Manager, Quality Programs
West Pharmaceutical Services
full-time
Posted on:
Location Type: Office
Location: Dublin • Ireland
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About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
quality assurancequality improvementdata-driven analyticsquality metricsregulatory compliancequality systemsLeanSix Sigmaproduct safety managementquality risk management
Soft Skills
leadershipcommunicationorganizational skillsprioritizationdetail orientationself-motivationcollaborationcoachingaccountabilitystrategic alignment
Certifications
Bachelor's Degree in EngineeringBachelor's Degree in QualityBachelor's Degree in ScienceCertified Greenbelt