Associate Director/Director, GMP Quality Assurance

About the role:

The Associate Director/Director, GMP Quality Assurance is responsible for leading the Company’s GMP Quality Assurance team, ensuring that the highest standards are met for all clinical and commercial products. Reporting to the Head of Quality, this leader will also be responsible for building the Quality culture within IDRx team.  This role involves strategic planning, implementation of GMP quality systems and ensuring compliance with all regulatory requirements (e.g., FDA, EMA). This role is also accountable for ensuring that GMP vendors are compliant with global regulations, prepared for potential Regulatory Audits and Inspections and that the appropriate processes, systems, and activities are in place and performed to protect product quality, patients, and data integrity. The leader will work closely with cross-functional teams to support product development, manufacturing, and distribution, ensuring that quality is integrated throughout the product lifecycle and throughout IDRx.  The ideal candidate will have demonstrated leadership experience.

The broader IDRx team works primarily remotely and meets in-person in Cambridge, MA once monthly. Opportunities for more frequent in-person collaboration and engagement are possible and are driven by individual interest and availability.

Responsibilities:

• Develops and implements the Company’s GMP quality strategy and objectives in alignment with its mission and regulatory requirements
• Ensures all clinical and commercial products comply with relevant regulatory standards. Stays abreast of changes in regulations and guidance, adjusting quality systems, as necessary
• Oversees the development, implementation, and maintenance of GMP quality systems, including document control, change control, CAPA, risk management, and audit programs
• Oversees GMP related quality investigations, including input and approval of plans for resolution of product-impacting quality issues; provides oversight of appropriate CAPAs associated with deviations and investigations
• Leads complex GMP related quality investigations, including input and approval of plans for resolution of product-impacting quality issues; provides oversight of appropriate CAPAs associated with deviations and investigations
• Develops a risk-based GMP audit program; oversees and conducts (where applicable) GMP audits
• Ensures the timely release of clinical and commercial batches, oversees the review and approval of all GMP related documentation, and ensuring compliance with specifications and regulatory requirements
• Acts as the primary GMP quality contact for regulatory agencies, and oversees the preparation and submission of required documents
• Oversees the quality aspects of supplier and contract manufacturing organization (CMO) qualification and ongoing performance evaluation
• Implements process improvements and quality best practices
• Works closely with Clinical and Commercial Operations, Regulatory Affairs, and other departments to integrate quality into all aspects of product development and supply chain
• Advise Company's the Head of Quality on the implications and risks related to key GMP Quality issues and important strategic decisions, on a timely basis

Qualifications:

• Bachelors or Masters in a scientific/technical discipline and 10+ years of experience in the pharmaceutical/biotechnology industry, with at least 5 years in leadership roles within Quality Assurance / Quality Control.
• Experience in managing quality at GMP contracting companies.
• In-depth knowledge of FDA, EMA, and other regulatory standards.
• Strong leadership, communication, and interpersonal skills.
• Demonstrated ability in setting successful quality strategies, building and leading the function within the company.
• Virtual small company / pre-commercial to commercialization stage experience desirable.
• Demonstrated ability to think strategically and execute tactically.
• Experience with small molecule pharmaceuticals, covering both clinical and commercial stages, is highly desirable.
• Develop proactive and phase appropriate approaches and provide strategic direction to implement quality standards and procedures.
• Ability to thrive within a small organization where both leading and conducting work is required.
• Effective leader of others and ability to mentor and develop team members.
• Proven experience in leading successful regulatory inspections and GMP audits.
• Strong analytical and problem-solving skills.
• Effective written and verbal communication skills.
• Ability to travel when required (including international).