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
Construction Manager overseeing the construction of homes with Lennar, ensuring quality control and cost management. Responsible for scheduling, trade partner supervision, and compliance with building codes.
ERP Accountmanager driving growth for Business Central portfolio at Savaco. Actively prospecting, advising customers, and closing deals while collaborating with teams.
Manager of Global Corporate Actions at Fidelity providing production support and driving operational excellence. Collaborating with cross - functional teams to ensure compliance and efficiency.
Claims Manager overseeing casualty and specialty professional claims for Hamilton, a global insurance company. Responsible for managing claims processes, leading a team, and ensuring compliance with corporate guidelines.
Technical Service Team Leader managing a national team of engineers at InPost UK. Overseeing technical solutions for complex challenges in the delivery logistics industry.
Senior Manager providing independent assessment of credit quality and emerging risks at Capital One. Leading testing and reviews within commercial portfolios across various sectors.
Business Analysis Manager at Capital One focusing on optimizing inbound channels. Leading product level modeling and developing strategies to enhance customer experience and business outcomes.
Store Manager responsible for leading new store opening and driving sales through team motivation and customer engagement. Working with a renowned women's fashion manufacturer, RABE Fashion Group headquartered in Bad Harzburg.