Director, Research Quality Assurance

Disc Medicine - Massachusetts, MA

Full-time - Senior

Hybrid - Massachusetts, MA

Chemical Manufacturing

About the position

Join our team in a dynamic hybrid role, offering flexibility to work remotely and from our headquarters in Watertown, MA. Reporting to the Senior Director, Research Quality Assurance, the Associate Director/ 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 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 Associate Director/ Director of RQA will act as a subject matter expert within the department and for internal/ external business partners and operational groups within Disc Medicine and provide compliance management and quality oversight to external CROs and other GxP vendors. The successful candidate must be capable of formally/informally influencing, leading, and guiding both internal departments and external vendors through collaborative relationship building.

Responsibilities

• Maintain a high level of awareness and expertise in global 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 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.
• May lead or oversee GCP/GVP/GLP audits across multiple Disc Programs of Investigator Sites and third parties both domestic and international.
• Assure the integrity and quality of study data by independently managing, leading, participating, and following up on audits for assigned program(s).
• Lead pre-audit meeting with internal stakeholders to determine current audit status and review pre-audit documentation.
• Define and approve audit agendas, focusing on high-risk areas.
• Oversee, prepare and/or approve audit reports, and ensure distribution to internal and external parties.
• Escalate critical non-compliances /potential risks to Senior Director, RQA and/or SVP, Quality Assurance.
• Debrief internal and external stakeholders.
• Oversee and manage audit responses, including assessing whether response meets regulatory and local authorities and Disc requirements.
• Track, manage and oversee corrective and preventative actions (CAPAs), and as applicable effectiveness checks to completion.
• Track GCP/GVP/GLP compliance status and trending metrics.
• Provide 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 matters.
• 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, including quality review of regulated documents (i.e., Investigator Drug Brochures, Clinical Study Reports, Protocols, etc.).
• 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 10+ years of relevant experience, or an advanced degree and 7+ 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.

Benefits

• Comprehensive benefits and competitive compensation packages.
• Flexible work environment.