Actarmo Medical GmbH Greater Munich Metropolitan Area
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ACTARMO is a Contract Research Organization (CRO) specialized in respiratory products. We partner with pharmaceutical, biopharmaceutical, and device companies, offering expert support in portfolio and regulatory strategy, MDR consultancy, pharmaceutical development, and analytical services, all the way to regulatory approval.
We're on the lookout for a
HEAD OF QUALITY CONTROL (m/f/d)
Join our team! As the Head of Quality Control, you'll play a pivotal role in our growth and client satisfaction. Enjoy a supportive team and exciting projects.
Your Responsibilities:
1. Lead and manage the Quality Control department, both functionally and disciplinarily
2. Oversee the department's budget
3. Ensure activities comply with AMWHV §12, pharmaceutical regulations, and relevant legal standards (including EMA and FDA)
4. Maintain GMP compliance in all laboratory aspects
5. Manage risk, deviations, changes, CAPA, qualification, and analytical method validation within Quality Control
6. Develop and maintain internal test instructions, methods, and other quality control procedures
7. Coordinate and monitor external contract analysis laboratories
8. Participate in internal and external audits and inspections
Your Profile:
1. Extensive experience in analytics and quality control within a GMP environment
2. At least 5 years of hands-on experience in pharmaceutical testing or manufacturing
3. Proven leadership skills with experience managing teams of 5 to 15 people
4. Expertise in instrumental analysis and wet chemical methods, such as HPLC, photometry, and titration
5. Familiarity with GMP, ICH, EMA, and FDA guidelines for inhalation drug product testing and approval
6. Strong knowledge of the German Drug Law (AMG) and German Drug and Drug Substance Act (AMWHV)
7. Experience with handling of narcotics in an analytical laboratory is a plus
We're excited to receive your application! We make hiring decisions based on qualifications, without regard to gender, ethnicity, religion, or age.
Send your application to:
Actarmo Medical GmbH, Robert-Koch-Allee 29, 82131 Gauting, or info@actarmo.com
Seniority level
Director
Employment type
Full-time
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