Job Description
Our Quality Assurance 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 in-house production sites and cooperation with external manufacturers and suppliers, we have created a closely interconnected global production network that is committed to reliably and punctually supplying customers and patients worldwide with products that meet high quality standards in every individual case.
We are looking for a Specialist Quality Systems and Compliance (m/f/d) at our Unterschleißheim site as soon as possible. The position is full-time.
Responsibilities / Tasks:
- Ensuring the timely qualification and requalification of GMP-relevant suppliers, service providers and contract manufacturers used at the site
- Creating and updating Technical Quality Agreements (TQAs)
- Creating and maintaining annual inspection programs to be carried out at suppliers, and participating in the corresponding audits as needed
- Evaluating change notifications / change requests submitted by suppliers and initiating necessary follow-up measures as needed
- Tracking and evaluating corrective actions identified in the context of supplier qualification and change requests
- Serving as the point of contact for quality-related matters arising in connection with suppliers, service providers and contract manufacturers
- Taking over responsibility for a sub-system
- Initiating, carrying out and monitoring Continuous Improvement activities
- Identifying and prioritizing improvement potential in processes and workflows
- Recording quality-related key performance indicators and continuously optimizing the system to maintain GMP-relevant requirements
- Creating and further developing quality-related SOPs
- Supporting regulatory authority inspections
- Supporting other projects in the area of quality systems
Requirements / Competencies:
- Successfully completed degree in a natural science field, e.g. Pharmacy, Food Technology, Chemistry, or a comparable qualification
- 2 years of experience in the pharmaceutical industry, preferably in the area of quality assurance
- Independent, solution-oriented and proactive way of working
- Very good German and English skills, spoken and written
- Very good knowledge of Microsoft Office (Outlook, Word, Excel, PowerPoint)
- Very good communication skills
- High level of teamwork ability
The stated goal of our Production & Supply business area is to act as the world's most reliable manufacturer and supplier of biopharmaceuticals. Together with our external contractors, suppliers and partners, our production sites form a closely interconnected global production network that is committed to reliably and punctually supplying customers and patients with high-quality products in every individual case.
We are proud to be a company built on the values of our diverse, talented and committed employees. The fastest way to advance innovative developments is to bring different ideas together in an inclusive environment. We encourage our colleagues to discuss their ideas objectively and to tackle problems together. We see ourselves as an equal opportunity employer and are committed to promoting inclusive and diverse workplaces.
Additional location(s) Compensation Information:
Required Skills:
Audit Processes, Corrective Action Management, Good Manufacturing Practices (GMP), Quality Assurance Systems, Quality Improvement Programs, Quality Standards, Subcontract Management, Supplier Identification, Supply Chain Improvements, Vendor Communications
Preferred Skills:
English Language, German Language
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:
No Travel Required
Flexible Work Arrangements:
Hybrid
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
11/20/2026
*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.