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350 Lilly Deutschland GmbH
2mo ago

Associate Director TSMS Sterility Assurance(m/w/x)

Alzey
Full-timeOn-siteManagement

Description

In this role, you will focus on enhancing sterility assurance by leading investigations, developing compliance strategies, and serving as a key contact during audits. Your expertise will help ensure the highest quality standards are met.

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Requirements

  • •Bachelor’s degree in science, engineering, management, pharmacist PhD, or related field
  • •7+ years of experience in the medical device industry
  • •Minimum of 3 years of leadership experience
  • •Solid understanding of regulatory agency requirements
  • •Strong leadership skills
  • •Teamwork skills
  • •Problem-solving skills
  • •Adaptability and passion
  • •Proficiency in German and English
  • •Willingness to work at the Alzey site
  • •Openness to international travel

Education

Bachelor's degree
OR
Doctoral / PhD
OR
Master's degree

Work Experience

7 years

Tasks

  • •Develop and maintain expertise in sterility assurance
  • •Conduct technical investigations and evaluations
  • •Lead sterility assurance improvement projects
  • •Evaluate and decide on technical solutions during projects
  • •Define and validate on-site sterility assurance strategies
  • •Ensure compliance with regulations and quality policies
  • •Report quality issues and inspection risks to leadership
  • •Participate in regulatory inspections and audits
  • •Serve as the primary contact for sterility assurance matters
  • •Develop and implement environmental monitoring sampling strategy
  • •Manage the site contamination control strategy

Languages

German – Business Fluent

English – Business Fluent

Benefits

Retirement Plans

  • •Excellent company pension plan

Other Benefits

  • •Individual benefits

Career Advancement

  • •Career development opportunities

Learning & Development

  • •Access to Lilly University
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of 350 Lilly Deutschland GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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