West Pharmaceutical Services

Quality Assurance Manager

West Pharmaceutical Services

full-time

Posted on:

Location Type: Office

Location: Cidra • 🇺🇸 United States

Visit company website
✨ AI Apply
Apply

Job Level

SeniorLead

About the role

  • Provide expertise in Quality Assurance processes related to manufacture of West products
  • Ensure compliance to regulatory requirements and West procedures
  • Develop, lead, and drive execution of the Quality Assurance strategy
  • Develop and implement quality assurance plans ensuring compliance with regulations
  • Oversee interactions with regulatory agencies
  • Build strong relationships with internal and external stakeholders
  • Champion advocacy for product, process, and system quality
  • Drive continuous improvement within the Quality Management System
  • Support regulatory agency interaction related to compliance to local and regional guidelines/regulations
  • Support programs and flawless transition into Operations
  • Work cross-functionally with project teams to provide direction and support for technical/design review activities
  • Partner with Research and Development and Operations engineering teams to implement solutions for defects/problems

Requirements

  • Bachelor's Degree in Engineering or related technical discipline
  • Minimum 8 years of related experience
  • Expertise in quality management tools and supply chain methodologies – APQP, PPAP, MSA, SPC
  • Strong working knowledge of quality systems such as ISO 13485, ISO 9001, ISO 15378, 21 CFR 820, ISO 14971
  • Working knowledge of supplier quality management from product development to high volume production
  • Strong project management skills
  • Proficient in statistical software, Windows OS, Microsoft Office: Word, Excel, Power Point, and Teams
  • Engineering - Development Certified Software Quality Engineer (ASQ CSQE) preferred
  • Manufacturing Six Sigma Green Belt Certification
Benefits
  • benefit programs for physical, mental, emotional, and financial health
  • support for lifelong learning, growth, and development
  • giving back to help communities
  • sustainability efforts

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
quality assurancequality management toolsAPQPPPAPMSASPCISO 13485ISO 9001ISO 1537821 CFR 820
Soft skills
relationship buildingadvocacycontinuous improvementcross-functional collaborationproject management
Certifications
Bachelor's Degree in EngineeringCertified Software Quality Engineer (ASQ CSQE)Six Sigma Green Belt Certification