Supervisor, Quality Customer Compliance

 

This is an onsite position requiring the team member to be onsite 5 days a week 

 

Who We Are:

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, you will manage, coordinate and administer the site customer compliance program: customer audits, complaints, projects and initiatives for continuous improvements and customer specifications.  
• Manage and support internal projects and ensure compliance with cGMP, applicable ISO requirements and company policies and procedures. 

Essential Duties and Responsibilities

• Manage and support internal and external customer audits
• Manage the customer complaint process, review/approve (where required) complaint reports to ensure investigations are complete and thorough and customer response letters are adequate
• Analyze data and provide reports and recommendations to management for continuous improvements
• Oversee Supplier Relationship Management (SRM) meetings with customers
• Manage and oversee internal and external customer projects/initiatives
• Review/approve customer specifications
• Manages cross functional team to that interfaces with internal and external customers .
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Exhibits regular, reliable, punctual and predictable attendance
• Prepare weekly, monthly, and quarterly reports to trend quality performance
• Other duties as assigned based on business needs
• Ensure adherence to corporate Quality System requirements

Education

• Bachelor’s degree in science, engineering  or related field or associate’s degree with relative experience preferred or equivalent work experience

Work Experience

• Minimum 3 years of progressive experience in Quality Assurance, Quality Control, or cGMP environment 

• At least 1 year experience in managing others preferred 

• At least 1 year experience in a customer-facing role preferred 

Preferred Knowledge, Skills and Abilities

• Previous employment within the pharmaceutical, Health Care or Food/Beverage manufacturing industry preferred 

• Understanding of working Quality Management System (QMS) preferred but not required.  

• Experience with customer interface and meeting customer expectations 

• Experience with ISO 9001, 15378, cGMPs requirements  

• Working familiarity with Project Management tools and Quality Risk Management 

• 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 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.