QA Manager

Hobson Prior are looking for a QA Manager to join a fantastic organisation on a contract basis located in Zurich. Our client is focused on finding transformative remedies for people globally.

Please note that to be considered for this role you must have the right to work in this location.

**Key Responsibilities**:

- For the position of QA Manager, you will be accountable for generating and augmenting co-operative and trusting relationships with internal and external laboratories and internal SMEs and institute effective communication.
- Arrange and direct cross functional team meetings with internal and external laboratories and SMEs.
- Initiate and support systematic technique life cycle management (LCM) approach.
- You will be responsible for running multisite assay transfers via supplying assay transfer tactic and project management with internal and external laboratories.
- Assist as SME for diagnostic approaches involving biological, molecular biological and microbiological approaches established in the commercial release testing laboratories.
- Procure ownership of analytical issues and drive conclusion rapidly, appropriately, and concretely for commercial products.
- As the QA Manager, you will serve as the in-house analytical / technical professional for troubleshooting and investigating laboratory matters.
- Instigate statistical analysis for data clarification and execute chemometric principles to resolve complicated analytical topics and submissions.
- You will author/analyse/agree method authentication/transfer protocols/reports and correlated SOP.
- Coordinate and lead re-manufacturing of critical reagents for analytical methods.
- Author/review/approve quality control plans / qualification protocols/reports and re-test protocols/reports of critical reagents for analytical methods.
- This role entails you to author/evaluate/accept regulatory related documents.
- Hold accountability for technical evaluation of approaches and fluctuations to procedures for compliance to GMP necessities, global Pharmacopeia's, business standards etc.
- Support colleagues in quality supervision to cell bank and virus seed engineering, formation and upkeep of cell bank and virus seed specification.
- Any other assigned duties.

**Key Skills**:

- Strong verbal & written communication skills (including presentation skills). Can effectively articulate complex technical issues to non-technical audience.
- Capability to work well in teams.

**Requirements**:

- Educated to a degree level in microbiology, pharmaceutical science, biotechnology, chemistry or a similar field with at least 3 years of experience within a QC laboratory or QA organisation (with oversight of QC activities).
- You will be proficient in the English language is required for this role.
- Skilled in the German language is beneficial, but not essential for the role.
- An exhaustive comprehension of pharmaceutical QMS systems and respective measures and QC laboratory processes is needed and knowledge in an outsourced manufacturing and testing setting is preferable, but not essential to the role.
- Prior experience in vaccines and biologics manufacturing and testing and related guideline and knowledge of pharmaceutical cGMPs (US and EU) and CMC regulatory requirements is preferred but not essential to the role.
- Solid technical expertise in microbiology and microbial approaches and composition, and statistical procedures for data analyses.
- Prior experience in heading and distributing effective Technology Transfer activities across the CMO and internal network.
- Having obtained Six Sigma Lean Laboratory, Greenbelt or Blackbelt certification is preferable but not essential.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.