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Title:  Quality Systems and Compliance Manager

Requisition ID:  63892
Date:  Jul 10, 2024

Kinston, North Carolina, US

Department:  Quality


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:


Day to day planning and supervision of quality systems activities including quality systems availability, audit management, customer feedback and enterprise management system quality master data.

Ensure continuous improvement of processes to ensure quality product and customer service.

Representative for Global systems projects and systems upgrades


Essential Duties and Responsibilities:

  • Site QA Manager designee for QA Systems and customer engagement activities.
  • Host Customer and Regulatory audit
  • Prioritize & manage available QA systems resources to ensure on time scheduling and response timelines are achieved for customer audits, notifications responses, management reviews, and customer complaints
  • Ensure Kinston is represented in Global Quality System Project deployment to ensure compliance to standards and efficiency in doing business.
  • Prioritize & manage available QA systems resources to ensure schedule adherence for quality reporting.
  • Support validation of facilities and equipment.  Approve engineering studies and other protocols as required
  • Analyze data and provide reports and recommendations to management for continuous improvements
  • Monitoring of trends in association of quality systems use and effectivity (Deviation, CAPA, Change Control, Periodic Documentation Review etc.)
  • Ensure proper completion of Change Controls and monitor timely completion.  Approve Change Controls for QA.
  • Routinely evaluate employee performance and identify training needs. Provide guidance, leadership, and support to direct reports
  • Review and approve work time in the appropriate time keeping system.
  • Coach and counsel employees for performance, attendance and behavior. Participate in the resolution of employee relations issues.
  • Exhibits regular, reliable, punctual and predictable attendance.
  • Creates, prepares, implements and improves Quality Control KPIs metrics.
  • Determines/sets Goals & Objectives for the Quality control organization and training programs for team's development purposes.
  • Supports investigations related to Non conformances, Audit observations, CAPAs, or Issue Reviews as needed.
  • Ensures equipment is up to date on Preventive maintenance and calibration activities.
  • Other duties as assigned.


Basic Qualifications:

  • Bachelor's Degree in Technical or Engineering or equivalent experience required


Work Experience:

  • Minimum 8 years (Mgr) in quality control required
  • 3+ years of supervisory experience required


Preferred Knowledge, Skills, and Abilities:

  • Metrology Equipment experience
  • Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
  • Support and contribute in Lean Sigma programs and activities towards delivery of the set target
  • Able to comply with the company’s safety and quality policies at all times


Licenses and Certifications:

  • Certified Manager of Quality/Operational Excellence preferred


Travel Requirements:

  • Estimated Amount 5%: Up to 13 business days per year


Physical Requirements:

  • Medium, 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:

  • Must be able to work assigned shift(s) with overtime as required to complete assignments if necessary. Sitting and/or standing for extended periods may occur as well as getting to and from offices and building sites. If necessitated by customer requirements, must be able to see with or without corrective lenses and distinguish color differences for product and safety issues. Hearing ability should be sufficient to hear and react to audible alarms from distances up to 150 feet. The ability to be able to lift and carry various items up to 50 pounds for manufacturing positions or 30 pounds for administrative positions is required.
  • This job requires decision making based on data analysis
  • Must be able to generate, express, and exchange new ideas
  • Must be able to understand direction and adhere to established procedures 
  • Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read & write, speak in front of groups, express & exchange ideas, understand direction and adhere to procedures
  • Organizational skills will enable planning, prioritization & achievement of goals especially of importance for the successful execution of related activities
  • 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




West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening and/or drug screening.  

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