Randstad Professional
51465 Bergisch Gladbach - Deutschland
Fachkraft - Qualitätssicherung/-management
Arbeit
Vollzeit
ab 02.02.2026
Beschreibung
Randstad is one of the world's leading talent companies with the
ambition to be the world's most equitable and specialized talent
company. Through our "partner for talent" corporate strategy, we find,
develop and connect specialized talents with companies - worldwide,
locally and always at a high speed. We build high-quality, diverse,
and agile teams, while individuals can enjoy a rewarding career path
with equitable opportunities.
Randstad Professional is one of Randstad's four sp... weiter lesen
ambition to be the world's most equitable and specialized talent
company. Through our "partner for talent" corporate strategy, we find,
develop and connect specialized talents with companies - worldwide,
locally and always at a high speed. We build high-quality, diverse,
and agile teams, while individuals can enjoy a rewarding career path
with equitable opportunities.
Randstad Professional is one of Randstad's four sp... weiter lesen
Randstad is one of the world's leading talent companies with the
ambition to be the world's most equitable and specialized talent
company. Through our "partner for talent" corporate strategy, we find,
develop and connect specialized talents with companies - worldwide,
locally and always at a high speed. We build high-quality, diverse,
and agile teams, while individuals can enjoy a rewarding career path
with equitable opportunities.
Randstad Professional is one of Randstad's four specializations
and focuses on the placement of specialists and managers in the
future-oriented sectors of IT, Engineering, Life Science and Office.
Currently we are looking for a Manager QA for Commercial Manufacturing
– ATMP (m/w/d) for a freelance project of up to 6 months at our
customer Miltenyi Biotec in Bergisch Gladbach. This hybrid role offers
the opportunity to lead QA activities for commercial Cell and Gene
Therapy products, ensuring compliance with international GxP
standards, driving continuous improvement, and collaborating with
cross-functional teams in a dynamic, innovative environment.
We look forward to receiving your application!
- Ensure inspection readiness from a QA perspective, collaborating
with operational departments, project managers, and other QA teams.
Continuously monitor commercial manufacturing and implement tools for
GxP compliance.
- Guarantee that all manufacturing operations meet applicable quality
standards and regulations (GxP, EU Guidelines, 21 CFR). Maintain RA &
GMP compliance and assess new regulatory requirements.
- Prepare, review, and approve quality documents such as batch
records, SOPs, test procedures, and risk assessments. Drive continuous
improvement of GMP compliance and quality systems within the Cell
Factory.
- Align QA topics across Cell Factories within Miltenyi. Foster
transparent communication and trustworthy information exchange between
QA, operational departments, and external partners.
- Implement measures to eliminate gaps and audit deficiencies, track
related actions, and support decentralized manufacturing and
point-of-care approaches for CGT.
- Act as primary contact for external support activities, drive
QA-related decision-making, and support employee qualification
monitoring and participation.
- Degree in Pharmacy, Biology, Biochemistry, or Medicine, with
several years of experience in the commercial pharmaceutical industry.
- Solid experience across various QA functions and strong knowledge
of international and national cGxP regulations and the regulatory
environment.
- Familiarity with aseptic processes and Cell & Gene Therapy (CGT);
knowledge of development requirements and GCP regulations is a plus.
- Experience preparing for and hosting inspections by local and
international health authorities (e.g., EU, FDA).
- Strong skills in critical communication, managing multiple GMP
topics simultaneously, and proactively identifying risks with
effective mitigation strategies.
- Fluent in English and German (spoken and written), with excellent
presentation skills, a structured working style, and an analytical
mindset.
- Attractive options for shortening your personal payment term
- No more time-consuming invoicing
- Fast, reliable payment of fees
- Conclude project contracts by means of electronic signature
ambition to be the world's most equitable and specialized talent
company. Through our "partner for talent" corporate strategy, we find,
develop and connect specialized talents with companies - worldwide,
locally and always at a high speed. We build high-quality, diverse,
and agile teams, while individuals can enjoy a rewarding career path
with equitable opportunities.
Randstad Professional is one of Randstad's four specializations
and focuses on the placement of specialists and managers in the
future-oriented sectors of IT, Engineering, Life Science and Office.
Currently we are looking for a Manager QA for Commercial Manufacturing
– ATMP (m/w/d) for a freelance project of up to 6 months at our
customer Miltenyi Biotec in Bergisch Gladbach. This hybrid role offers
the opportunity to lead QA activities for commercial Cell and Gene
Therapy products, ensuring compliance with international GxP
standards, driving continuous improvement, and collaborating with
cross-functional teams in a dynamic, innovative environment.
We look forward to receiving your application!
- Ensure inspection readiness from a QA perspective, collaborating
with operational departments, project managers, and other QA teams.
Continuously monitor commercial manufacturing and implement tools for
GxP compliance.
- Guarantee that all manufacturing operations meet applicable quality
standards and regulations (GxP, EU Guidelines, 21 CFR). Maintain RA &
GMP compliance and assess new regulatory requirements.
- Prepare, review, and approve quality documents such as batch
records, SOPs, test procedures, and risk assessments. Drive continuous
improvement of GMP compliance and quality systems within the Cell
Factory.
- Align QA topics across Cell Factories within Miltenyi. Foster
transparent communication and trustworthy information exchange between
QA, operational departments, and external partners.
- Implement measures to eliminate gaps and audit deficiencies, track
related actions, and support decentralized manufacturing and
point-of-care approaches for CGT.
- Act as primary contact for external support activities, drive
QA-related decision-making, and support employee qualification
monitoring and participation.
- Degree in Pharmacy, Biology, Biochemistry, or Medicine, with
several years of experience in the commercial pharmaceutical industry.
- Solid experience across various QA functions and strong knowledge
of international and national cGxP regulations and the regulatory
environment.
- Familiarity with aseptic processes and Cell & Gene Therapy (CGT);
knowledge of development requirements and GCP regulations is a plus.
- Experience preparing for and hosting inspections by local and
international health authorities (e.g., EU, FDA).
- Strong skills in critical communication, managing multiple GMP
topics simultaneously, and proactively identifying risks with
effective mitigation strategies.
- Fluent in English and German (spoken and written), with excellent
presentation skills, a structured working style, and an analytical
mindset.
- Attractive options for shortening your personal payment term
- No more time-consuming invoicing
- Fast, reliable payment of fees
- Conclude project contracts by means of electronic signature
Ref-Nr.: 8861298
Aktualisiert:
25.01.2026
Quelle: Bundesagentur für Arbeit
weitere Infos Rechtliche Hinweise zur Nutzung
Ob die Stelle noch verfügbar ist und weitere Informationen findest du direkt auf der Website der Bundesagentur für Arbeit. Bitte beachte: OPROMA ist nicht der Anbieter dieser Stelle und kann keine Auskünfte geben.
weitere Infos Rechtliche Hinweise zur Nutzung
Ob die Stelle noch verfügbar ist und weitere Informationen findest du direkt auf der Website der Bundesagentur für Arbeit. Bitte beachte: OPROMA ist nicht der Anbieter dieser Stelle und kann keine Auskünfte geben.
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