Senior Manager, Quality, Integrated Systems

This is an office based role at the Dublin Ireland location.

 

Who we are:

 

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?  

 

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.  

 

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.  

Job Summary

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 manage all team members in Ireland, oversee product release including management of all third-party subcontractors and their operations, will be responsible for post-market surveillance, complaint handling, and will ensure product quality is maintained.  The Senior Manager will work cross-functionally with global leaders to ensure harmonization, alignment, and best practices across the QMS and product platforms. The Senior Manager will also build and maintain a high-performing team, ensuring talent development and succession planning within the OU for Quality.

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.

Essential Duties and Responsibilities

• 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:
  • o Execution of defined business goals & objectives
  • o 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