Job Description

The VP, Quality & Regulatory Affairs is an executive leadership role responsible for defining and executing the strategic direction for both the Quality and Regulatory functions. This executive leader provides strategic and operational oversight of Quality Assurance (QA), Quality Control (QC), compliance, validation, supplier quality, and quality systems across product development, clinical manufacturing, and commercial manufacturing activities.

The VP, Quality & Regulatory Affairs partners closely with CMC, Manufacturing, Clinical Development, Supply Chain, R&D, and external partners to ensure that all products are developed and manufactured in accordance with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and applicable FDA, EMA, ICH, and other global regulations to meet the highest standards of product safety, efficacy, and compliance. Provides expertise in translating regulatory requirements into practical, workable plans. Acts as the main liaison with global health authorities. As a member of the executive leadership team, the VP, Quality & Regulatory Affairs fosters a culture of quality, continuous improvement, operational excellence, patient focus, accountability, and cross-functional collaboration to support the company's strategic objectives.

Responsibilities:

• Provide strategic leadership and advise executive management and the Board on quality, compliance, regulatory, and quality culture. Develop and execute the company's global Quality strategy aligned with corporate objectives.
• Maintain and improve a robust Quality Management System (QMS) to support product development, clinical manufacturing, and commercial operations.
• Serve as the executive leader responsible for company-wide culture of quality, compliance, and continuous improvement.
• Support corporate growth, technology transfers, new product introductions, and commercialization.
• Provide executive oversight of Quality Assurance activities, including but not limited to: Quality Systems, Document Control, Training, Change Control, Deviations, CAPA (including timely implementation and closure), Audits (internal, external and supplier), Risk Management, and Product Release
• Ensure compliance with FDA, EMA, and other global regulatory authorities.
• Lead preparation of Quality related content (specifications, stability data, etc.) for all regulatory submissions.
• Provide executive oversight of Quality Control activities including but not limited to: Analytical testing, Method Transfer, Stability programs and ensure laboratory operations comply with GMP and data integrity requirements.
• Ensure company readiness for regulatory inspections and serve as executive quality representative during FDA, EMA, and other regulatory inspections.
• Ensure quality system metrics and key process indicators are established and used to drive compliance and continuous improvement.
• Determine appropriate Quality organization structure, staffing and resource requirements to support business objectives.
• Provide mentorship to staff related to diverse regulatory requirements, practices and customs.
• Provide leadership to direct report(s) and regulatory guidance to project teams.

Skills Required:

• Extensive knowledge of global GMP regulations, FDA, EMA, ICH, and international quality standards.
• Proven ability to maintain, improve, and lead Quality Management Systems (QMS) in biotechnology or pharmaceutical environments.
• Demonstrated success leading regulatory inspections and managing regulatory compliance.
• Strong expertise in Quality Assurance, Quality Control, validation, supplier quality, and risk management.
• Experience overseeing quality activities across product development, clinical manufacturing, commercial manufacturing, and technology transfer.
• Excellent leadership skills with a track record of building, mentoring, and developing high-performing teams.
• Strategic thinker capable of aligning quality objectives with overall business goals while maintaining operational excellence.
• Strong cross-functional collaboration and stakeholder management skills, with the ability to influence executive leadership, regulatory agencies, and external partners.
• Exceptional analytical, problem-solving, and decision-making abilities in complex, highly regulated environments.
• Outstanding communication, organizational, and project management skills with a commitment to fostering a culture of quality, integrity, and continuous improvement.
• Entrepreneurial and hands-on, comfortable in small company and possesses the ability to multi-task and set priorities.
• High-energy, results-oriented leader with a strong bias for action, sound judgement, and the ability to drive execution with urgency.

Education and Experience:

• Bachelor’s degree in scientific discipline (Chemistry, Biology, biotechnology or related scientific field) or commensurate experience; advanced degree preferred.
• 15+ years of progressive relevant senior regulatory and QA/QC experience, including at least 8 years executive level experience, in the Pharma biotechnology/pharmaceutical industrywith direct regulatory affairs experience with drug/device combination products.
• Successful leadership of multiple FDA and international regulatory inspections.
• Thorough to expert knowledge of cGMP and QSR regulatory requirements.
• Knowledge of GLP, GCP, and ICH requirements.
• Experience with either the creation or major overhaul of a corporate Quality System.
• Demonstrated ability to advance products from early development through commercial launch including successful PAI. Commercial experience is a plus.
• Experience with preparation for and execution of pre-approval inspections (PAI's).
• Knowledge of 21 CFR Part 210, 211 and 820, ISO 13485, EU MDR 2017/745 and other regulatory standards related to drug-device combination products.
• Proficient written and verbal communication skills.
• Strong project management skills to manage complex regulatory project and meet deadlines.
• Regulatory certification or training preferred.
• Experience with GMP-regulated pharmaceuticals, medical devices or drug combination products is highly desirable.