Senior Manager Supplier Quality

Location: Netherlands

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!

THE COMPANY

Our client is a professional Medical Devices organization, based in Noord-Holland Netherlands.

is a major American developer, manufacturer and reseller of Medical Devices

ROLE DESCRIPTION

You will take ownership for the strategic planning and management of supplier compliance activities with management responsibilities over multiple sites.
You will have to develop, establish and maintain supplier quality business processes, engineering methodologies, and practices
To serve as a Quality representative to improve awareness, visibility, and communication on quality initiatives supporting departmental, functional, site, divisional and corporate quality goals and priorities. You will act as the key interface with site operations as it pertains to Supplier Quality Issues.
Demonstrate a primary commitment to patient safety, product quality and compliance with the company and its governing regulations.
Investigate, identify, and implement best-in-class Quality Engineering practices across the Supplier Quality.
Provide technical guidance mentoring for identifying and resolving quality issues.
Identify and communicate to Quality leadership issues that impact product quality, safety or efficacy, regulatory compliance or business continuity which have arisen from a supplier. Identify and continually improve effective processes and systems to support Supplier Quality.
Project management and leadership in the implementation of new requirements (regulatory, corporate and local) for the quality systems managed.
Responsible for ensuring key site representation at external regulatory body audits – SME SQ.
Ownership of key performance metrics and monitoring for areas managed
Provide RHQ Quality and Operations Management with periodical supplier quality performance assessment and KPI’s of each Supplier
Provide SME input to enable risk to be assessed and as an input to the quality planning process.

RESPONSIBILITIES

- Develop, plan, approve, manage and continually assess the supplier quality compliance activities and its tactical execution by the Supplier quality compliance teams.
- Ensure continuous quality compliance through quality improvement program for the supplier base.
- Leverage greater efficiencies in the supplier compliance group by developing and applying standardised/harmonised methodologies to the quality activity management and ensure tactical execution at the manufacturing sites.
- Drive effective closure of NC’s and CAPA’s, by mentoring and coaching NC/CAPA owners to ensure comprehension, development, and execution of corrective/preventive action with regards to any nonconformity cited.
- Ensure the supplier compliance program adapts to changes to both internal and external quality requirements.
- Conduct and support quality benchmarking activities.
- Identify areas of opportunity and support continual improvement of ONV Quality and work with the relevant groups on how these can be improved.
- Collaborate with the co-ordination of external body audit activities at the manufacturing sites as pertains to supplier interaction.
- Create and foster a strong working relationship with the different Global Supplier Quality functions, Global Quality, Strategic Sourcing and additional key interfaces to facilitate effective collaboration.
- Actively develop the team’s expertise and team dynamics through continuous coaching, promoting development programmes and formal appraisals through the performance review process.

REQUIREMENTS

- Bachelor’s degree in Science, Engineering or related subject.
- 8+ years relevant quality experience in GMP manufacturing environment in Medical Device, Pharma, Automotive or Aerospace industry.
- Thorough knowledge of current regulations, pertinent regulatory guidance and industry trends.
- An understanding of the technical aspects of the areas – understand the process, operational terminology etc.
- Experience in quality management systems is essential.
- Must possess strong communication, project management and leadership skills as well as have the ability to manage multiple projects simultaneously
- Strong interpersonal skills, strong leadership skills, strong written and oral communication and negotiations skills.
- Highly developed problem solving skills.
- Strong analytical skills.
- Demonstrated ability to successfully manage and complete projects in a matrix organization.
- Demonstrated ability to lead cross-functional teams.
- Demonstrated ability to work independently.
- Demonstrated knowledge of U.S. FDA regulations, as well as of European and international regulatory/industry guidelines/standards, and ability to interpret and apply.
- Travel required 40-50%.​

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Tim Thuijs.