Title:  Manager, Quality Programs

Job Summary

Responsible for standardizing and implementing best in class quality processes and a “Continuous Improvement” culture across West. Working at a global level, the role will drive accountability within Quality for operational and quality excellence, continuous improvement and lead strategic quality programs. The role is responsible for contributing to the development and implementation of the quality assurance strategy for West, Contract Manufacturing and will report directly to the Sr. Director, Quality Assurance.

Essential Duties and Responsibilities

• Support development of quality strategy and launch/ maintain related quality programs for West, Contract Manufacturing.
• Lead the initiative to standardizing and implementing best in class quality processes between multiple sites. Identify best practices and ensure roll out to relevant sites
• Must have experience of working in a high volume, highly regulated manufacturing operation, ideally in the Medical Device, Pharmaceutical or technological industry sectors
• Must have the ability to manage cross functional teams on a project (rather than direct reporting line) basis
• 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 that programs are introduced into the company in a manner that is compliant with the appropriate regulatory requirements and consistent with West quality system (e.g. approaches to validation).
• Coaching / development of the employees using development and retention plans as appropriate.
• Lead complex, strategic quality programs that are cross-functional and can include managing a number of related projects to ensure coordinated execution.
• 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, developing success metrics to measure project performance and alignment with quality team mission and goals.
• Provide leadership and direction to project leads. Co-ordinate interactions ensure timely and optimal execution of quality projects and effective collaboration with key stakeholders.
• Responsible for identifying and implementing best in class quality processes
• Lead the development and oversight of Quality Improvement Plans to improve key Quality Metrics
• Influence/ Motivate all Quality team members to identify opportunities and apply Lean, Continuous Improvements and Six Sigma philosophies.
• Interface with all West sites with respect to 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.

Education

• Bachelor's Degree in Engineering/Quality/Science or equivalent experience required

Work Experience

• 5+ years of experience working in Quality 
• Pharmaceutical/Medical Device manufacturer, or experience with medical devices preferred

Preferred Knowledge, Skills and Abilities

•    Thorough understanding of Quality Systems / CFRs e.g.  ISO 13485, 21 CFR 820, 21 CFR 210 & 211 & Part 4, EU GMP
•    Must be comfortable with a rapidly-changing environment with a goal-oriented approach
•    Must have excellent communication skills both oral and written
•    Ideally Lean/Six Sigma background in a Quality setting (e.g. Certified “Greenbelt”)
•    Knowledge of and experience of a QMS which meets the legislative requirement of human medicines in the EU and USA 
•    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
•    Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description #LI-JJ1

Travel Requirements

Physical Requirements