About the role

  • Manager, Quality Programs leading quality assurance strategy and implementing best practices across multiple sites. Driving operational excellence and continuous improvement in the pharmaceutical sector.

Responsibilities

  • Responsible for standardizing and implementing best in class quality processes and a “Continuous Improvement” culture across West
  • Drive accountability within Quality for operational and quality excellence, continuous improvement and lead strategic quality programs
  • Develop and implement the quality assurance strategy for West, Contract Manufacturing
  • Support development of quality strategy and launch/ maintain related quality programs for West, Contract Manufacturing
  • Lead the initiative to standardize and implement best in class quality processes between multiple sites
  • Identify best practices and ensure roll out to relevant sites
  • Organize and generate detailed quality information reports to show trends and the impact of process improvements
  • Work with project managers, engineering team, and platform management to develop plans to implement improvement projects
  • Communicate on a regular basis to senior QA leadership on the status of critical projects
  • Ensure programs are introduced into the company in a compliant manner with appropriate regulatory requirements
  • Coach and develop employees using development and retention plans as appropriate
  • Lead complex, strategic quality programs that are cross-functional
  • Maintain strategic alignment of quality programs across multiple sites, divisions and enterprise aligned to Global Quality Strategy
  • Investigate and define clear business problems and prioritize solutions using data-driven analytics
  • Provide leadership and direction to project leads
  • Coordinate interactions to ensure timely execution of quality projects and effective collaboration with stakeholders
  • Identify and implement best in class quality processes
  • Lead the development and oversight of Quality Improvement Plans to improve key Quality Metrics
  • Interface with all West sites for sharing of best practices
  • Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct
  • Perform additional duties at the request of the direct supervisor

Requirements

  • Bachelor's Degree in Engineering/Quality/Science or equivalent experience required
  • 5+ years of experience working in Quality Pharmaceutical/Medical Device manufacturer, or experience with medical devices preferred
  • Thorough understanding of Quality Systems / CFRs e.g. ISO 13485, 21 CFR 820, 21 CFR 210 & 211 & Part 4, EU GMP
  • Ideally Lean/Six Sigma background in a Quality setting (e.g. Certified “Greenbelt”)
  • Experience and good judgement in product safety management and quality risk management
  • Experience of regulatory inspections from either the European or US authorities
  • The ability to organize and prioritize tasks, be detail orientated and self-motivated
  • Excellent written and verbal communication skills

Benefits

  • Benefit programs that empower physical, mental, emotional and financial health
  • Opportunities for lifelong learning, growth and development
  • Community engagement and sustainability efforts

Job title

Manager, Quality Programs

Job type

Experience level

Mid levelSenior

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

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