In this role, you ensure safety standards and lead the Quality Operations team, overseeing quality assurance during manufacturing while driving improvements in processes and systems.
Anforderungen
- •Completed scientific/technical university studies
- •More than 10 years of professional quality experience
- •Experienced team leader and manager
- •Experienced in problem-solving in cross-functional teams
- •Very good English skills
- •Very good German skills
- •Knowledge in lean methodologies
Deine Aufgaben
- •Ensure occupational safety and health standards.
- •Lead and develop the Quality Operations team.
- •Oversee quality assurance during manufacturing processes.
- •Provide expertise to resolve shop floor issues.
- •Evaluate deviations and complaints promptly.
- •Coordinate with QC to meet business requirements.
- •Manage the completion of Product Quality Reviews.
- •Review and approve risk assessments and change requests.
- •Approve GMP documents as per the approval matrix.
- •Support the quality risk management process.
- •Train QOps personnel on relevant SOPs.
- •Guide qualification and validation activities.
- •Assist with internal quality initiatives and audits.
- •Manage the QOps budget effectively.
- •Drive continuous process improvement using MPS and lean six sigma.
Deine Vorteile
Attractive salary
Outstanding social benefits
Exciting work environment
Varied tasks
International environment
Original Beschreibung
# Quality Operations Manager (f/m/d)
**AUT - Lower Austria - Krems An Der Donau** | **Full time** | **Hybrid**
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.
**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