Match score not available

QA Compliance Manager

extra holidays - extra parental leave

Remote:

Full Remote

Contract:

Full time

Experience:

Mid-level (2-5 years)

Work from:

Switzerland

Offer summary

Qualifications:

Qualification as a Responsible Person in Switzerland, Pharmaceutical or natural sciences degree, Minimum of 2 years pharmaceutical Quality experience, Fluent in English and German, Broad knowledge of Swiss and EU GxP requirements.

Key responsabilities:

Ensure site compliance with GMP and GDP
Lead client facing audit host team
Execute annual internal audit schedule
Communicate with regulatory authority Swissmedic
Perform training for areas of expertise

Thermo Fisher Scientific Biotech: Biology + Technology Large https://www.thermofisher.com/

10001 Employees

HQ: Waltham

See more Thermo Fisher Scientific offers

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Quality Compliance Manager, Delegate Responsible Person

Job Summary:

The position holder holds the position of the Quality Compliance Manager and is a delegate of the Responsible Person (Fachtechnisch Verantwortliche Person) for the FCS GmbH sites in Allschwil, Switzerland. In this function, they are responsible for the quality compliance, internal and client audits and act as a delegate of the Responsible Person for tasks assigned.

Key Duties and Responsibilities:

Ensure site compliance with GMP, GDP and internal procedures.
Lead the client facing audit host team and ensure that client audits are led effectively
Responsibile for the execution of the annual internal audit schedule
Perform audits as internal auditor
Delegate for Duties of the Responsible Person (Fachtechnisch verantwortliche Person) according to Swiss Medicinal Products Licensing Ordinance (Arzneimittel-Bewilligungsverordnung), permanently or in case of absence

Release decision for medicinal products (technical green light) independently from the management
Responsible for communication with the regulatory authority Swissmedic

Perform training for areas of expertise, e.g. GMP
Participate on Global Quality projects
Support PPI Projects for continuous improvement
Demonstrate and promote the company vision according to the 4i values.

Education and Qualifications:

Qualification and eligibility as a Responsible Person in Switzerland

Pharmaceutical degree, or other natural sciences degree
A minimum of 2 years pharmaceutical Quality experience, or other experience as recognized by Swissmedic

Fluent in English and German
Broad knowledge of Swiss and EU GxP requirements
Solid understanding of Excel, Word, and quality management software (e.g., Trackwise)
Excellent social skills: ability to build and maintain relationships with internal and external customers; highly Functioning team leader and team member in a dynamic business environment
Leadership skills: Proven track record to empower and encourage others, drive meaningful change, and negotiate mutually beneficial outcomes.
Strong social skills both written and verbal
Problem solving ability.

You can expect a varied job in a dynamic and international environment. A workplace culture in which integrity, intensity, involvement and innovation are lived. A well-founded induction and task-specific training are a matter of course for us. You yourself settle your future in our company - make your contribution to our joint success!

As an equal opportunity employer, Thermo Fisher Scientific is committed to supporting underrepresented groups and does not discriminate on the basis of ethnicity, color, religion, gender, sexual orientation, gender identity, national origin, disability or legally protected status.