Careers

Vice President Quality Assurance

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 has an exciting opportunity in our Compliance team for a Vice President of Quality Assurance. Reporting to our General Counsel, the successful candidate will be responsible for the strategic development and operational management of Disc’s global quality assurance program and is accountable for the execution and administration of the GXP Quality Systems to support Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP). This role will have a particular emphasis on providing strategic and tactical leadership to the company’s Quality organization. Collaboration with a highly motivated, world-class team of scientists and professionals promises an exciting and engaging work environment for a motivated self-starter who can strategically design, build, implement, and adapt as the organization evolves. This role is accountable for ensuring that sites and vendors are compliant with global regulations, prepared for potential Sponsor Audits and Regulatory Inspections, and that the appropriate processes, systems, and activities are in place and performed to protect patient safety, product quality, and data integrity. The successful candidate will drive, promote, and embed a culture of ethics, integrity, and continuous improvement that will focus on delivering efficiencies.

RESPONSIBILITIES:

• Responsible for the strategic development and operational management of the global quality assurance program and accountable for the execution and administration of the GXP Quality Systems to support compliance in accordance with FDA, ICH, EMA regulations and guidelines and industry standards.
• Lead team to maintain and improve upon a risk-based and fit-for-purpose global Quality Management System (QMS) ensuring it is effectively and efficiently managed and continuously improved to sustain compliance with current and evolving global health authority requirements and regulations.
• Work closely with all functions and partners across the organization including manufacturing, supply chain, Regulatory Affairs, Non-Clinical, and Clinical Operations to ensure overall global quality and compliance.
• Ensuring sites and vendors are compliant with global regulations, prepared for potential Sponsor Audits and Regulatory Inspections and that the appropriate processes, systems, and activities are in place and performed to protect patient safety, product quality, and data integrity.
• Drive, promote, and embed a culture of ethics, integrity and continuous improvement that will focus on delivering efficiencies.
• Develop and implement risk-based Quality strategies for investigational and commercial materials including establishment and maintenance of phase-appropriate quality systems; proactively identify and mitigate quality risks.
• Responsible for Manufacturing, Clinical and Nonclinical quality-related activities, and requirements to enable the quality management system; planning and supervise vendor, and site audits; supporting teams during health authority inspections; and providing guidance on quality issues.
• Ensure quality metrics comply with best industry standards and practices.
• Maintain effective Quality governance, policies, and procedures, and continually improve this governance to meet evolving business and compliance needs.
• Lead Quality investigations, including input and approval of plans for resolution of product-impacting Quality issues; provide oversight of appropriate CAPAs associated with deviations and investigations.
• Ensure Technical Operations and GCP vendor activities are compliant with cGMP, FDA, ICH, EMA regulations and guidelines and industry standards.
• Stay abreast of industry developments – forthcoming regulations, guidance, best practices, etc., training, and mentoring staff on global GXP regulations and guidance.
• Manage department operating plans and budgets.
• Oversee hiring of staff as well as external consultants, training, and mentor staff.

REQUIREMENTS:

• Bachelor’s degree or higher in related Life Sciences discipline.
• 15 years of experience in pharmaceutical/biotech industry with increasing responsibilities, including 5 years leading a Quality function for development stage activities.
• Strong working knowledge of global GXP requirements, regulations, and guidance; sound judgment and commitment to ethical conduct.
• Strong working knowledge of Quality Management System (QMS) Expert knowledge of quality risk assessment and management methodologies, including successful application and risk remediation.
• Proven track record in establishing a quality organization and managing GMP/GCP Quality staff.
• Track record of delivering in a biotech start-up, fast-paced, innovative, dynamic environment while remaining flexible, proactive, resourceful, and efficient.
• Demonstrated success leading and motivating cross-functional teams and managing direct reports.
• Strong management and interpersonal/communication skills.
• Prior success in working effectively with senior scientific, medical and operations staff.

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 our Human Resources Department at careers@discmedicine.com and include the title of the position you are applying for in the subject line. 

Please note that agency phone calls or submissions will not be accepted. 

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