Sr Specialist, Supplier Quality

West Pharmaceutical Services; Le Nouvion-en-Thiérache; Sur place; EUR 52 000 - 66 000; Plein temps

Résumé du poste

West Pharmaceutical Services in Le Nouvion-en-Thiérache, France seeks a Sr Assoc, Quality Assurance to oversee QA projects, maintain processes and address quality issues. The role collaborates with suppliers and cross-functional teams to ensure product quality and regulatory compliance.

Required are a Bachelor’s in engineering/science and 5+ years in quality in pharma/medical devices, with English fluency and knowledge of MasterControl and SAP. Travel up to 20% may be involved.

Qualifications

• Bachelor's degree in engineering or science required; master’s preferred.
• Minimum 5 years in quality with pharma/medical device exposure.
• Familiar with cGMP/cGDP, ISO standards and risk management.

Responsabilités

• Establish and execute supplier management plans aligned to business goals.
• Collaborate with suppliers and cross-functional teams to assure high quality.
• Monitor supplier performance and drive SCARs when needed.
• Support supplier evaluation and qualification with cross-functional teams.
• Participate in design and development to ensure manufacturability and cost-effectiveness.
• Approve components via Production Part Approval with suppliers.
• Support quality agreements and improvement of internal supplier processes.

Connaissances

Quality assurance

Vendor management

Analytical thinking

English proficiency

Formation

Bachelor's degree in engineering or science

Master's degree preferred

Outils

MasterControl

SAP

Description du poste

Description 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?

Description 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

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

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.

Pay Transparency

The annual base salary range for this position is €52,100.00 - €66,200.00. Total target compensation is determined using objective and gender‑neutral criteria, including relevant experience, qualifications, skills, market benchmarks, geographic location, and the scope and responsibilities of the role. This position may be eligible for variable compensation and other incentive programs in accordance with the terms of the applicable plans within the country of employment. In addition, team members are eligible to participate in the company’s benefits and total rewards programs applicable to their location and employment status.

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.