Quality Project Manager

West Pharmaceutical Services•Exton, PA

42d•Hybrid

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 Summary In this role, the Quality Project Manager will support the standardization of QMS process and data management across the organization. This position will lead the development and deployment of quality maturity, QMS improvements and quality cost related measures, evaluations, performance, and initiatives. This position will coordinate activities associated with quality maturity including continuous improvement projects relating to sustaining engineering activities, development of new methods/processes for product evaluation and product development activities through a standardized approach. In addition, this position will deploy highly capable, predictive, effective, and efficient quality cost metrics for West Pharmaceuticals. This position will also be responsible for leading and executing cost improvement initiatives, follow up assessments and action oversight.

Requirements

Bachelor's Degree in Science, Engineering or related field
8+ years of relevant work experience required

Nice To Haves

5+ years' experience in pharmaceutical or medical device environment.
2+ years' experience in a Quality role.
ASQ CQE certification desirable.
Deep knowledge of quality processes such as CAPA, complaint management, risk management, root cause analysis, statistical sampling plans, FMEA/Fault Tree Analysis, Design Optimization using DOE, Hardware Reliability, Software Reliability, and Design Controls including Design Verification/Validation.
Knowledge of ISO 9001:2008, ISO 13485, 21 CFR 820, 21 CFR 210 & 211, cGMP, cGLP.
Ability to manage direct report(s), work independently and in a team environment.
Demonstrate innovativeness in tactical matters relating to proposing alternate solutions for process improvement.
Experience in FDA regulated environment, pertinent to ISO 13485 is preferred.
Experience with SAP is preferred.
Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
Able to comply with the company's safety policy at all times.
Able to comply with the company's quality policy at all times.

Responsibilities

Lead the initiative to standardize quality systems between multiple sites. Identify best practices and ensure roll out to relevant sites.
Organize and generate detailed quality information reports to show trends and the impact of process improvements.
Create repeatable methods to assess, measure and communicate the overall quality of a project and deliver key metrics to assess the overall improvement.
Establish and lead cross functional quality related meetings to review and discuss performance, status and prompting necessary actions as required.
Manage goals and metrics for Quality teams/initiatives to adequately monitor the overall effectiveness of the teams/initiatives.
Work with project managers, engineering team, and platform management to develop plans to implement improvement projects.
Ensures teams work closely with product development, supplier/contractors, design, quality, regulatory teams in order to establish standardized KPIs.
Work within Quality or across West Divisions to triage Customer Operational difficulties, define root cause(s), and coordinate the implementation of corrective and preventive actions to preclude recurrence related to quality improvements and quality maturity.
Manage or contribute to both corporate and facility driven initiatives intended to meet defined objectives.
Support front room and or backroom responsibilities during external audits. Including post audit activities, if required.
Responsible for assembling a project team, assigning individual responsibilities, identifying appropriate resources needed, and developing schedules to ensure timely completion of project.
Record detailed customer requirements, constraints, and assumptions with stakeholders in order to establish the project deliverables.
Responsible for project budget estimation, monitoring, and attainment throughout the project lifecycle.
Ensure a common understanding by setting expectations in accordance with the project plan in order to align the stakeholders and team members.
Lead the identification, assessment, monitoring, and closure of project risks throughout the project lifecycle.
Manage changes to the project scope, project schedule, and project costs using appropriate verification techniques in order to keep the project plan accurate, updated, and reflective of authorized changes to facilitate customer acceptance.
Responsible to improve team performance by building team cohesiveness, leading and motivating in order to facilitate cooperation, ensure project efficiency, and boost morale.
Measure project performance using appropriate tools and techniques in order to monitor the progress of the project, identify and quantify any variances, perform any required corrective actions, and communicate to all stakeholders.
May coordinate the activities of one or more exempt and/or non-exempt employees.
All other duties as required.