Quality Operations Manager (f/m/d)

Job Description

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high-quality, reliable supply to customers and patients on time, every time.

For our site in Krems, we are currently looking for a:

Quality Operations Manager (f/m/d)

Mission

Lead Quality Operations.

Establish and maintain the Quality Operations unit according to Austrian Drug Law, European GMP and USDA requirements at our Animal Health Vaccine manufacturing site Krems.

Main tasks

• Responsible for occupational safety, health and environment within Quality Operations department

• Lead the Quality Operations team, Coach and Develop Employees including QP

• End responsible for the Quality Assurance related activities during manufacturing and control of drug products, from starting materials inspection, intermediates to finished goods shipping

• Provide expertise knowledge to operations to resolve shop floor issues and/or implement corrections.

• Ensure deviations and complaints are evaluated by quality operations in a timely manner, escalate when needed, and support the investigation process.

• Work with QC, Supply Chain and Operations to meet business requirement (such as release on time).

• Oversee the timely coordination and completion of the Product Quality Review (PQR/APR)

• Review and approve risk assessments, change requests, deviations, investigations, and associated CAPAs

• Review and approve GMP documents according to approval matrix (SOPs, protocols, reports…)

• Support the quality risk management process

• Ensure QOps personnel is trained in the appropriate SOPs

• Support and provide guidance in qualification and validation activities.

• Assist internal Quality Initiatives and internal audits as required. Assist as needed with Health Authorities inspections.

• Responsible for QOps budget

• Provide continuous improvement of quality processes and systems by using Production System (MPS), lean six sigma.

Education and Skills

• Completed scientific/technical university studies (biotechnology, chemistry, microbiology or comparable disciplines)

• More than 10 years of professional quality experience in the pharmaceutical and/or medical technology industry in various roles

• Experienced team leader and manager,

• Experienced in moderation of problem-solving working in a cross functional team

• Very good English and German skills

• Knowledge in lean (Six Sigma or similar)

We offer an attractive salary, outstanding social benefits and an exciting work environment with varied tasks in an international environment. The minimum annual salary for this position is EUR 79.600 and varies according to the qualifications and experience of the successful candidate. We are looking forward to receiving your application.

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:

International

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Required Skills:

Biological Sciences, Biological Sciences, Biomedical Technologies, Biotechnology, Business Management, Business Operations, Business Planning and Control System (BPCS), Change Management, Communication, Computer System Validation (CSV), Decision Making, Driving Continuous Improvement, Escalation Management, GMP Compliance, GMP Laboratory, Immunochemistry, IS Audit, Lean Six Sigma (LSS), Management Process, Manufacturing Processes, Microbiology, Molecular Microbiology, People Leadership, Performance Qualification (PQ), Product Inspections {+ 19 more}

Preferred Skills:

Job Posting End Date:

06/16/2025

*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.