SUSONITY
Operational Excellence Quality Lead(m/w/x)
Full-time/Part-timeOn-siteSenior
Darmstadt
New Job?Nejo!
The AI Job Search Engine
SUSUSONITY
Head of Site Quality Life Science Operations(m/w/x)
Darmstadt
Full-timeOn-siteSenior
Nejo AI Summary
Quality assurance for Life Science Operations portfolio production, managing a team of 400. Extensive GMP, FDA, and health authority inspection experience required. 4-day work week, company car for private use.
Requirements
- Scientific degree in natural sciences, chemistry, pharmacy, or engineering
- Excellent GMP regulation knowledge
- Practical FDA and health authority inspection experience
- Experience leading large teams of managers and specialists
- Strong problem-solving skills
- Robust analytical abilities
- Qualification as Lean & Six Sigma Black Belt
- Proven experience managing change processes
- Ability to lead large teams in production
- Ability to create motivating work environment
- Solid knowledge of modern production systems
- Experience building autonomous teams
- Promoting continuous improvements
- Capabilities in identifying improvement opportunities
- Capabilities in analyzing improvement opportunities
- Excellent verbal communication skills
- Excellent written communication skills
- Ability to process scientific information
- Ability to process quality information
- Ability to process regulatory information
- Ability to communicate scientific information
- Ability to communicate quality information
- Ability to communicate regulatory information
- Good understanding of life science market
- Understanding of pharmaceutical manufacturing
- Understanding of pharmaceutical distribution
Tasks
- Ensure quality assurance and management of product range
- Lead a large quality team (approx. 400 employees)
- Ensure products meet highest quality standards
- Lead and coordinate team for Life Science Operations portfolio production
- Ensure compliance with legal and internal standards (ICH Q7, EXCiPACT, ISO 13485, ISO 17025, ISO 17034, ISO 9001)
- Develop and implement quality strategies, policies, and procedures
- Identify areas for improvement within the QMS
- Collaborate with stakeholders, authorities, and customers on product quality
- Cooperate with management on strategic organizational goals and plans
- Manage quality assurance and control of raw materials, intermediates, and finished products
- Implement strategies for employee involvement in decision-making and continuous improvement
- Foster a culture of trust and open communication
Work Experience
- 10 years
Education
- Bachelor's degree
Languages
- German – Native
Tools & Technologies
- GMP
- FDA
- Lean Management
- Six Sigma
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of SUSONITY 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.
Not a perfect match?
- Döhler
Head of Group Third Party Manufacturing(m/w/x)
Full-timeOn-siteSeniorDarmstadt - Bayer
GMP Validation and Qualification Expert(m/w/x)
Full-timeOn-siteSeniorDarmstadt - MSK Pharma Group
Mitarbeiter im Qualitätsmanagement(m/w/x)
Full-timeOn-siteJuniorBensheim - Döhler
Manager Group Quality Management Systems(m/w/x)
Full-timeOn-siteManagementDarmstadt
SUSUSONITY
Head of Site Quality Life Science Operations(m/w/x)
Darmstadt
Full-timeOn-siteSenior
Nejo AI Summary
Quality assurance for Life Science Operations portfolio production, managing a team of 400. Extensive GMP, FDA, and health authority inspection experience required. 4-day work week, company car for private use.
Requirements
- Scientific degree in natural sciences, chemistry, pharmacy, or engineering
- Excellent GMP regulation knowledge
- Practical FDA and health authority inspection experience
- Experience leading large teams of managers and specialists
- Strong problem-solving skills
- Robust analytical abilities
- Qualification as Lean & Six Sigma Black Belt
- Proven experience managing change processes
- Ability to lead large teams in production
- Ability to create motivating work environment
- Solid knowledge of modern production systems
- Experience building autonomous teams
- Promoting continuous improvements
- Capabilities in identifying improvement opportunities
- Capabilities in analyzing improvement opportunities
- Excellent verbal communication skills
- Excellent written communication skills
- Ability to process scientific information
- Ability to process quality information
- Ability to process regulatory information
- Ability to communicate scientific information
- Ability to communicate quality information
- Ability to communicate regulatory information
- Good understanding of life science market
- Understanding of pharmaceutical manufacturing
- Understanding of pharmaceutical distribution
Tasks
- Ensure quality assurance and management of product range
- Lead a large quality team (approx. 400 employees)
- Ensure products meet highest quality standards
- Lead and coordinate team for Life Science Operations portfolio production
- Ensure compliance with legal and internal standards (ICH Q7, EXCiPACT, ISO 13485, ISO 17025, ISO 17034, ISO 9001)
- Develop and implement quality strategies, policies, and procedures
- Identify areas for improvement within the QMS
- Collaborate with stakeholders, authorities, and customers on product quality
- Cooperate with management on strategic organizational goals and plans
- Manage quality assurance and control of raw materials, intermediates, and finished products
- Implement strategies for employee involvement in decision-making and continuous improvement
- Foster a culture of trust and open communication
Work Experience
- 10 years
Education
- Bachelor's degree
Languages
- German – Native
Tools & Technologies
- GMP
- FDA
- Lean Management
- Six Sigma
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of SUSONITY 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.
About the Company
SUSONITY
Industry
Science
Description
Das Unternehmen entwickelt Medikamente, intelligente Geräte und innovative Technologien in Therapiegebieten wie der Onkologie, Neurologie und Fruchtbarkeit.
Not a perfect match?
- SUSONITY
Operational Excellence Quality Lead(m/w/x)
Full-time/Part-timeOn-siteSeniorDarmstadt - Döhler
Head of Group Third Party Manufacturing(m/w/x)
Full-timeOn-siteSeniorDarmstadt - Bayer
GMP Validation and Qualification Expert(m/w/x)
Full-timeOn-siteSeniorDarmstadt - MSK Pharma Group
Mitarbeiter im Qualitätsmanagement(m/w/x)
Full-timeOn-siteJuniorBensheim - Döhler
Manager Group Quality Management Systems(m/w/x)
Full-timeOn-siteManagementDarmstadt