Dein persönlicher KI-Karriere-Agent
Head of Site Quality Life Science Operations(m/w/x)
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 10 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Deutsch – fließend
Tools & Technologien
- GMP
- FDA
- Lean Management
- Six Sigma
Noch nicht perfekt?
- SUSONITYVollzeit/Teilzeitnur vor OrtSeniorDarmstadt
- Döhler
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Head of Site Quality Life Science Operations(m/w/x)
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 10 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Deutsch – fließend
Tools & Technologien
- GMP
- FDA
- Lean Management
- Six Sigma
Über das Unternehmen
SUSONITY
Branche
Science
Beschreibung
Das Unternehmen entwickelt Medikamente, intelligente Geräte und innovative Technologien in Therapiegebieten wie der Onkologie, Neurologie und Fruchtbarkeit.
Noch nicht perfekt?
- SUSONITY
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GMP Validation and Qualification Expert(m/w/x)
Vollzeitnur vor OrtSeniorDarmstadt - MSK Pharma Group
Mitarbeiter im Qualitätsmanagement(m/w/x)
Vollzeitnur vor OrtJuniorBensheim - Döhler
Head of Group Supply Chain Management(m/w/x)
Vollzeitnur vor OrtSeniorDarmstadt