and a commitment to continuous improvement
  

REQUIREMENTS:

• Bachelor's degree with 10 years in a GxP Quality Assurance related field within a biotechnology, biologics, or pharmaceutical manufacturing facility, with at least 2 years conducting internal and external audits
• Working knowledge/expertise with electronic Quality Management Systems (i.e., Veeva) is a plus
• Audit Certification is highly preferred
• Experience working with CDMOs preferred
• Knowledge of domestic and international GMP and pharmaceutical regulations
• Strong knowledge of GMP, SOPs, and quality system processes
• Outstanding communication skills (verbal and written)
• Ability to manage multiple projects in a fast-paced environment
• Ability to effectively collaborate in a dynamic, cross-functional matrix environment
• Has advanced understanding of the job and applies knowledge and skills to complete a wide range of tasks
• Familiar with a variety of the field's concepts, practices, and procedures
• Requires thorough knowledge of the department and company operations, policies and procedures
• A high degree of independence
• Requires very limited supervision when acting or making decisions within existing policies and practices
• Relies on experience and judgment to plan and accomplish goal
• Strong cross-functional communication, organization, and time management
  
  

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.