VP, Global Quality – Development and Manufacturing

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