Title:  Sr. Director, QA Design Quality & Risk Management

Job Summary

The Sr. Director of Design Quality and Risk Management serves as a key strategic partner to successfully drive harmonized, compliant, and effective product development processes across the enterprise.  The role is responsible for maintaining compliant and state-of-the-art design control and risk management processes across the enterprise as well as overseeing the QMS’s integrity and effectiveness for West Pharmaceutical Services.  They will lead a team who provide quality compliance oversight to the network of Design Centers at the corporate level and support for the Operational Units’ level Design Center QMS which supports multiple concurrent development programs including medical devices, pharmaceutical combination products, and Containment.  

This global role will partner with global sites and global cross functional teams including R&D, Regulatory, Operations, and Operations Quality to ensure a robust QMS infrastructure is in place which facilitates the development of safe, effective, and compliant products.  This role also oversees a design responsible QMS and continually monitors its effectiveness to ensure regulatory compliance while being adept to support and scale with business needs.

The incumbent will be a strong advocate for product, process, and system quality at all stages of product realization. Participate in steering committees and project teams which originate from supplier, customer and manufacturing facilities.  In partnership with other Global Design Quality leaders and Global R&D leaders, this role will drive global harmonization of the overall enterprise QMS.  #LI-CT1

Essential Duties and Responsibilities

• Develop and manage a high-performing West Design Quality global team responsible for ensuring: 
  • Execution of defined business goals & objectives 
  • QMS processes which facilitate development of product which comply to applicable international quality and regulatory requirements 
• Partner with other Global Design Quality and Global R&D leaders to deploy strategic platform product development approaches to product development.   
• Partner with other Global Design Quality and Global leaders to deploy harmonized, compliant, and scalable QMS solutions across the enterprise. 
• Oversee and provide direction to cross-functional teams on design control and QMS elements including but not limited to change control, training, CAPAs, issue reviews, audit findings, investigations, risk management activities, document control, configuration control, and quality agreements. 
• Establish, trend, and review KPIs and metrics with cross-functional leaders to drive improvements to the applicable elements of the QMS. 
• Provide support in the creation of, resourcing for, and enforcement of development agreements for West proprietary products in collaboration with commercial, product management, R&D, regulatory, and operations. 
• Understands customers’ requirements and needs during the development agreement stages to define a standard method for establishing, implementing, and enforcing customer agreements. 
• Work closely with Global and site level Operations and Operations Quality regarding the interpretation and implementation of Design Controls and Risk Management to ensure smooth technical transfers into Operations. 
• Ensure cross-functional teams collaborate across the enterprise.  Communicate key messages, goals, and objectives to team members to drive alignment and a high-performance culture. 
• Partner with other Design Quality leaders and Global Quality Systems leadership in developing and implementing lean QMS processes at the enterprise level.  Lead and drive compliance to global harmonization initiatives and objectives. 
• Direct a harmonized design control and risk management program globally within the enterprise with the support of Design Quality leadership.  Proactively identify potential gaps and direct teams to resolve them. Lead continuous improvement initiatives to ‘challenge’ quality systems processes with respect to compliance / value add.  
• Identify, develop, mentor, and lead Design QA talent to ensure the highest standard of Quality support is provided to R&D design, development teams, and SDC. Collaborate with leadership to identify succession plans. 
• Forecast and ensure the appropriate level of Design QA staffing is maintained.   
• Partner with organizational leaders and drive quality initiatives, systems, and methods to meet quality objectives.  Meet company and departmental goals in the continuous improvement of all products, services and processes, including the West QMS.  
• Oversee QMS activities including CAPA, Failure Investigation, Non-Conformance assessment, audit findings, issue reviews, etc.  Provide leadership and direct input on any nonconformance, deviation, or excursion that may occur and drive to closure. 
• Remain aware of developments in the quality field by reading current technical literature and attending technical meetings and/or industry conferences.  
• Fill in for the Vice President of Corporate Quality as requested or required 
• Drive continuous quality improvement projects 
• Other duties as assigned 

Education

• Bachelor's Degree Bachelor of Science in Engineering or Management/ Leadership required
• Master's Degree Engineering or Business preferred

Work Experience

•    Minimum 12 years of experience in regulated Medical Device and Pharmaceutical industry.  Previous experience with Pharma containment and Drug delivery devices is a plus. 
•    Have previously led and managed the performance of multi-functional team(s) in Quality 
•    Experience with Medical Device Design & Development, Verification / Validation Activities, Risk Management, Product Transfer, DHF Activities
•    Have experience in overseeing the design and development of medical devices in conformance with US FDA, CE Marking requirements, and/or similar regulatory approval routes
•    Experience with customer interface and meeting customer expectations
•    Experience using Six Sigma & SPC tools and techniques
•    Experience with medical device regulations (ISO 13485, ISO 14971, 21 CFR 820, EU GMP, and EU MDR)
•    Experience with Pharma Standards / regulations (FDA 21 CFR 210 & 211, ISO 15378, the EU GMP Annex 1)

Preferred Knowledge, Skills and Abilities

• Understanding of requirements for initiating and managing Medical Device/Combination Device recalls, withdrawals, or other field actions with FDA, EU competent authorities and other Ministries of Health.
• Robust understanding, experience and execution of Root Cause Analyses, Investigations, CAPA, and Post-Market Surveillance (including reportability) in the Medical Device and/or combination device industry.
• Understanding of Computer System validation requirements for systems /platforms and for product firmware/software, as well electronic signature (21CFR part 11) requirements.
• Demonstrated leadership skills, including team building, employee development, and performance management and strong ability to develop rapport and partnership with customers and understand their product requirements.
• Excellent presentation, writing, verbal, computer, interpersonal and communication skills, including the ability to tailor messaging to all levels of the organization from the c-suite to manufacturing operators/QC inspectors.
• Ability to adapt to frequent changes, unexpected events and still yield an effective outcome, as well as manage competing demands, make timely and sound decisions, even under conditions of risk.
• Strong project management skills  
• Green or Black Belt certification  
• Previous experience with MasterControl, Veeva, SAP, Share Point, Teamcenter 
• Experience with ISO 60601, ISO 62366, ISO 11607 a plus 

License and Certifications

• Process Analysis /Certified Quality Process Analyst - ASQ ASQ or Industry Certification of Process Excellence
• Other ASQ certification of CQE, CQA or CQM preferred

Travel Requirements

Physical Requirements

What We Offer