Manager QA for Commercial Manufacturing ATMP (m|f|d)

Bergisch Gladbach - Germany

Monthly Salary: Not Disclosed

Posted on: 15 hours ago

Vacancies: 1 Vacancy

Job Summary

As a Manager QA for Commercial Manufacturing ATMP you will responsible for Commercial Cell and Gene Therapy Products manufactured within Cell Factory in Bergisch Gladbach.

Your main responsibilities include:

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 820.20b.3). 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.

Qualifications :

You hold a degree in Pharmacy Biology Biochemistry or Medicine and have several years of experience in the commercial pharmaceutical industry.
You bring solid experience across various QA functions and possess strong knowledge of international and national cGxP regulations and the regulatory environment.
You are familiar with aseptic processes and Cell & Gene Therapy (CGT). Knowledge of development requirements and GCP regulations is a plus.
You have experience preparing for and hosting inspections by local and international health authorities (e.g. EU FDA).
You excel in critical communication managing multiple GMP topics simultaneously and proactively identifying risks while proposing effective mitigation strategies.
You are fluent in English and German (spoken and written) with excellent presentation skills a structured working style and an analytical mindset.

Zusätzliche Informationen :

Diversity: International teams and cross-border intercultural communication
Room for creativity: Its the most clever solution that we always strive for
Health & Sport: Corporate sports activities and health provision
Miltenyi University: A clever mind never stops learning take advantage of our inhouse Training Academy
Corporate benefits: Employee events 30 days of vacation (e)-bike leasing company pension plan and many other offers

Diversity is the bedrock of our creativity.

Our mission: To innovate treatments and technologies and tackle the worlds most serious health challenges. And thats why we connect the dots across various disciplines linking different perspectives skills and abilities.

You and your talent are welcome here in our inclusive and collaborative environment. So come as you are. Regardless of gender sexual identity age ethnicity religion or disability.

Contact us

If you are passionate about the purpose of your code and enjoy working in a supportive team culture then please do not hesitate to join us in our great vision and make a real difference to peoples lives.

Remote Work :

Employment Type :

Full-time

As a Manager QA for Commercial Manufacturing ATMP you will responsible for Commercial Cell and Gene Therapy Products manufactured within Cell Factory in Bergisch Gladbach.Your main responsibilities include:Ensure inspection readiness from a QA perspective collaborating with operational departments p...

As a Manager QA for Commercial Manufacturing ATMP you will responsible for Commercial Cell and Gene Therapy Products manufactured within Cell Factory in Bergisch Gladbach.

Your main responsibilities include:

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 820.20b.3). 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.

Qualifications :

You hold a degree in Pharmacy Biology Biochemistry or Medicine and have several years of experience in the commercial pharmaceutical industry.
You bring solid experience across various QA functions and possess strong knowledge of international and national cGxP regulations and the regulatory environment.
You are familiar with aseptic processes and Cell & Gene Therapy (CGT). Knowledge of development requirements and GCP regulations is a plus.
You have experience preparing for and hosting inspections by local and international health authorities (e.g. EU FDA).
You excel in critical communication managing multiple GMP topics simultaneously and proactively identifying risks while proposing effective mitigation strategies.
You are fluent in English and German (spoken and written) with excellent presentation skills a structured working style and an analytical mindset.

Zusätzliche Informationen :

Diversity: International teams and cross-border intercultural communication
Room for creativity: Its the most clever solution that we always strive for
Health & Sport: Corporate sports activities and health provision
Miltenyi University: A clever mind never stops learning take advantage of our inhouse Training Academy
Corporate benefits: Employee events 30 days of vacation (e)-bike leasing company pension plan and many other offers

Diversity is the bedrock of our creativity.

You and your talent are welcome here in our inclusive and collaborative environment. So come as you are. Regardless of gender sexual identity age ethnicity religion or disability.

Contact us

Remote Work :

Employment Type :

Full-time

Key Skills

Lean Manufacturing
Six Sigma
Continuous Improvement
ISO 9001
Lean Six Sigma
Management Experience
Manufacturing & Controls
5S
Manufacturing Management
Kaizen
Chemistry
Manufacturing

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About Company

Miltenyi Biotec

For over 30 years, Miltenyi Biotec has been a major provider of products and services that drive biomedical research and boost cell and gene therapy. More than 4,700 employees in 23 countries combine excellence in research with innovative products to create cutting-edge solutions that ... View more

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