The Vice President of Quality and Compliance is a strategic executive leader responsible for designing, implementing, and overseeing the company’s global Quality Assurance (QA), Quality Control (QC), and compliance programs across biologic drug-device combination products, Class III medical devices, and clinical activities. This includes monoclonal antibodies, oligonucleotides, and sterile hardware products developed and manufactured through contract development and manufacturing organizations (CDMOs), CROs, and other external partners.
This role will establish and scale a robust, phase-appropriate Quality Management System (QMS) aligned with global regulatory requirements, despite the absence of internal manufacturing or testing infrastructure. The VP will define QC oversight for externally produced pharmaceuticals and hardware received at the Ft. Lauderdale facility. As the company’s senior quality authority, this executive will drive quality culture, ensure regulatory readiness, manage inspection strategy, and serve as a key partner to R&D, Regulatory Affairs, Technical Operations, and Clinical Development.

QUALIFICATION REQUIREMENTS:

Education:

• Advanced degree in Pharmacy, Biology, Chemistry, Engineering, or a related scientific field required.

Experience:

• 15+ years of progressive leadership in Quality & Compliance within biotech or pharmaceutical environments.
• Extensive experience in monoclonal antibody and oligonucleotide product development, including CMO oversight.
• Minimum 5 years of experience managing contract manufacturing and QC functions for biological products.
• Proven success developing and scaling QMS in early to late-stage companies.
• In-depth knowledge of 21 CFR, ICH guidelines, ISO 13485, and global GxP expectations.
• Direct FDA and international inspection experience, including successful audit outcomes.
• Experience with FDA Class III medical devices preferred.
• At least 5 years in people management roles with responsibility for cross-functional teams.

Knowledge/Skill:

• Strong leadership, communication, and change management skills.
• Ability to operate effectively in a dynamic, growth-stage environment.
• Demonstrated integrity, attention to detail, and strategic thinking.
• Skilled in risk-based quality planning and executive-level reporting.

PRINCIPAL DUTIES AND RESPONSIBILITIES INCLUDE THE FOLLOWING:

The following is not intended to be an all-inclusive list of responsibilities. Other activities may be assigned as required by management.

• Develop, implement, and scale a global Quality Management System (QMS) encompassing biologics, medical devices, and clinical operations, ensuring it is phase-appropriate, harmonized, and inspection-ready.
• Set and execute the long term quality vision across the product lifecycle, from early development through commercialization.
• Serve as the primary quality lead for CMOs, CDMOs, device suppliers, and CROs, overseeing quality agreements, method transfers, batch release, deviations, validations, and audits.
• Ensure compliance with global regulations and standards, including FDA, EMA, ICH, GCP, GMP, and ISO 13485.
• Lead regulatory inspection readiness, including preparation, strategic interactions, and post-inspection follow-up and remediation.
• Manage and conduct internal and external audits across pharmaceutical, device, and clinical operations.
• Oversee and approve analytical methods, specifications, stability protocols, batch records, and release testing for externally manufactured drug products, sterile devices, and hardware.
• Establish and manage QC processes for incoming hardware and sterile device inspection and release at the Ft. Lauderdale site.
• Ensure compliance with Design Control, Risk Management, and ISO 13485 requirements for Class III medical devices.
• Provide QA oversight for clinical operations, including CROs, sites, and vendor labs, ensuring GCP compliance and resolution of audit findings through effective CAPA.
• Lead proactive risk management across the development and supply chain, including deviation investigations and CAPA execution.
• Oversee document control, SOPs, change management, training programs, and maintenance of regulatory guidance libraries.
• Monitor evolving global regulatory expectations and ensure timely integration into quality systems and practices.
• Build, lead, and mentor a high-performing Quality & Compliance team composed of internal staff and external consultants.
• Foster a culture of quality ownership, continuous improvement, and cross-functional collaboration across the organization.
• Maintain clear and effective communication channels with partner QA/QC teams to support alignment and issue resolution.
• Lead quality governance forums and represent the company in executive level discussions and strategic planning.
• Develop and manage the Quality function’s budget, aligning resources to operational and strategic needs.
• Support continuous improvement initiatives across the company’s quality and compliance functions.

SUPERVISORY RESPONSIBILITIES:

Direct reports include:

• Quality Assurance and Compliance team (internal staff and consultants)
• External QA/QC contractors supporting pharma, biologics, and device oversight