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Location

Friesoythe | Germany

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Job description

Job Description

The 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 sites form a closely interwoven global production network that is committed to supplying customers and patients with high-quality products reliably and on time, every time .

To join our Quality Operations Teams at our pharmaceutical manufacturing site in Friesoythe, Germany we are looking for a permanent full-time:

Manager Quality Assurance Operations (m/w/d)

Your main responsibilities will be to support our newly build production area (liquid- and powder manufacturing and filling and packaging).

Your Main Pesponsibilities:

• Responsible for occupational safety, health and environment of the employees of the subteam of Quality Operations responsible for the new manufacturing, filling and packaging area
• Leading the Quality Operations subteam, Coach and Develop Employees
• End to end responsible for the Quality Assurance related activities of the new manufacturing area during manufacturing, control of drug products and packaging operations, from starting materials inspection to finished goods shipping, including intermediates
• Provide expertise knowledge to operations to resolve shop floor issues and/or implement corrections
• Ensure deviations and complaints are evaluated by the team in a timely manner, escalate when needed, and support the investigation process
• Support the quality risk management process
• Oversee the timely coordination and completion of the Product Quality Review (PQR/APR)
• Review and approve risk assessments, complaints, change requests, deviations, investigations, and associated CAPAs
• Review and approve GMP documents according to approval matrix (SOPs, protocols, reports…)
• Ensure personnel is trained in the appropriate SOPs
• Assist internal QualityiInitiatives and internal audits as required. Assist as needed with Health Authorities inspections
• Work with Quality Control, Supply Chain and Operations to meet business requirement for the new manufacturing area

Your Profile:

• Studied applied science or equivalent education with at least 5 years of experience preferably in the pharmaceutical industry
• Experience in leading a team and moderation of problem solving and leading a cross functional team
• Strong GMP knowledge
• Experience in Quality Risk Management
• Experience in qualification and validation (utilities, equipment, processes…)
• Very good English and German skills
• Knowledge in lean Six Sigma and problem solving

Our Benefits:

• Flex Time (37.5 hours/week)
• Attractive compensation package (13 monthly salaries plus target bonus)
• Company pension plan
• Vacation allowance (1,200€ annually)
• 30 days annual leave
• Employee benefits
• Company bike / bicycle leasing
• Additional payment for Hansefit (Fitness Membership)

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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:

Domestic

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Flex Time

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Requisition ID: R271732

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Job tags

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Salary