VP, Global Quality - Development and Manufacturing

PCI Pharma Services•Bedford, NH

About The Position

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. The VP Global Quality, Development and Manufacturing (D&M) is the functional head of the segment overseeing quality assurance, regulatory, quality control and managing the total compliance function for D&M. The role is responsible for ensuring compliance with established company quality policies, practices, standard operating procedures and federal regulations. They must monitor and uphold strong GxP compliance levels across PCI Pharma Services D&M facilities to ensure that the necessary regulatory practices are in place. This ensures that we produce, package and store medicinal products that have all the expected attributes of quality, safety and efficacy. The role must deliver quality excellence in all aspects of company operations and ensure compliance with the highest international standards of Good Manufacturing Practices, including but not limited to those required in the USA, EU and ROW. The incumbent must be a leading adviser on all matters of Quality and Regulatory strategy and tactics for sterile formulation, filling, and packaging.

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.
Strong proven partnership with Operations and Business Development.
50% travel required.

Nice To Haves

Medical device experience is a plus.
Cross functional background is a plus.

Responsibilities

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.