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Quality Assurance Manager (m/f/d)
Coriolis Pharma Research GmbH
Planegg, Martinsried
GMP
Qualitätsmanagement
CAPA
Purpose of your Job
As a QA Manager at Coriolis Pharma, you’ll be at the forefront of maintaining and enhancing our GMP-based Quality Management System (QMS), a cornerstone of our commitment to quality. In this role, you will ensure that quality processes are meticulously operated, continuously improved, and aligned with top industry standards. By leading impactful quality projects, you’ll cultivate a culture of excellence, working closely with both internal teams and external consultants to foster innovation and ensure compliance. Your expertise will be essential in embedding and upholding GMP principles, safeguarding the integrity of all operations, and supporting Coriolis Pharma’s reputation for quality and reliability within the GMP business unit.Quality Assurance Manager (m/f/d)
- Parental leave coverThis position is a limited parental leave substitution for 12-18 months.
Your Responsibility
- Manage the life cycle of quality documents, in our electronic document management system and take care of the administration and archiving of paper-based records.
- Plan, coordinate, and conduct employee training programs to maintain high-quality standards of GMP.
- Serve as a role model for the core values of our quality culture.
- Maintain, administrate and further develop our electronic quality management system (Scilife eQMS)
- Manage deviations, CAPA, change control, out-of-specification (OOS) events, and customer complaints.
- Organize and participate in internal and external audits, as well as authority inspections.
- Contribute to quality risk management and continuous improvement activities.
- Perform quality oversight of our GMP-relevant suppliers and service providers.
- Review and approve quality documents and records.
- Support the GMP analytical team and the IT department in quality related matters.
What you need to succeed
- Degree in Life Sciences, Pharmacy, or a vocational training in related fields
- 2+ years of experience in Quality Assurance within a GMP-regulated pharmaceutical or biotech environment.
- In-depth knowledge of GMP guidelines and regulations relevant for analytical laboratories.
- Expertise in computerized system validation (CSV) and GAMP is a plus.
- Experience in the management and administration of eQMS.
- Experience with internal and external audits. Experience with regulatory inspections (e.g., FDA, EMA) is a plus.
- Business fluency in both German and English, with excellent communication and documentation skills.
- Didactical skills and enjoy onboarding and mentoring analytical staff in the GMP environment.
- Strong skills in organization/planning
- Expertise in quality and risk management tools like root cause analysis, FMEA, etc.
- Open-minded, friendly and assertive personality.
- Affinity to new technologies and IT skills is a strong plus.
Why to join Coriolis?
Let’s formulate innovation together…
Our success & development is created by the people working together @Coriolis.
We put People first! That’s why we have a growth mindset, and value personality, collaboration and community to create an empowering and inspiring working space with focus on quality and clients.
We would like to grow together with you!
Let’s continue building and creating the future now, join our team of currently around 200 employees. In a highly motivated and interdisciplinary team, we provide you with a great chance to increase your experience.
We offer an attractive work space at the Martinsried site. Let’s make a difference together!
Coriolis Pharma is an equal opportunity employer and welcomes applications from all qualified individuals regardless of ethnicity, sex, citizenship or gender identity, color, disability, religion/belief, romantic orientation, marital status, age or individual preferencies. Different backgrounds, experiences and ideas push us further and raise the bar.
Thank you for your interest! We look forward to receiving your application documents.
Please use our career portal exclusively for this purpose.
We would like to support you from the very beginning to shape your development possibilities here at Coriolis.
For questions or further information, please visit our website or contact us directly.
Invest in yourself
Our success & development is created by the people working together @Coriolis.
We put People first! That’s why we have a growth mindset, and value personality, collaboration and community to create an empowering and inspiring working space with focus on quality and clients.
We would like to grow together with you!
Let’s continue building and creating the future now, join our team of currently around 200 employees. In a highly motivated and interdisciplinary team, we provide you with a great chance to increase your experience.
We offer an attractive work space at the Martinsried site. Let’s make a difference together!
Coriolis Pharma is an equal opportunity employer and welcomes applications from all qualified individuals regardless of ethnicity, sex, citizenship or gender identity, color, disability, religion/belief, romantic orientation, marital status, age or individual preferencies. Different backgrounds, experiences and ideas push us further and raise the bar.
Thank you for your interest! We look forward to receiving your application documents.
Please use our career portal exclusively for this purpose.
We would like to support you from the very beginning to shape your development possibilities here at Coriolis.
For questions or further information, please visit our website or contact us directly.
Invest in yourself
- Ownership: All team members are empowered to bring ideas, make decisions and have impact. Participate in our equity program and share in our success.
- Transparency: Everyone at Coriolis is regularly updated on strategic progress, KPI tracking, product updates and changes.
- Growth: Not only will you grow in your role, you also have access to our people development budget.
- Flexibility: Work on your terms, by leveraging our hybrid-office arrangement. No minimums or maximums
Your Contact
Dominik Schwemmer
Senior Business Partner - Talent & Development
People, Organization & Culture Unit
Coriolis Pharma Research GmbH
Phone: +49 (0) 89 - 417760 - 0
Fraunhoferstraße 18 b, 82152 Martinsried
www.coriolis-pharma.com
About us
Coriolis Pharma, is a globally operating service provider and one of the world leaders in formulation research and development of (bio)pharmaceutical drugs and vaccines.We revolutionize the development process of biopharmaceutical drugs by integrating innovative digital formulation approaches from drug development to commercial products.
As a people and team-oriented company with an interdisciplinary team of highly skilled scientists and an expert scientific advisory board, we provide cutting-edge services and tailor-made solutions for our clients.
Our company culture is based on diversity, teamwork and open and appreciative communication. That's why wonderful people from over 35 nations around the world work together successfully at Coriolis.
What motivates us? Our motivation is to enable the development of innovative drugs by performing outstanding biopharmaceutical research to improve the quality of life for humankind.
We are looking forward to your application!
Full-Time
, Temporary
Specialist
Updated at
11/04/2024
While applying for the job please refer to jobvector
Workplace
Job location
Fraunhoferstr. 18b
82152 Planegg
Bavaria
Germany
Good to reach from...
- München
- Augsburg
- Freising
- Dachau
- Germering, Oberbayern
- Fürstenfeldbruck
Salary
The stated amount is the estimated average gross annual salary for comparable full-time positions.
€ 67,801
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About Coriolis Pharma Research GmbH
About us
Coriolis Pharma, is a globally operating independent service provider for formulation research and development of (bio)pharmaceutical drugs (proteins, peptides, monoclonal antibodies, RNA/DNA etc.) and vaccines. An interdisciplinary team of highly qualified scientists with many years of experience in the development of (bio)pharmaceuticals supported by an expert scientific advisory...
More about Coriolis Pharma Research GmbH