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Title:  Sr. Specialist, Quality Audit Program

Requisition ID:  56252
Date:  Nov 14, 2022
Location: 

Exton, Pennsylvania, US

Department:  Quality
Description: 

 

 

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:

This role will lead and oversee activities to support the West’s Global Audit Program within Quality System.  The role will work closely with West’s Supplier Management Program to perform supplier audits, as well as direct involvement in Corporate Facility Audits and third-party certification body audits.

 

Essential Duties and Responsibilities:

  • Lead continual engagement with Supplier Quality Management and Procurement to ensure alignment with supplier risk mitigation strategy and communicate on audit program priorities.
  • Independently performs supplier audits and corporate facility audits.
  • Develop process to evaluate audits and to define current quality trends which are then identified as a point of focus for internal and external audits evaluate impact on global quality systems to mitigate systemic risk.
  • Lead in the development, implementation, execution, and continual improvement of Audit Management Program.
  • Lead the development and exeuction global auditor training materials for greater increase of global auditor communication.
  • Maintain corporate quality audit schedule and all applicable audit documentation within the defined system.
  • Serve as corporate point of contact for global third-party certification body audits and related outputs.
  • Develop processes for utilization of SAP Audit Module to schedule, track and maintain all corporate facility, supplier and third-party certification body audits.
  • Evaluate outputs, from Global Audit Program activities for organizational communication and input into management review.
  • Establishes monthly KPI’s and metrics to Sr. Quality Leadership.
  • Participate in technical discussions to assess and determine internal operations and supplier capabilities.
  • Review, revise and create operating procedures to ensure compliance with all related external requirements, internal procedures or instructions, and the West Quality Manual.
  • Drive continuous quality improvement projects across the enterprise for increased compliance and to create efficient use of company resources.

 

Basic Qualifications: 

  • Bachelor’s Degree in Science or related field
  • Experience: Minimum of (5) years in Quality Assurance.
  • Understands and interpretation and application of quality standards in a regulated environment such as 21CFR 210 211, ISO 9001, ISO 13485 and ISO 15378

 

Preferred Knowledge, Skills and Abilities:

  • Certified Quality Auditor
  • Experience with Supplier Quality Management
  • Customer / Supplier interface and meeting expectations.
  • Working knowledge of Pharmaceutical Industry requirements for elastomeric closures and medical devices.
  • Able to comply with the company’s safety policy at all times
  • Able to comply with the company’s quality policy at all times.

 

Travel Requirements:

  • Approximately 20-30% travel, domestic and international

 

Physical & Mental Requirements:

  • Work in an office environment. At times must sit for extended periods of time.
  • Strong communication and technical writing skills, interpretation of data, interpersonal skills, ability to work on and lead teams.
  • 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.

 

 

 

 

 

 

 

 

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 Apply.Accommodation@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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