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