Senior Specialist, Supplier Quality

Job Summary

In this role you will be responsible for performing Supplier Quality activities associated with external suppliers. This role performs activities to ensure West supplier’s maintain compliance with West’s procedures and policies. You will interface with R&D, Sourcing, Design Quality, Regulatory and Operations Quality to drive improved supplier quality performance.

Essential Duties and Responsibilities

Establish and successfully execute supplier management plans which will align to overall business objectives

Maintain a strong collaborative partnership with external suppliers and cross-functional team members that facilitates organizational success for assuring high product quality and meeting business needs

Additional Responsibilities

Monitor supplier performance including incoming failures, manufacturing yields and field failures to drive Supplier Corrective Action Reports (SCARs)

Execute Supplier Corrective Action Requests (SCAR) with suppliers, ensuring effective and timely closure

Work with suppliers, R&D, and Sourcing on continuous improvement of supplier performance including supplier change request.

Evaluate potential new or future suppliers and support supplier selection process with the cross-functional team

Participate in cross-functional teams of design engineering and quality engineering to work with suppliers during product development and ensures agreement for manufacturable, cost-effective designs

Approves components for use in products by driving Product Approval activities with the suppliers

Supports Supplier evaluation, audit management and related records

Supports the evaluation and development of Quality Agreements and purchasing specifications with suppliers

Support the development of an Incoming Inspection strategy on purchased products

Education

Bachelor's Degree in Science or equivalent experience required

Master's Degree in Science or equivalent experience preferred

Work Experience

Minimum 5 years of quality related experience with preferred experience in pharmaceutical and/or medical device industry 

Experience working with suppliers and supplier engagement activities

Preferred Knowledge, Skills and Abilities

Knowledge of sterilization process is preferred

Knowledge of cGMP, cGDP, relevant ISO standards, medical device requirements and other international regulations 

Familiarity with MasterControl, SAP and working knowledge of statistical data analysis 

Fluent in English 

Thorough understanding of validation activities and risk management principles and techniques 

Strong problem-solving and critical thinking skills 

Negotiation skills and collaborating with suppliers 

Ability to work under high volume production and fast changing environment 

Willingness to work in a cross-functional team with different time zones 

Able to comply with the company’s safety policy at all times. #LI-AP1 #LI-HYBRID

Travel Requirements

20%: Up to 52 business days per year

Physical Requirements

Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. 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.