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Director of Customer Facing Quality

Requisition ID:  35650
Date:  Jul 8, 2021
Location: 

Dublin, Leinster, IE

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 Director/Senior Director of Customer Facing Quality, will lead and build a dynamic CM/Medical Device wide team focused on standardizing and deploying best in class Customer Facing quality processes and communications. This person will lead the engagement and interaction with key customers driving alignment on quality related targets and goals. As a result, this person will deploy standardized customer facing quality data management and reporting across all CM/Medical Device sites. This will require the use of highly capable, predictive, effective and efficient quality related KPIs and metrics.  

 

Essential Duties and Responsibilities:

  • Lead a global team of Quality personnel from across multiple sites within the CM/Medical Device network.
  • Develop and deploy a Customer Facing Quality strategy supporting the overall strategic vision and goals of the CM/Medical Device Quality, Commercial and Operational strategies.
  • Liaise and support other customer facing leaders from across the West functions.
  • Develop and deploy standardized communication methods, tools and process for quality engagement with customers.
  • Engage and communicate directly with customers on quality related matters driving a consistent and meaningful West Quality message.
  • Leverage talent and experience across West to identify and deploy standardized best in class customer facing quality processes across CM/Medical Device sites.
  • Develop tactics to drive rapid response to Customer issues.
  • Organize and generate detailed quality information reports to show credible and predictive trends driving identification and achievement of customer related quality targets and goals.
  • Develop and deploy in house predictive and effective measures of customer quality allowing early identification and mitigation of issues.
  • Create repeatable methods to assess, measure and communicate the overall effectiveness of the customer complaint handling process.
  • Work with project managers, engineering team, and platform management to develop plans to implement Quality Improvement Program (QIP) workstream activities.
  • 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.
  • Manage or contribute to both corporate and facility driven initiatives intended to meet defined objectives.
  • Communicate to global Quality leadership issues that impact product quality, safety or efficacy, compliance or business continuity which have arisen via local customer complaints.
  • Introduce and implement strategic business initiatives with supporting functions that will help to ensure the external supply chain is capable of meeting expectations from a quality, delivery and cost perspective.
  • All other duties as required.

 

Basic Qualifications: 

  • Bachelor’s degree in Science, Engineering, or related field
  • Experience: 12-15 years

 

Preferred Knowledge, Skills and Abilities:

  • Minimum of 15 years’ experience in pharmaceutical or medical device environment; minimum 8 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: 2016, 21 CFR 820, 21 CFR 210 & 211, cGMP, cGLP
  • Demonstrates the ability to lead and navigate in a global organization with a broad scope and high level of complexity.
  • Leadership ability to develop and implement organizational and functional strategy. Initiates, sponsors and implements change and a demonstrated track record in QA involvement.
  • Demonstrate innovativeness in tactical matters relating to proposing alternate solutions for process improvement.
  • Works effectively with cross functional teams to produce innovative solutions. Demonstrates Initiative, ability to efficiently prioritize and manage multiple projects.
  • Experience in FDA regulated environment, pertinent to ISO 13485 is preferred
  • Experience with SAP is preferred
  • Experience with Lean Sigma programs and activities

 

Travel Requirements:

  • 25% travel may be required, including internationally

 

Physical & Mental Requirements:

  • Work in a manufacturing environment, subject to heat and cold as well as loud noise
  • Work in an office environment. At times must sit for extended periods of time
  • Ability to effectively communicate and comprehend complex ideas and concepts
  • Use written and oral communication skills
  • 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
  • Observe and interpret situations, analyze and solve problems
  • Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events.
  • Maintain high attention to detail, accuracy, and overall quality of work.
  • Effectively communicate and interface with various levels internally and with customers.
  • 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
  • Able to comply with the company’s quality policy at all times

 

 

 

 

 

 

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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