Quality Assurance Manager

West Pharmaceutical Services • Cidra, PR

1d • Onsite

About The Position

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 SummaryIn this fully onsite position, the employee is responsible for providing expertise in Quality Assurance processes related to the manufacture of West products. Ensure compliance to regulatory requirements and West procedures. Proactively develop, lead, and drive the execution of the Quality Assurance strategy. Develop and implement quality assurance plans ensuring compliance with regulations, oversee interactions with regulatory agencies and build strong relationships with internal and external stakeholders. Champion advocacy for product, process, and system quality, and drive continuous improvement within the Quality Management System.Essential Duties and Responsibilities Maintain a positive working relationship with internal and external stakeholders by supporting validation in design and development, specification development, and execution of manufacturing programs in line with agreed standards. All the while ensuring that West’s product quality and reliability meets or exceeds customers’ expectations. Responsible for the development of the quality assurance plans and systems to ensure commercial manufacturing, development programs and NPI programs remain compliant with all applicable regulations and guidelines. Support regulatory agency interaction related to compliance to local and regional guidelines/ regulations. Champion a quality/ patient first organizational culture that promotes behaviors that lead to superior quality and business performance and enterprise excellence. Support programs and flawless transition into Operations. Work cross-functionally with project teams to provide direction and support for technical / design review activities. Partner with Research and Development and Operations engineering teams to identify and implement solutions for defects or problems. Partner with West stakeholders during design transfer to ensure supplier validations are complete and effective. 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. Support QMS activities including CAPA, Failure Investigation, Non-Conformance assessment, and audit findings. May have people management responsibilities.

Requirements

• Bachelor's Degree Engineering or related technical discipline required
• Minimum 8 years Related experience required
• Expertise in quality management tools and supply chain methodologies – APQP, PPAP, MSA, SPC.
• Strong working knowledge of quality systems such as ISO 13485, ISO 9001, ISO 15378, 21 CFR 820, ISO 14971
• Working knowledge of supplier quality management from product development to high volume production
• Strong project management skills, communication skills, problem solving, and interpersonal skills.
• Able to exhibit a strong “quality first” mindset and ensure that product and process quality are held to the highest standard.
• Ability to work independently, multi-task and thrive in fast-paced environment.
• Strong problem-solving skills including root cause failure analysis methods.
• Proficient in statistical software, Windows OS, Microsoft Office: Word, Excel, Power Point, and Teams
• Be aware of all relevant SOPs as per Company policy as they relate to this role.
• Able to comply with the company’s safety policy at all times.
• Strong project management skills
• Adaptable to changes in the work environment, able to manage competing demands and deal with frequent change, delays, or unexpected events.
• Must maintain the ability to work well with others in a variety of situations.
• Maintain high attention to detail, accuracy, and overall quality of work.
• Must be able to understand and adhere to established procedures, multi-task, work under time constraints, problem solve, and prioritize.
• Effectively communicate and interface with various levels internally and with suppliers.

Nice To Haves

• Master's Degree
• Engineering - Development\Certified Software Quality Engineer (ASQ CSQE) preferred
• Manufacturing\Six Sigma Green Belt Certification
• Previous experience with MasterControl, SAP, SharePoint, Teamcenter

Responsibilities

• Maintain a positive working relationship with internal and external stakeholders by supporting validation in design and development, specification development, and execution of manufacturing programs in line with agreed standards. All the while ensuring that West’s product quality and reliability meets or exceeds customers’ expectations.
• Responsible for the development of the quality assurance plans and systems to ensure commercial manufacturing, development programs and NPI programs remain compliant with all applicable regulations and guidelines.
• Support regulatory agency interaction related to compliance to local and regional guidelines/ regulations.
• Champion a quality/ patient first organizational culture that promotes behaviors that lead to superior quality and business performance and enterprise excellence.
• Support programs and flawless transition into Operations.
• Work cross-functionally with project teams to provide direction and support for technical / design review activities. Partner with Research and Development and Operations engineering teams to identify and implement solutions for defects or problems.
• Partner with West stakeholders during design transfer to ensure supplier validations are complete and effective.
• 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. Support QMS activities including CAPA, Failure Investigation, Non-Conformance assessment, and audit findings.
• May have people management responsibilities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees