Vice President of Quality

Role Summary

Vice President of Quality responsible for ensuring the highest quality standards, compliance, and regulatory adherence for the combination product, leading the QMS, and directing quality and CMC functions across pharmaceutical and medical device operations.

Responsibilities

• Establish and maintain a robust Quality Management System (QMS) to ensure compliance with GxP and FDA regulations (21 CFR part 4, 820, 210 & 211), ICH guidelines, ISO 13485, and other regulatory guidelines.
• Lead and manage quality assurance (QA), quality control (QC), and compliance functions for combination product operations.
• Lead preparation for and management of regulatory inspections, audits, and assessments, ensuring compliance with global guidelines (FDA, EMA, ICH).
• Lead and support Quality due diligences audits from potential and existing partners.
• Provide strategic oversight for CMC activities, ensuring robust drug and device development, lifecycle management, and post-approval planning.
• Develop a phase-appropriate CMC strategy.
• Lead quality strategy for combination product development, ensuring alignment with regulatory expectations and best practices.
• Partner with R&D, Operations and Clinical to drive quality into product development from early-stage development through commercialization.
• Collaborate with manufacturing teams to ensure quality integration throughout production processes.
• Guide and support technology transfer, process validation, and scale-up efforts, ensuring compliance with cGMP and regulatory requirements.
• Implement quality risk management strategies to mitigate compliance risks and drive continuous improvement.
• Guide Supply chain group ensuring external partners meet quality and regulatory standards.
• Build and develop a high-performing quality and regulatory teams (QA, QC, and CMC).
• Mentor and coach quality leaders and cross-functional teams to enhance technical expertise and regulatory knowledge.
• Foster a collaborative quality culture that integrates with product development and manufacturing operations.
• Influence across departments and sustain a high-performing culture.

Qualifications

• Advanced degree (PhD, MS, or MBA) in Life Sciences, Engineering, Regulatory Affairs, or related field.
• Direct experience with INDs and combination product approvals.
• Experience in late-stage clinical development and commercial product launch.
• 15+ years of Quality leadership experience in biopharmaceutical and/or combination product industry, with at least 5 years in an executive or senior leadership role.
• Proven expertise in FDA regulations and supporting IND filings, cGMP and regulatory compliance for combination products.
• Strong CMC experience, including leadership of drug and device development, validation, and manufacturing processes.
• Deep understanding of ISO 13485, 21 CFR Part 820 (devices), 21 CFR Part 4 (combination products), 21 CFR Part 210/211 (pharmaceuticals), and ICH guidelines.
• Strong leadership skills with the ability to influence and drive cross-functional collaboration in a fast-paced environment.

Skills

• Strategic Vision
• Technical Acumen in CMC
• Leadership & Influence
• Operational Excellence
• Problem-Solving & Decision-Making

Education

• Advanced degree as listed above (PhD, MS, or MBA).

Additional Requirements

• None specified beyond role content.