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Title: Senior Manager, Quality, Integrated SystemsRequisition ID: 68624
Date: Apr 8, 2025
Location:
Dublin, Leinster, IE
Department: Quality
Description:
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 SummaryThe 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 ResponsibilitiesLead 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 & objectiveso Products comply with product specifications and applicable global quality & regulatory requirementsPartner 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 validationOversee 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 culturePartner 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 QMSOversee 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 closureRemain aware of developments in the quality field by reading current technical literature and attending technical meetings and/or industry conferencesFill in for the OU Quality Leader as requested or requiredDrive continuous quality improvement projectsOther duties as assigned
EducationBachelor's Degree in Science or an applicable engineering field or equivalent experience in engineeringMaster's Degree Engineering or BusinessWork ExperienceMinimum 10 years of experience in regulated Quality industryMinimum 5 years of managing people / staffExtensive 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.Preferred Knowledge, Skills and AbilitiesExperience 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 activitiesExperience 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 expectationsProficient in statistical software, Windows OS, MasterControl, SAP, Share Point, Microsoft Office: Word, Excel, Power Point, and TeamsExcellent 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.License and CertificationsASQ or Industry Certification of Process Excellence/ Six Sigma Blackbelt preferred.Other ASQ certification of CQE, CQA or CQM preferred.Travel Requirements20%: Up to 52 business days per year
Physical RequirementsMedium-Exerting up to 50lb/22kg of force occasionally and/or up to 20lbs/9kg of force frequently, and/or up to 10lbs/4kgs of force constantly to move objects.
Additional RequirementsMust 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 eventsMaintain the ability to work well with others in a variety of situations and maintain a high attention to detail, accuracy, and overall quality of workMust be able to multi-task, work under time constraints, problem solve, and prioritizeMust 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 proceduresExtensive 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 DescriptionWest is an equal opportunity employer and we value diversity at our company.
We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.
If you have a special need that requires accommodation in order to apply to West, please send an email to ****** .
Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.
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