VP, Global Quality - Development and Manufacturing

📋 Description

• • As the Vice President (VP) of Global Quality for Development and Manufacturing (D&M) at PCI Services Inc., you will serve as the paramount functional leader, directing all aspects of quality assurance, regulatory affairs, and quality control within the D&M segment.
• • This pivotal role is responsible for the comprehensive compliance function, ensuring adherence to all established company quality policies, practices, standard operating procedures (SOPs), and federal regulations across our global network.
• • You will be instrumental in monitoring and upholding stringent Good Practices (GxP) compliance levels across all PCI Pharma Services D&M facilities, guaranteeing that robust regulatory practices are consistently implemented and maintained.
• • Your leadership will ensure the production, packaging, and storage of medicinal products meet the highest standards of quality, safety, and efficacy, directly impacting patient well-being.
• • The VP Global Quality, D&M is expected to deliver unparalleled quality excellence in every facet of company operations, ensuring compliance with the most rigorous international standards of Good Manufacturing Practices (GMP), including those mandated by the USA, EU, and other global regulatory bodies.
• • You will act as the foremost advisor on all matters pertaining to Quality and Regulatory strategy and tactics, particularly for sterile formulation, filling, and packaging processes.
• • You will have overall responsibility for the PCI Pharma Services Quality Assurance and Regulatory Affairs program as it relates to Development and Manufacturing, devising and driving overarching quality strategic goals, objectives, and business priorities.
• • A key aspect of your role will be to maintain an up-to-date and comprehensive understanding of evolving regulatory requirements, ensuring all global sites are consistently appraised and prepared for any changes.
• • You will proactively drive quality initiatives and deliverables at a global strategic level, fostering business growth and operational excellence through a continuous improvement mindset.
• • This position involves providing oversight of Quality revenue and profitability, ensuring departmental budgets align with agreed-upon corporate financial targets.
• • You will champion the provision and delivery of training excellence to your direct reports and cross-functional colleagues, focusing on current Good Manufacturing Practices (cGMP) and best-in-class quality standards.
• • You will ensure that D&M sites are performing satisfactorily, maintaining desired quality metrics and Key Performance Indicators (KPIs) through the effective utilization of the company's Quality Management Review system and robust quality data analysis.
• • Collaborating closely with the Business Development team, you will identify and maximize revenue-generating opportunities within the Quality and Regulatory domains, providing essential support during client visits and industry conferences.
• • You will engage with internal and external subject matter experts (SMEs) as necessary to advance strategic quality initiatives and projects.
• • Your expertise will be called upon to assist in technical feasibility assessments, providing a critical basis for accurate quotations for current, potential, and future client work.
• • You will serve as a primary liaison with customers on global technical matters, including specifications, supply chain assessments, the establishment of technical agreements, and other legislative requirements.
• • Working in close partnership with site leaders and their respective teams, you will cultivate and uphold a strong quality culture aimed at maintaining the highest standards of compliance and minimizing risks to patients and customers.
• • You will be proactive in identifying and implementing quality initiatives across all sites, driving continuous improvement while maintaining a keen awareness of potential risks.
• • A critical responsibility is to identify compliance risks across all PCI D&M sites and develop and implement appropriate remediation strategies in collaboration with local site leads.
• • You will ensure permanent inspection readiness across the entire D&M segment and provide robust support for regulatory inspections, including the development and writing of comprehensive responses.
• • You will lead, develop, and strengthen the D&M Quality Group across five global sites, fostering a high-performing and cohesive team.
• • As a key member of the PCI Pharma Services D&M Leadership Team, you will contribute at the corporate strategic level, providing essential technical and managerial input on decisions impacting the commercial and technical direction of the company.
• • You will develop and implement a corporate document hierarchy designed to support the global PCI D&M business, ensuring an integrated and aligned business offering.
• • You will collaborate closely with Operations and other business units to drive enhanced customer service and improved profitability.