Work Schedule
Standard (Mon-Fri)Environmental Conditions
Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, OfficeJob Description
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. And with over $1 billion invested annually in R&D, we empower our teams to put science into meaningful action and give our R&D colleagues the autonomy, resources and tools they need to take science a step beyond.
Position PurposeThis is a remarkable opportunity to join Thermo Fisher Scientific Inc. as a Supervisor QA Systems & Compliance. In this role, you will oversee and supervise compliance activities within our Lengnau site, ensuring our processes meet the highest standards of quality and reliability. You will interact with varying levels of staff within the organization, as well as customers and auditors, to strictly determine and successfully implement outstanding compliance processes.
Key Responsibilities- Coordinate and supervise compliance activities within the Lengnau site.
- Make critical decisions regarding process compliance to impact product quality.
- Coordinate or lead QA activities including quality agreements, metrics, self-inspection, inspection readiness programs, supplier qualification, auditing, record review, final product functions, complaints, document management, risk management, and oversight of quality systems and investigations within QA.
- Manage the lifecycle of associated concepts/programs, policies, and procedures.
- A Master's degree in a life science field is required. Equivalent work experience and knowledge can substitute.
- More than 10 years of proven experience in the pharmaceutical industry.
- Excellent knowledge of Operations and Quality Assurance for biological pharmaceuticals (cGMP) with over 5 years of experience.
- In-depth knowledge of Quality practices, cGMP regulations, and international health authority guidelines (especially Swissmedic and US FDA).
- On-call services (picket light / 2nd level remote), based on department organization.
Top Skills
What We Do
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 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.
Why Work With Us
You will join a company which every colleague has the opportunity to create possibilities, for oneself, for our customers and patients. There is no more exciting place to be than at the forefront of solving problems which help improve lives around the world. As a company, we are committed to supporting your career aspirations and your journey.
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