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Title:  Project Manager, Design Quality

Requisition ID:  35416
Date:  Oct 4, 2021

Scottsdale, Arizona, US

Department:  Quality



Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.


At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.


Job Summary:

In this role, the Design Quality Project Manager is responsible for leading  the project management process for multiple complex projects simultaneously within Design Quality to meet internal and external customer deliverables.  The incumbent will direct cross-functional team members to execute projects and tasks while actively ensuring products meet quality standards consistent with internal procedures, design controls, and other regulatory requirements.


The incumbent is a strong advocate for product, process, and system quality at all stages of product realization. Lead steering committees and project teams which originate from internal, supplier, customer and manufacturing facilities.  Develop systems or programs that support continual improvement of product, process or QMS.


The incumbent is responsible for driving projects to completion based on timelines, budget, and resources.  Collaborate with Design Quality, R&D, Operations Quality, Operations, Digital Quality, Supply Chain, and other team members to manage and prioritize activities based on risk impact to the project, ensure the project scope is maintained, ensure established processes are followed, and ensure goals are met.


Essential Duties and Responsibilities:


Project Responsibilities:

  • Lead and provide oversight to multiple product development projects throughout the organization, including involvement from multiple sites
  • Lead programs with high resource requirements, risk, and/or complexity
  • Ensure the West project management process and methodology is implemented on all applicable projects
  • Identify scope, requirements and deliverables for internal and external projects
  • Ensure that detailed project plans and schedules are developed and maintained
  • Utilize a risk management approach to minimize, monitor, and control the probability and/or impact of unfavorable events
  • Hold team members accountable for their individual deliverables
  • Support implementation of and improvements to a harmonized QMS
  • Conduct project reviews with Project Teams and escalate to Management as necessary
  • Review customer quality agreements for accuracy and completeness
  • Work cross-functionally with individuals and project or extended teams to ensure success of projects
  • Collaborate with internal and external customers to identify project tasks, milestones, and objectives
  • Responsible for coordinating project tasks and identification of project risks
  • Document project team and customer meetings and follow up on open action items
  • Create and maintain project documentation to communicate status and progress
  • Initiate project change alerts in the case of delays, changes in scope, or deliverables
  • Monitor resource needs and issues, work closely with resource managers to develop action plans to ensure program commitments remain on track.
  • Identify and manage cross-project dependencies, critical items, risks, and issues
  • Facilitate after action reviews as appropriate to identify successful and unsuccessful project elements
  • Provide internal and external technical presentations as necessary
  • Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations and standards.
  • Facilitate and lead company and customer meetings and drive resolution of project issues

General Responsibilities:

  • Exhibit a strong “quality first” mentality and ensure that product and process quality are held to the highest standard
  • Communicate complex concepts; anticipate potential objections and influence others
  • Drive transparency of program workloads, financial, commitments, and expectations
  • Communicate with cross-functional stakeholders including senior management on complex projects involving multiple departments
  • Meet company and departmental goals in the continuous improvement of all products, services and processes, including the West QMS
  • Build and maintain strong relationships with customers, business partners, resource managers, and other senior level executives
  • Adhere to all company policies
  • Follow all safety rules and safety procedures
  • Must observe all good housekeeping practices
  • Other duties as assigned

Basic Qualifications: 

  • Minimum 5-8 years of experience leading project management initiatives within regulated industries
  • Bachelor's in relevant and/or applicable industry
  • Relevant work history and/or experience may be considered in lieu of degree
  • Track record of successfully managing global large-scale, high-risk programs
  • Excellent written and oral communication skills
  • Excellent critical reading and writing skills
  • Must have effective problem solving and interpersonal skills
  • Ability to work independently, multi-task and thrive in fast-paced environment
  • Problem solving including root cause failure analysis methods
  • Excellent planning/organizational skills
  • Proficient in Windows OS, Microsoft Office Suite including Word, Excel, Project, and Power Point
  • 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 comply with the company’s safety policy at all times


Preferred Knowledge, Skills and Abilities:

  • PMP certification
  • Experience with medical device regulations (ISO 13485 and 21 CFR 820)
  • Graduate degree


Travel Requirements:

  • Must be able to travel up to 20% of the time


Physical & Mental Requirements:

  • Adaptable to changes in the work environment, 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
  • Must be able to multi-task, work under time constraints, problem solve, and prioritize
  • Maintain high attention to detail, accuracy, and overall quality of work
  • Effectively communicate and interface with various levels internally and with customers
  • Work under deadlines with constant interruptions







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 kimberley.eby@westpharma.com.  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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