Quality Release Lead (m/f/d)

Zug Interim

Added 12/04/2024

  • Internationally operating, pharmaceutical company
  • Temporary assignment until the end of the year

About Our Client

Our client, an internationally renowned Pharmaceutical company is recruiting. On its behalf we are now looking for a Quality Release Lead (m/f/d) available immediately for Zug area, to join an international team until the end of the year.

Depending on the selected candidate's performance and motivation, the possibility of an extension or a permanent take over.

Job Description

The selected candidate is responsible for ensuring that each individual batch has been manufactured in compliance with laws in force in the country of destination, in accordance with the requirements of the marketing authorization and with good manufacturing practice, by carrying out the following task areas:

  • Reviews and verifies batch release documentation according to local procedures and product specific checklist.
  • Prepares and approves the certificates of conformance and market-specific release documentation.
  • Checks quality-relevant status changes of the inventory in the client's systems
  • Influences the strategy of the manufacturing of their products at the CMOs and to sustain without disruption of the supply chain.
  • Contributes to launches, commercialization, technology transfer or improvements projects through release process adjustments.
  • Collects and performs KPIs analyses including feedback from other departments (for example planning).
  • Manages stakeholder and delegates for the release activities through SME assessment and decision making.
  • Identifies and drives improvements/updates of the GMP documentation related to release activities and CMO oversight from release perspective.
  • Identifies any compliance gap in the client's processes and identifies appropriate stakeholder to fix the issue.
  • Supports local quality system (change control, deviations, CAPAs, …) as required.
  • Ensures adherence to serialization and data integrity requirements.

The Successful Applicant

In order to be considered for the role, the selected candidate must have:

  • Successfully completed bachelor's and/or master's degree in a scientific field (Pharmacy, Chemistry, Biology, Biochemistry etc)
  • Minimum 6 years' working experience within a similar role in the pharmaceutical or biotechnological industry.
  • Experience in the pharmaceutical industry (small molecules and/or biotechnology and/or aseptic filling)
  • Solid 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 cross-functional project teams.

What's on Offer

The selected candidate will be part of a dynamic team and actively contribute to shape, develop, and drive the department for success!

Contact
Christina Beer
Quote job ref
JN-042024-6394376

Job summary

Job Function
Engineering & Manufacturing
Specialisation
Quality
Industry
Healthcare / Pharmaceutical
Location
Zug
Contract Type
Interim
Consultant name
Christina Beer
Job Reference
JN-042024-6394376

PageGroup is an equal opportunity employer committed to workforce diversity, both as an employer as well as a recruitment service provider. Each recruitment decision we make for people we hire and people we place into new roles is based solely on the candidates’ knowledge, experience and skills.