Manager (M/F/d) Quality Management / Qualification

Vor 2 Tagen

Lengnau, Schweiz Thermo Fisher Scientific Vollzeit

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

**Location/Division Specific Information**
The state-of-the-art multi-purpose manufacturing facility is designed for large-scale production of biologics and has high expansion potential. After completion of construction activities, our site in Lengnau will offer highly flexible biomanufacturing technologies, from development to large-scale production including stainless steel equipment to meet our customer needs.

**Discover Impactful Work**:
In this role, you will lead key topics affecting the Commissioning and Qualification (C&Q) in alignment with our C&Q Engineers and cross functional C&Q teams. You will be the single point of contact at our Site in Lengnau for all Quality Compliance related matters affecting C&Q. Your Quality decision will be key for the success of our C&Q phase.
We are seeking a strong leader who is passionate about an efficient and risk based, science-based C&Q approach and excited to join our team to drive success across the Site. This is locally a highly visible role that interfaces with all management levels within a very challenging and demanding business environment. There is significant opportunity for professional growth and development in this position.

**Key responsibilities**:

- The role will oversee both systems and execution of qualification, working closely with the Engineering Services, Commissioning and Qualification teams and Quality Control to deliver qualified facilities, utilities, equipment and analytical instruments, ready for commercial production.
- Ensures systems and processes for commissioning & qualification, calibration, maintenance and for maintaining the qualified status of equipment are in place and followed. Ensures as QA representative that systems and processes are appropriate and meeting regulatory expectations.
- Acts as Quality approver for all documents related to qualification and validation including lifecycle documents to assure the compliance with internal and external regulations and standards.
- The role oversees QA qualification technicians within the Qualification/Validation group and deputize the Senior Manager QM Qualification & Validation - Lengnau in case of need.
- The role is responsible for regulatory compliance associated to Qualification and Validation and is expected to contribute to related areas of regulatory submissions and support audits and inspections in the field of expertise

**Keys to Success**:
**Education**
- Degree (Bachelor, Masters or higher) in Engineering or Life Sciences (Biology, Chemistry, etc.), Dipl. Ing. or M.Sc. or B.Sc. or equivalent.
- Able to lead staff by example, providing technical and personal support. Able to work collaboratively with others to ensure successful outcomes.

**Experience**
- Strong operational experience preferably gained within the construction & qualification environment ideally on a Life Sciences / Pharma / Biotech Upstream/Downstream/Fill Finish manufacturing facility.
- Several years (at least 7 years) of successful commissioning and/or qualification experience on mid-sized and major projects with high complexity in the chemical, biotech-or pharmaceutical industry.
- Proven experience and knowledge in chemical, biotech or pharmaceutical process, automation and engineering.
- Proven experience in cGMP, GLP & cGxP and qualification/ validation and experience in presenting C&Q topics to regulators (Swissmedic, FDA, others).

**Knowledge, Skills, Abilities**
- Excellent time management skills, with the flexibility to manage changing priorities and multiple tasks.
- Excellent verbal and written communication skills with the ability to present to a range of audiences at all levels within the organization.
- Languages: English fluent in writing and spoken, German is an add-on

**What we offer**
- Employment with an innovative organization
- Outstanding career and development prospects
- Company pension scheme and other fringe benefits
- Exciting company culture which stands for integrity, intensity, involvement and innovation

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identit

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