Careers

Senior Director Research Quality Assurance (RQA)

POSITION OVERVIEW:

Reporting to the SVP of Quality, the Senior Director of RQA will be responsible for developing, implementing, and overseeing Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and Good Pharmacovigilance Practices (GVP) quality systems within Disc Medicine. This hands-on senior director-level role is centered on leading a risk-based audit program supporting pre-clinical, clinical, and post-approval development activities.

The position requires an expert knowledge of GCP and a good working knowledge of GLP and GVP. The Senior Director of RQA will act as a subject matter expert within the department and for client groups within Disc Medicine and provide compliance oversight to external CROs. The successful candidate must be capable of formally/informally influencing, leading, and guiding both internal departments and external vendors through collaborative relationship building. 

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.

RESPONSIBILITIES:

• Maintain a high level of awareness and expertise in international GCP/GVP/GLP regulations and lead the development of quality standards and procedures in related systems and processes for Disc Medicine.
• Collaborates with internal and external stakeholders and partners to enable and ensure appropriate implementation of the US and EU compliance requirements and associated industry guidelines as applicable to GCP/GVP/GLP.
• Ensures the successful realization of a robust and risk-based audit program by leading/conducting both internal and external audits related to GCP/GVP/GLP.
• Establish and maintain processes and tools for preparing, conducting, reporting, and following up on GCP/GVP/GLP audits.
• Provide senior management with in-depth analysis and risk management reports for compliance and quality-related matters and recommend solutions. 
• Ensure FDA inspection-readiness and serve as Quality Liaison for regulatory inspections and partner’s audits; provide post-inspection/audit support and follow up as required.
• Assist in the preparation and review of regulatory submissions for FDA and global health authorities.
• Manage contracts and day-to-day activities of external contractors as needed. 
• Develop and conduct training on current regulations and compliance issues.
• Represent Quality at project teams and discussions for GCP/GVP/GLP related issues.
• Participate in team efforts to achieve departmental and company goals.
• Work with Program Management, Clinical Operations and Drug Safety and Pharmacovigilance to build Quality related activities into timelines.
• Assure that the appropriate business processes and associated suites of documents (e.g., policy, SOPs, and Work Instructions) are in place and optimally maintained to support the above activities.

 REQUIREMENTS:

• BS or equivalent in a scientific discipline and 12+ years of relevant experience, or an advanced degree and 10+ years of relevant experience within the pharmaceutical industry, including a leadership role in Quality.
• Extensive knowledge of the pharmaceutical/biotech industry centered on FDA, EU, ICH, GCP/GVP/GLP.
• Exceptional organizational, interpersonal, and communication skills, both verbal and written, with the ability to facilitate meetings, conduct training, and 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 (some international) 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.

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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