West Pharma Senior Specialist Supplier Quality Germany, North Rhine – Westphalia 408663949
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.
- 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)
- 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
- Bachelor's Degree in Science or equivalent experience required
- Master's Degree in Science or equivalent experience preferred
- 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 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.
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