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Senior Manager (m/f/d) Quality Systems - mit Führungsverantwortung (DE)
[6066]
Our client is one of the leading, research-based, globally active bio-pharmaceutical companies, which has focused on the development of therapies for the treatment of some of the world's most complex diseases. Our client is a successful global player in the development, research and distribution of innovative medicines. Around 50,000 employees worldwide work to research, develop and bring to market innovative, scientific solutions to meet the greatest health challenges of today and tomorrow. For the next possible date we are looking for a committed personality as a Senior Manager (m/f/d) Quality Systems leadership responsibility Your tasks ·Lead the respective QA Groups: Audits/Inspection, Training, Documentation, Supplier Controls, Quality Risk Management ·Ensure site compliance with cGMP and applicable ISO regulations (e.g., ISO 13485) ·Own the site’s Quality System-related processes ·Provide leadership for subordinate managers and teams ·Lead internal and external audits and inspections to maintain site GMP compliance, lead inspection readiness activities ·Act as key contact for GxP relevant questions at the site ·Compile, analyze, communicate quality metrics to senior management ·Maintain site training system and ensure it is appropriate and effective, coordinate GMP training Your qualifications ·Master’s degree in Chemistry / Pharmaceutical Chemistry / Pharmacy or equivalent ·8+ years of experience in Pharma industry, preferably drug product ·Minimum 5-year experience in Pharma Quality is an asset ·Sound knowledge of cGMP regulations and agencies’ expectations ·Experience in Pharma inspections ·Experience in Medical Device Quality (desirable) ·Ability to act as Qualified Person according to EU GMP (desirable) ·High degree of self-motivation, proactivity, and efficient results-oriented way of working ·Passionate for process improvement and performance ·Strong leadership skills with minimum 3-year proven track record ·Excellent communication and presentation skills, organizational and motivational talent ·Business fluent, written and spoken, in German and English If you feel attracted by this job feel free to get in touch with Lea Stolle at Optares Medical via lea.stolle@optares.de or by phone under +49 441 21879-42
- Lead the respective QA Groups: Audits/Inspection, Training, Documentation, Supplier Controls, Quality Risk Management
- Ensure site compliance with cGMP and applicable ISO regulations (e.g., ISO 13485)
- Own the site’s Quality System-related processes
- Provide leadership for subordinate managers and teams
- Lead internal and external audits and inspections to maintain site GMP compliance, lead inspection readiness activities
- Act as key contact for GxP relevant questions at the site
- Compile, analyze, communicate quality metrics to senior management
- Maintain site training system and ensure it is appropriate and effective, coordinate GMP training
Your qualifications
- Master’s degree in Chemistry / Pharmaceutical Chemistry / Pharmacy or equivalent
- 8+ years of experience in Pharma industry, preferably drug product
- Minimum 5-year experience in Pharma Quality is an asset
- Sound knowledge of cGMP regulations and agencies’ expectations
- Experience in Pharma inspections
- Experience in Medical Device Quality (desirable)
- Ability to act as Qualified Person according to EU GMP (desirable)
- High degree of self-motivation, proactivity, and efficient results-oriented way of working
- Passionate for process improvement and performance
- Strong leadership skills with minimum 3-year proven track record
- Excellent communication and presentation skills, organizational and motivational talent
- Business fluent, written and spoken, in German and English
If you feel attracted by this job feel free to get in touch with Lea Stolle at Optares Medical via lea.stolle@optares.de or by phone under +49 441 21879-42
Lea Stolle