Sr. Quality Release Lead - Zug, Schweiz - Swisslinx

Swisslinx

Geprüftes Unternehmen

Zug, Schweiz

vor 1 Woche

Geschrieben von:

Lena Schneider

beBee Recruiter

Beschreibung

On behalf of our client, a leading global pharmaceutical company, we are now looking for a Senior Quality Release Lead.

Start Date:
As soon as possible

Location:
Zug

Workload: 100%

Duration:
Until December 31st, 2024 (extension possible)

Your mission:

Review and verification of batch release documentation according to local procedures and product specific checklist.
Preparation and approval of the certificates of conformance and marketspecific release documentation.
Qualityrelevant Status changes of the inventory in the Company's systems.
Influence the strategy of the manufacturing of our products at the CMOs and to sustain without disruption of the supply chain.
Able to identify and drive improvements/updates of the GMP documentation related to Release activities and CMO oversight from release perspective.
Identify and communicate timely to the management any supply risk or risk of batch rejection.
Decisions with patient, global or regulatory impact must be taken in collaboration with upper management.

Your background:

Minimum Bachelor's degree, Master degree preferred, in a scientific topic (Pharmacy, Chemistry, Biology, Biochemistry etc.).
A minimum of 6 years of experience in similar position in pharmaceutical or biotechnology industries.
Experience in the pharmaceutical industry (small molecules and/or biotechnology and/or aseptic filling). Sound knowledge of cGMP requirements, EU/FDA regulations and

compliance. Experience in clinical products manufacturing and/or regulatory is an asset. Knowledge of medical device regulations and manufacturing is a plus.

Ability to develop effective working relationships with internal/external sites and crossfunctional project teams.
Negotiation skills.
Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment.

What's Offered: