West Pharmaceutical Services · 19 hours ago
Senior Quality Manager
Williamsport, PA
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expWest Pharmaceutical Services is a company dedicated to improving patient lives through innovative healthcare solutions. The Senior Quality Manager will be responsible for overseeing Quality Assurance processes, ensuring compliance with regulatory requirements, and driving the execution of quality strategies while collaborating with internal and external stakeholders.
BiotechnologyHealth CareIndustrialManufacturingPackaging ServicesPharmaceutical
Responsibilities
Reporting to the Sr. Director, Quality Assurance, the role will play a critical part in the company’s business planning / strategy development
As a member of the Site Leadership Team, deeply engages and effectively contributes to the achievement of site objectives by playing an active role in the strategic planning processes
The role will also have a dotted line reporting relationship to the Director, Operations, Williamsport to ensure development and alignment of the site business plan including support to the other senior managers in the execution of same
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
Directs and manages quality control, quality assurance, quality systems, metrology and/or regulatory affairs, personnel, department resources, and continuous improvement efforts to achieve the most efficient quality output possible
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
Perform the necessary functions in support of the Williamsport Quality System
Designated ISO 13485 Management Representative
Designated back-up to QA Supervisor for HACCP Manager and SQF Practitioner
In accordance with US and other regional/ country legislation, act as Head of Quality Control/ Head of Quality/ Official Correspondent on all government agency issued authorizations, communications and registrations
Cultivate a positive working relationship with the West Customer base via supporting validation in design and development, agreeing specification, execution of manufacturing and programs in line with agreed standards. All the while ensuring that the West’s product quality and reliability meets or exceeds customers’ expectations
QA representative participating in customer face to face steering committees and business review which originate from site customer base. Chairing customer meetings with respect to Quality standards and expectations
Champion a quality/ patient first organizational culture that promotes behaviors that lead to superior quality and business performance and enterprise excellence
Participate in customer, regulatory, and internal audits of the plant; participate in supplier audits and participate as part of the Corporate Cross Site Audit Team
Review and assist on the updating of customer specifications. Respond to customer/sales regarding the approval or recommended changes to these specifications and maintain a file of the responses and the specifications
Oversees complaint handling, non-conformance management, internal and external audits, and CAPA system to ensure timely and compliant systems. Evaluates and provides for audits of external and internal quality systems and their functions, insuring follow through and corrective actions
Establish, monitors, and provides weekly / monthly progress of the Quality KPIs and communicate it to the organization and senior management
Responsible and accountable for quality departmental budget
Other duties as assigned
Qualification
Required
Bachelor's Degree in engineering, mechanical engineering, chemical engineering, manufacturing engineering, industrial engineering or equivalent experience required
10+ Years of job-related experience required in the Medical Device or Pharmaceutical Industry
8+ Years of supervisory experience required
5+ Years of experience in an FDA or ISO regulated industry required, preferably in medical device manufacturing
Excellent communication and interpersonal skills must be coupled with public speaking, quick decision making
Excellent written and oral communication skills
Medical component and device manufacturing require strict adherence to standards
Strong communication and technical writing skills, interpretation of data, interpersonal skills, ability to work on and lead teams
Read and interpret data, information, and documents
Must maintain the ability to work well with others in a variety of situations
Must be able to multi-task, work under time constraints, problem solve, and prioritize
Ability to make independent and sound judgments
Demonstrates enthusiasm, takes accountability, and drives for results
Superior organizational and leadership skills with ability to help team grow and thrive
Able to lead and front multiple third party Medical Device / Pharmaceutical audits
Able to interact with global Medical Device / Pharmaceutical agencies in support of queries / product launches
Have in-depth / working knowledge of: ISO 13485, US FDA 21 CFR Part 820, ISO14971
Have strong self-motivation, the ability to work independently, and within a team environment with strong follow up, organization and prioritization skills and excellent attention. Must have a proven track record of developing and maintaining positive customer relationships
Able to lead and manage the performance of a multi-functional team
Able to organize and prioritise tasks, must be detail orientated and self-motivated
Have excellent written and verbal communication skills. Must be able to work in a fast paced environment
Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
Able to always comply with the company's safety and quality policy
Preferred
Master's degree preferred
5+ Years of experience working with injection molding processes preferred
Project Management experience preferred
Benefits
Relocation assistance
Company
West Pharmaceutical Services
West Pharmaceutical Services is a manufacturer of technologically advanced containment and delivery systems for injectable medicines.
5001-10000 employees
H1B Sponsorship
West Pharmaceutical Services has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (14)
2024 (24)
2023 (18)
2022 (26)
2021 (17)
2020 (15)
Funding
Current Stage
Public CompanyTotal Funding
unknown1978-01-13IPO
Leadership Team
Eric Green
Chairman, President, and CEO
Atul Patel
Vice President, Devices & Delivery Systems
Recent News
2025-12-06
Company data provided by crunchbase