West Pharma Senior Manager Quality Integrated Systems 

Ireland, Dublin 

942057478

The Senior Manager, Quality Engineering position is a key strategic leader, overseeing execution of syringe system assembly, manufacturing, product testing, and life-cycle management goals and objectives for the West Integrated Systems Operating Unit under the direction of the Operating Unit Quality Leader. The role is responsible for developing and implementing compliant state-of-the-art QMS infrastructure to support manufacture and distribution of syringe systems and drug containment solutions.

This role will partner with R&D, Operations, Supply Chain, and Regulatory to ensure the successful execution of product manufacturing, while maintaining compliance, product integrity, and safety. The role will ensure solutions are implemented to support manufacturing high volume efficiencies and to ensure product platforms are compliant with regulatory and business requirements throughout the complete product lifecycle including commercialization, sustainment, and post market surveillance activities. This role is also responsible for Quality documentation to substantiate the product maintains compliance through manufacturing, distribution, post market surveillance. The role will also involve overseeing audit activities, investigating quality issues, and ensuring appropriate corrective and preventive actions (CAPAs) are implemented.

• Lead the development and implementation of a comprehensive product life-cycle manufacturing and distribution strategy for the I.S. OU that aligns with the company's and operating unit’s overall business objectives, ensuring sustainable and scalable solutions.
• Drive stabilization of the quality metrics and compliance profile of product manufacturing and post market surveillance activities for the operating unit.
• Develop and manage a high performing global team responsible for ensuring:
  • Execution of defined business goals & objectives
  • Products comply with product specifications and applicable global quality & regulatory requirements
  • Partner with internal (e.g., Global Quality, R&D, Supply Chain, Regulatory, etc.) and external stakeholders (e.g., suppliers, customers, etc.) to deploy strategic platform product manufacturing and post market surveillance strategies while ensuring compliance with FDA, ISO, Ministry of Health regulatory filing requirements, business needs, and contractual obligations.
• Oversee and provide direction to cross-functional teams on product development DHF/DMR documentation including but not limited to failure analyses, risk management activities, FMEAs (application, design and process), process flow analyses, design of experiments, process capability analyses, quality inspection procedures including sampling plans, and test method validation
• Oversee successful design transfer of new or updated products and manufacturing transfers from Product Development into Manufacturing, in collaboration with Operations and third party providers.
• Inspire and develop team members, providing access to training, coaching, and mentoring to foster growth and professional development. Collaborate with leadership to identify succession plans.
• Drive proactive, preventative behaviors and via a strong CAPA and to resolve product quality issues for commercialized products.
• 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 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
• Drive continuous quality improvement projects

• Bachelor's Degree in Science or an applicable engineering field or equivalent experiencein engineering
• Master's Degree

• Minimum 10 years of experience in regulated Quality industry
• Minimum 5 years of managing people / staff
• Extensive experience with medical device and/or combination device product life-cycle management including but not limited to: product development, design and manufacturing transfers, manufacturing, DHF & DMR documentation, risk management, and post-market surveillance activities.

• Experience with medical device and/or combination device product life-cycle management including but not limited to product development, design and manufacturing transfers, product manufacturing, Six Sigma & SPC tools and techniques, DHF & DMR documentation, risk management, and post-market surveillance activities
• Experience in overseeing the product life-cycle management of medical devices and/or combination devices in conformance with US & ROW regulations (ISO 13485, ISO 14971, 21 CFR 820, EU GMP, and EU MDR)
• Experience with customer interface and meeting customer expectations
• Proficient in statistical software, Windows OS, MasterControl, SAP, Share Point, Microsoft Office: Word, Excel, Power Point, and Teams
• Proficient in statistical software, Windows OS, MasterControl, SAP, Share Point, Microsoft Office: Word, Excel, Power Point, and Teams
• Be aware of all relevant SOPs as per Company policy as they relate to this role and able to comply with the company's safety and quality policies at all times
• Excellent project management, presentation, writing, verbal, computer, problem solving, interpersonal and communication skills, including the ability to tailor messaging to all levels of the organization.
• 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.

• ASQ or Industry Certification of Process Excellence/ Six Sigma Blackbelt preferred.
• Other ASQ certification of CQE, CQA or CQM preferred.

• Must possess knowledge of all relevant medical device and Combination device regulations, standards and guidance documents, such as: 21CFR Parts 4, 820, 806, 7, 803, 801, 11, ISO13485, ISO14971, EU MDD/MDR and EU GMP Annex 1: 2022.
• Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events
• Maintain the ability to work well with others in a variety of situations and maintain a high attention to detail, accuracy, and overall quality of work
• Must be able to multi-task, work under time constraints, problem solve, and prioritize
• Must be able to communicate effectively with written and oral skills, make independent and sound judgments decisions, interpret data, read & write, speak in front of groups, express & exchange ideas, understand direction and adhere to procedures
• Extensive experience in preparing for and managing regulatory inspections, including responses.
• Able to comply with the company’s safety and quality policies at all times.
• Ability to learn all relevant SOPs as per company policy as they are related to the position covered by this Job Description