VP, Global Quality – Development and Manufacturing
Posted 2026-05-06
Remote, USA
Full-time
Immediate Start
- Job Description:
- Has overall responsibility for the PCI Pharma Services Quality Assurance and Regulatory Affairs programme in relation to D&M
- Devise and drive general quality strategic goals, objectives, and business priorities
- Maintain knowledge of regulatory requirements, ensuring all sites are appraised on requirements
- Proactively drive Quality initiatives and deliverables at the global strategic level to ensure business growth and excellence are maintained
- Maintain continuous improvement mindset
- Provide oversight of Quality revenue and profitability to ensure budgets are in accordance with agreed corporate targets
- Ensure the provision and delivery of training excellence to subordinates and co-workers with respect to current Good Manufacturing Practices
- Ensure the D&M sites are performing satisfactorily and maintaining desired quality metrics and KPIs via the company Quality Management Review system in relation to quality data
- Work closely with Business Development to ensure revenue earning opportunities within Quality and Regulatory are maximised, supporting the teams where required during client visits or conferences
- Works with subject matter experts (SMEs) internally and externally as required for strategic or quality initiatives
- Assists in technical feasibility assessments as a basis to provide quotations for present, potential and future work
- Liaises with customers on global technical matters e.g. specifications, supply chain assessments and establishment of technical agreements and other legislative requirements
- Works closely with the site leaders and site leadership teams to uphold a strong quality culture aimed at maintaining the highest standards of compliance and lowest risks to patients and customers
- Be proactive with quality initiatives across sites, drive continuous improvement while understanding risks
- Identify compliance risks across the PCI D&M sites and identify methods of remediation where appropriate working with local site leads
- Maintain permanent inspection readiness across the D&M segment
- Support regulatory inspections and response development and writing
- Lead, develop and strengthen the D&M Quality Group across five global sites
- Works as part of the PCI Pharma Services D&M Leadership Team at the corporate strategic level as the individual responsible for the D&M Quality function and also providing technical and managerial input on decisions relating to the commercial and technical direction of the company
- Develop and implement a corporate document hierarchy to support the global PCI D&M business, capable of delivering an integrated and aligned business offering
- Works closely with Operations and other business units to drive customer service and improved profitability
- Requirements:
- Undergraduate degree in related discipline required
- Advanced degree preferred
- 15+ years leading global teams responsible for drug product development and manufacturing quality
- 10+ years sterile formulation, filling, and packaging experience
- Must have experience working with different sterile drug formats including liquid and lyophilized vials, cartridges, and syringes
- Quality experience in North America and Europe required
- Medical device experience is a plus
- Cross functional background is a plus
- Strong proven partnership with Operations and Business Development
- 50% travel required
- Benefits:
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Professional development opportunities