Supervisor QA Systems & Compliance

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office

Job 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 Purpose

This 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.

Education

• A Master's degree in a life science field is required. Equivalent work experience and knowledge can substitute.

Experience & Proficiencies

• 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).

Additional Requirements

• On-call services (picket light / 2nd level remote), based on department organization.