Manager Quality Assurance, Integrated Systems

West Pharmaceutical Services View all jobs

Waterford
Permanent
Full-time

1 month ago

This is a hybrid position requiring the team member to be onsite a minimum of 3 days per weekNo relocation is provided for this opportunityWho 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.What We OfferGenerous Paid Time Off (PTO): Flexible vacation, personal, and holiday leave ensures employees can maintain a healthy work-life balance and recharge effectively.Inclusive & Collaborative Culture: A global workforce that values diversity, equity, and inclusion-where all voices are heard and respected in a supportive environment.Recognition & Rewards: Performance-based bonuses, service recognition, and employee appreciation initiatives celebrate dedication and impact.Job SummaryThe primary responsibilities of the Customer Quality Manager, Integrated Systems, involve over-sight of the Quality Management System (QMS), Customer Quality issues, questions / concerns, Customer facing related items and audits as well as overseeing supplier performance metrics and support / drive supplier audits, out of specification (OOS) investigations. Lead and drive internal teams to resolve Out of Spec (OOS) quality issues and be the main point of contact for customers on these issues. Partners closely with internal stakeholders i.e Operations, Technical Customer Support, Sales, Labs, R&D, and Product Management to ensure that customer quality issues are resolved in a timely manner and the needs of the customer are being met. Maintaining and reporting metrics and trends to Senior Management and Extended Leadership Team (ELT) and implementing improvements on a continuous and pro-active basis. Generate, manage and oversee customer and supplier quality agreements Ensuring compliance to corporate, regulatory and customer quality standards will be at the forefront of the responsibilities. Reports directly to the Snr Quality Engineering Manager.Essential Duties and Responsibilities

System Owner of the Integrated Systems (IS) Quality Management System (QMS)
Hosting of third-party audits, control room set-up and management of general audit readiness throughout the business.
Post Audit follow-up and reporting both internally & externally on action completion and verification of effectiveness to ensure audit findings are closed out satisfactorily.
Coordinate the monthly Quality Systems KPI reporting activity both internally and to corporate level.Support customer regulatory submissions as required.Interface with other departments on a regular basis to ensure adherence to IS QMS, drive quality improvements and compile/relay trends and occurrences throughout the year.
To coordinate and support complaint handling of product complaints received by customer
Interface on an ongoing basis with customers to ensure requirements / concerns / complaints are communicated and corrective and preventive actions are closed in a timely and effective manner.
To open, track and maintain records for complaints received by customers.
Lead investigations into customer / material / product issues to ensure a thorough root cause, containment / corrective and preventive action is implemented.
Generate and maintain quality metrics for reporting to ELT
Support risk management, risk analysis and health hazard analysis associated with complaint/post-market information.
Develop technical product expertise to assess adequacy of complaint information from the field and review of complaint investigations.
Participate in or lead customer review meetings
Create and maintain customer quality dashboard
Perform trending of customer quality dashboard based on customer data

Main point of contact for customer regarding complaints, queries, change notifications, minor, major and critical change notification analysis and audits * Co-ordinate internal resources, timelines and activities to drive resolution of customer OOS and non OOS quality issues

Co-ordinate internal and external communications related to customer issues (OOS and Non OOS)
Work with customer and internal stakeholders to create customer quality plans where applicable
Generate, manage and oversee customer and supplier quality agreements
Keep current with the industry standard practices and relevant regulatory requirements
Perform additional duties at the request of the direct supervisor.

Basic Qualifications

BA/BSE in a technical or related field plus 5 years of demonstrated experience in the administration of Quality Systems, or a combination of education and experience.
Must have 5+ years' work experience in Medical Device or Pharmaceutical Manufacturing Environment.
A thorough working knowledge of quality systems such as ISO 15378 /ISO 13485 / 21 CFR Part 820 / EU GMP is essential.
Accredited lead auditor against recognized quality standards in support of audits
Have experience in the facilitation of quality risk management coupled with a good working knowledge of ISO14971.
Experience of hosting regulatory audits from either the European or US authorities
Must have excellent communication and written skills
Must be able to work in a fast paced environment.
Must be able to travel as required by the position.
Must be able to organize and prioritize tasks, problem solve, must be detail orientated and self-motivated.
Must be able to work independently on own projects while working concurrently with all departments

Preferred Knowledge, Skills and Abilities

Knowledge of and experience in setting up and maintaining an effective QMS.
An ability to collaborate across functional roles and work effectively in a team environment
Knowledge of GMP requirements
Customer facing experience
Project management experience
Strong project management skills
Previous experience with MasterControl, SAP, SharePoint, Teamcenter #LI-NJ1 #LI-Hybrid

License and Certifications

Engineering - Development\Certified Software Quality Engineer (ASQ CSQE) preferred
Manufacturing\Six Sigma Green Belt Certification

Travel Requirements10%: Up to 26 business days per yearPhysical 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 Requirements

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.

West 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.

West Pharmaceutical Services

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