Sr Specialist, Supplier Quality

West Pharmaceutical Services

Le Nouvion-en-Thiérache, France

Job Summary

The Sr Assoc, Quality Assurance oversees projects, maintains processes and addresses quality issues by analyzing outcomes and collaborating with teams for effective resolutions. This position will continue the QA routine activities of a working WSS lab and QA duties for future business.

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
Monitor supplier performance including incoming failures, manufacturing yields and field failures to drive Supplier Corrective Action Reports (SCARs)
Work with suppliers, design engineers, supplier quality and purchasing on continuous improvement of supplier performance
Evaluate potential new or future suppliers and supports 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
Approve components for use in products by driving Production Part Approval activities with the suppliers
Support Supplier evaluation, audit management and related records
Support the evaluation and development of Quality Agreements with suppliers
Support the improvement efforts on internal supplier processes

Education

Bachelor's Degree In Engineering or Science required and
Master's Degree In Engineering or Science 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
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