You oversee compliance and quality assurance activities, making key decisions to ensure product quality while effectively managing various QA processes and systems.
Anforderungen
- •Master's degree in life science required
- •More than 10 years experience in pharmaceuticals
- •Excellent knowledge of cGMP with 5 years experience
- •In-depth knowledge of cGMP regulations
- •On-call services based on department organization
Deine Aufgaben
- •Coordinate and supervise compliance activities.
- •Make critical decisions on process compliance.
- •Lead QA activities including quality agreements.
- •Manage metrics and self-inspection programs.
- •Ensure inspection readiness and supplier qualification.
- •Conduct auditing and record reviews.
- •Oversee final product functions and complaints.
- •Manage document and risk management systems.
- •Oversee quality systems and investigations.
- •Manage the lifecycle of policies and procedures.
Original Beschreibung
# Supervisor QA Systems & Compliance
**Lengnau, Switzerland** | **Full time** | **Fully Onsite**
**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**
## 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.