PCI Pharma Services

VP, Global Quality – Development and Manufacturing

PCI Pharma Services

full-time

Posted on:

Location Type: Remote

Location: California • New Hampshire • United States

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Job Level

Lead

About the role

  • 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

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
Benefits
  • Health insurance
  • Retirement plans
  • Paid time off
  • Flexible work arrangements
  • Professional development

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
Quality AssuranceRegulatory AffairsGood Manufacturing PracticesQuality Management ReviewSterile formulationFillingPackagingTechnical feasibility assessmentsCompliance risk identificationInspection readiness
Soft skills
LeadershipStrategic planningContinuous improvementCollaborationCommunicationTraining excellencePartnershipProactivityOversightProblem-solving