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Applications close September 12th, 2026
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Merck

Quality Assurance GMP Compliance Manager

5 day weekGenerous PTOHybrid · Unterschleissheim, Germany

Job Description

Our Quality Assurance department ensures that all materials and substances contained in our products are manufactured, processed, tested, packaged, stored, and delivered in compliance with our strict quality standards and all regulatory requirements. Through the close collaboration of our internal production facilities and cooperation with external manufacturers and suppliers, we create a tightly integrated global production network dedicated to reliably and punctually supplying customers and patients worldwide with products that meet high quality standards in every single case.

To strengthen our operational quality unit at the production site in Unterschleißheim, we are looking for a Quality Assurance GMP Compliance Manager (m/f/d) as soon as possible.

Location: Unterschleißheim (near Munich) | Full-time.

Your Tasks:

  • Independent management of processes in quality systems (e.g., Deviation Management, Complaint Handling, Change Control) and ensuring effective quality management within QA Operations

  • Strategic further development of quality and GMP compliance in operational areas

  • DEPOC for technical topics

  • Ensuring "QA on the shop floor"

  • Guidance and support for production, quality control, and other relevant departments regarding GMP issues within the area of responsibility

  • Support in the further development and continuous improvement of quality-relevant key performance indicators

  • If applicable, taking over a quality system including the creation and further development of quality-relevant SOPs as well as representing the site in the global network

  • Participation in regulatory inspections, supplier evaluations, and, if applicable, participation in audits

  • Support for aseptic validations and training

Your Profile

  • Successfully completed degree in natural sciences or a comparable qualification

  • Initial professional experience in pharmaceutical quality assurance or in the industrial sector, or several years of professional experience in a comparable qualification in a regulated environment with high quality and hygiene requirements

  • Good knowledge of GMP requirements and quality assurance systems

  • Basic knowledge of pharmaceutical manufacturing, aseptic processes, QC analytics, and process engineering

  • Quick grasp of new concepts and the ability to work in a cross-functional team

  • Reliability, result-orientation, stress tolerance, very good communication skills, as well as powers of persuasion and assertiveness

  • Good written and spoken German and English skills as well as Technical Writing skills

The stated goal of our Production & Supply division is to act as the world's most reliable manufacturer and supplier of biopharmaceuticals. Together with our external contractors, suppliers, and partners, our production facilities form a tightly integrated global production network dedicated to reliably and punctually supplying customers and patients with high-quality products in every single case.

We are proud to be a company built on the values of its diverse, talented, and committed employees. The fastest way to drive innovative developments is to bring different ideas together in an inclusive environment. We encourage our colleagues to discuss their ideas objectively and tackle problems together. We see ourselves as an equal opportunity employer and are committed to promoting inclusive, diverse workplaces.

Required Skills:

Aseptic Manufacturing, Audits Compliance, Corrective and Preventive Action (CAPA), Documentation Review, Driving Continuous Improvement, GMP Compliance, Quality Assurance Processes, Quality Assurance Tools, Quality Standards, Root Cause Analysis (RCA)

Preferred Skills:

Manufacturing, Quality Management Systems (QMS)

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

09/13/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.