Title:  Director, Quality Programs

Job Summary

In this role, the individual will serve as a key strategic partner to successfully develop new product platforms for advanced manufacturing products as well as conduct process improvement and harmonization activities for legacy High Value Products (HVP) products in global elastomer & metal sites across value streams. The Director, Quality Programs will provide strategic direction and management oversight to the Quality functions within elastomer & metal sites which are involved in advanced manufacturing production.

This individual applies their experience, expertise, and knowledge of the pharmaceutical industry to lead, organize, direct and execute strategically identified initiatives relating to Quality programs. This role sets and aligns functional strategies and objectives to the overall business strategy on a continuous basis in order to achieve objectives in support of the West Global Elastomers & Primary Containment vision, strategic direction and metrics. This role partners with the Global Engineering team as well as Product Management, Regulatory, R&D and other Quality functions to ensure quality controls and product requirements are compliant with regulatory, and business requirements / customer expectations throughout the product life cycle.

Essential Duties and Responsibilities

• The primary responsibility for this role is to collaborate with Elastomers & Primary Containment Leadership in driving global harmonization and enhancement of advanced manufacturing processes and product quality. This entails identifying best practice solutions, harmonize the processes, implement the processes and ensure sustainment of these processes
• Lead the identification of risks and opportunities for improvements regarding elastomers & metal production processes and quality controls across all adavanced manufacturing sites and work with all levels within the organization including SMEs in leading, establishing and executing a strategy for improvement
• Evaluate existing Quality processes to identify discrepancies and areas for harmonization
• Conduct thorough analysis to understand the impact of different practices
• Create and execute implementation plans for transitioning to harmonized processes including training
• Drive and embed a preventive action culture via root cause investigation, using risk assessments in collaboration with Engineering and Operations
• Maintain compliant and state-of-the-art control processes, equipment and methods
• Participate in steering committees and project teams which originate from supplier, customer and manufacturing facilities
• Support and at times lead business initiates such as harmonization of control strategies, implementation of system enhancements, and execution of strategic initiatives like Annex 1
• Lead customer projects related to strategic initiatives like contamination reduction program /Annex 1
• Working with the QA Managers, develop a strategy within the advanced manufacturing sites to embrace trending and tracking rules against selected process parameters, quality attribute and variable data
• Enhance customer relationships by improving quality performance across key indicators
• Strengthen the Quality Culture of the advanced manufacturing sites by leading cross functional Quality Culture assessments at the sites and support site SLT by establishing appropriate action plans
• Provide guidance to the sites in case of major quality events including customer communication related to elastomers & metal products

Additional Responsibilities

• Identify best practices and ensure roll out to relevant sites
• Coach and direct teams to apply correct approach /DMAIC tools for improvement projects
• Train out when needed and lead by example as required

Education

• Bachelor's Degree Engineering or Applied Sciences or equivalent experience required
• Master's Degree preferred

Work Experience

• 10+ years of experience in leadership and management at a senior level in a relevant or associated business environment
• 10+ years of experience in quality project management / leadership position experience in a high volume Medical Device / Pharmaceutical environment

Preferred Knowledge, Skills and Abilities

• Lean Sigma trained with a proven track record of leading multiple value-add programs
• Excellent leadership and organizational skills
• Result driven with strong ability to influence key stakeholders
• Good presentation skills
• Must be able to organize and prioritize tasks, must be detail orientated and self-motivated.
• Must have excellent written and verbal communication skills. Must be able to work in a fast paced environment.
• Must have in-depth knowledge of West’s products, processes, systems, quality regulations and customer requirements

Additional Requirements

• Ability to multi-task, work under time constraints, problem solve and prioritize
• Must be able to maintain confidentiality and resolve conflicts
• Ability to enter cleanrooms in the required gowning/garments  #LI-JJ1

Travel Requirements

What We Offer