QA Compliance Manager

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $50 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 sophisticated analytical challenges, growing efficiency in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them.

Our distributed team of more than 100,000 colleagues delivers an outstanding 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.

Fisher Clinical Services GmbH is part of Thermo Fisher Scientific Corporation, an outstanding company serving the scientific community and healthcare industry. We are leaders in providing clinical supply chain management services and clinical supplies distributed to patients worldwide. For more information about our site in Allschwil please visit: www.fisherclinicalservices.com.

For our location in Allschwil/Basel we are looking for an office based

QA Compliance Manager

This is an outstanding opportunity to join Thermo Fisher Scientific Inc., an extraordinary leader in serving science, as a QA Compliance Manager in our Manufacturing team. You will help resolve and efficiently implement quality compliance strategies, ensuring detailed operations at our Allschwil/Basel location. Your high-reaching spirit and shown expertise will supply significantly to our mission of making the world healthier, cleaner, and safer.

Your Responsibilities:

• Ensure site compliance with GMP, GDP, and internal procedures.
• Lead the client-facing audit host team and ensure that client audits are conducted effectively.
• Responsible for completing the annual internal audit schedule.
• Perform audits as an internal auditor.
• You will represent the Responsible Person (Fachtechnisch verantwortliche Person) as needed, following Swiss Medicinal Products Licensing Ordinance (Arzneimittel-Bewilligungsverordnung).
• Independently make release decisions for medicinal products (technical green light) separate from management.
• Maintain communication with the regulatory authority, Swissmedic.
• Conduct training sessions in areas of expertise, such as GMP.
• Participate in Global Quality projects.
• Support PPI Projects for continuous improvement.
• Demonstrate and promote the company vision according to the 4i values.

Your Qualifications:

• Qualification and eligibility as a Responsible Person in Switzerland.
• Pharmaceutical degree or equivalent experience in a natural sciences field.
• Minimum of 2 years of pharmaceutical Quality experience, or other experience recognized by Swissmedic.
• Proficient in English and German (French and Italian is an advantage).
• Broad knowledge of Swiss and EU GxP requirements.
• Solid understanding of Excel, Word, and quality management software (e.g., Trackwise).
• Excellent communication skills: ability to build and maintain relationships with internal and external customers; highly functioning team leader and team member in a dynamic business environment.
• Validated leadership skills: ability to empower and encourage others, drive meaningful change, and negotiate mutually useful outcomes.
• Strong communication skills, both written and verbal.
• Problem-solving ability.

We offer competitive remuneration, an annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific provides employment within an innovative, forward-thinking organization, offering outstanding career and development prospects. Join us and thrive in a company culture that values integrity, intensity, involvement, and innovation!