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Associate Director TSMS Sterility Assurance(m/w/x)
Leading technical investigations and evaluations for life-changing medicines at a global pharmaceutical developer. 7+ years in medical device industry and 3+ years leadership experience required. Excellent company pension plan.
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
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
Work Experience
- 7 years
Education
- Bachelor's degreeOR
- Master's degree
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
Not a perfect match?
- 350 Lilly Deutschland GmbHFull-timeOn-siteManagementAlzey
- 350 Lilly Deutschland GmbH
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Associate Director TSMS Sterility Assurance(m/w/x)
Leading technical investigations and evaluations for life-changing medicines at a global pharmaceutical developer. 7+ years in medical device industry and 3+ years leadership experience required. Excellent company pension plan.
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
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
Work Experience
- 7 years
Education
- Bachelor's degreeOR
- Master's degree
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
About the Company
350 Lilly Deutschland GmbH
Industry
Healthcare
Description
The company is a global healthcare leader dedicated to discovering and bringing life-changing medicines to those in need.
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