Vice President of Quality Assurance & Quality Control

Vice President of QA & QC

Glendale Heights, IL

I’m partnering exclusively with a growing Pharmaceutical Company looking to bring on a Vice President of Quality to lead its entire site Quality organisation, reporting directly to the CEO.

This is a senior, high-impact leadership opportunity for an established Quality executive to shape the site's Quality strategy, strengthen regulatory compliance and build a scalable Quality organisation as the business enters its next phase of growth and investment.

The successful individual will have oversight of both Quality Assurance and Quality Control, with significant influence across manufacturing operations, regulatory affairs, product development and wider business strategy. This is an opportunity to take genuine ownership of the Quality function, work closely with executive leadership and help drive the business forward while maintaining the highest standards of product quality and patient safety.

Key areas of responsibility:

• Set the overall Quality vision, objectives and priorities for the site, leading both QA and QC and ensuring the function supports business growth, operational performance and regulatory compliance.
• Act as the senior Quality representative to the FDA, leading inspections, maintaining inspection readiness, managing regulatory responses and overseeing sustainable remediation where required.
• Own the effectiveness and continuous improvement of the site QMS, ensuring systems remain robust, risk-based and aligned with evolving regulatory expectations.
• Provide executive oversight of batch release, deviations, investigations, CAPAs, change control, complaints, supplier quality, document control and data integrity, maintaining appropriate independent Quality decision-making.
• Oversee analytical and microbiological testing, OOS investigations, stability programmes, laboratory systems, environmental monitoring and associated compliance requirements.
• Partner with Manufacturing, Operations, Regulatory Affairs, R&D and Engineering to provide Quality oversight across product development, technology transfer, validation, commercial manufacturing and post-market activities.
• Establish meaningful Quality metrics, lead management reviews and use trend analysis, root-cause investigations and risk-based decision-making to address systemic issues and improve site performance.
• Build, lead and develop a high-performing Quality organisation, establishing the appropriate structure, technical capabilities, succession planning and resources to support the site's future needs.
• Work directly with the CEO and wider leadership team, translating complex regulatory requirements and Quality risks into practical business decisions while protecting compliance and patient safety.

Qualifications & Experience

• 12+ years of progressive experience within pharmaceutical manufacturing, with substantial Quality leadership experience in sterile pharmaceutical products.
• Proven executive-level leadership across multidisciplinary Quality organisations, ideally with responsibility for both QA and QC.
• A strong track record of leading FDA inspections, managing regulatory interactions and driving successful inspection readiness and remediation programmes.
• In-depth knowledge of US pharmaceutical cGMP requirements, particularly 21 CFR Parts 210 and 211, with familiarity with relevant medical device regulations.
• Broad expertise across QMS, CAPA, validation and qualification, laboratory operations, supplier quality, complaints, risk management and data integrity.
• Experience supporting products throughout the lifecycle, from development and regulatory submissions through commercial manufacturing, release and post-market activities.
• Demonstrated success building Quality teams, developing future leaders and embedding a culture of accountability, compliance and continuous improvement.
• The ability to operate as a strategic business partner to executive leadership while maintaining the independence and authority required of the Quality function.

A bachelor's degree in a relevant scientific or technical discipline is required. An advanced degree and experience implementing electronic Quality Management Systems, such as TrackWise or MasterControl, would be advantageous.

This is an opportunity to join an established pharmaceutical manufacturing business at an important stage in its development, with the mandate to lead the Quality function, influence site-wide strategy and help build the infrastructure needed to support continued growth.