Quality Manager
Join a Leading Biopharma Company as a Quality Manager!
On behalf of our client, a multinational Pharmaceutical company, Swisslinx is seeking a Quality Manager.
Contract Type: Contract
Start Date: ASAP
Location: Zurich
Workload: 100%
Duration: 1.5 year (extension possible)
Your Mission:
* Drive and support analytical method life cycle management (LCM) for in-process, release, and stability testing of commercial products.
* Lead multisite assay transfers by developing transfer strategies and managing projects with both internal and external laboratories.
* Serve as a Subject Matter Expert (SME) for analytical methods, including biological, molecular, and microbiological techniques used in commercial release testing.
* Take ownership of analytical issues, ensuring swift and effective resolution for commercial products.
* Act as an in-house technical expert for troubleshooting and investigating laboratory issues, utilizing statistical analysis and chemometric principles.
* Represent Quality Control in technical product teams, collaborating closely with internal analytical and process experts.
* Author, review, and approve method validation/transfer protocols, reports, SOPs, and regulatory documents related to analytical methods.
* Lead the coordination and re-manufacturing of critical reagents for analytical methods, ensuring compliance with GMP, global Pharmacopeias, and industry standards.
* Build and maintain collaborative relationships with internal and external laboratories and SMEs, fostering effective communication and teamwork.
* Organize and lead cross-functional team meetings to address analytical challenges and drive continuous improvement.
Your Background:
* Degree in microbiology, pharmaceutical science, biotechnology, chemistry, or a related field, with a minimum of 3 years of experience in a QC laboratory or QA organization
overseeing QC activities.
* Thorough understanding of pharmaceutical Quality Management Systems (QMS), guidelines, and QC laboratory processes.
* Preferred experience in an outsourced manufacturing and testing environment, particularly in vaccines and biologics manufacturing.
* Strong technical expertise in microbiological methods and instrumentation, as well as statistical methods for data analysis.
* Proven track record of successfully leading Technology Transfer activities across Contract Manufacturing Organizations (CMOs) and internal networks.
* Excellent verbal and written communication skills, with the ability to convey complex technical issues to non-technical audiences effectively.
* Ability to work collaboratively within cross-functional teams.
* Fluency in English is required; German is a plus.
* Six Sigma Lean Laboratory, Greenbelt, or Blackbelt Certification is preferred.
What's on Offer?
* A chance to showcase your expertise in a leading global biopharma company.
* Join a dynamic team and be a part of a positive, collaborative company culture.
If this sounds like the right opportunity for you, don't hesitate to apply here or reach out directly to Veronika von Mentzer, Recruiter: Write an email.
On behalf of our client, a multinational Pharmaceutical company, Swisslinx is seeking a Quality Manager.
Contract Type: Contract
Start Date: ASAP
Location: Zurich
Workload: 100%
Duration: 1.5 year (extension possible)
Your Mission:
* Drive and support analytical method life cycle management (LCM) for in-process, release, and stability testing of commercial products.
* Lead multisite assay transfers by developing transfer strategies and managing projects with both internal and external laboratories.
* Serve as a Subject Matter Expert (SME) for analytical methods, including biological, molecular, and microbiological techniques used in commercial release testing.
* Take ownership of analytical issues, ensuring swift and effective resolution for commercial products.
* Act as an in-house technical expert for troubleshooting and investigating laboratory issues, utilizing statistical analysis and chemometric principles.
* Represent Quality Control in technical product teams, collaborating closely with internal analytical and process experts.
* Author, review, and approve method validation/transfer protocols, reports, SOPs, and regulatory documents related to analytical methods.
* Lead the coordination and re-manufacturing of critical reagents for analytical methods, ensuring compliance with GMP, global Pharmacopeias, and industry standards.
* Build and maintain collaborative relationships with internal and external laboratories and SMEs, fostering effective communication and teamwork.
* Organize and lead cross-functional team meetings to address analytical challenges and drive continuous improvement.
Your Background:
* Degree in microbiology, pharmaceutical science, biotechnology, chemistry, or a related field, with a minimum of 3 years of experience in a QC laboratory or QA organization
overseeing QC activities.
* Thorough understanding of pharmaceutical Quality Management Systems (QMS), guidelines, and QC laboratory processes.
* Preferred experience in an outsourced manufacturing and testing environment, particularly in vaccines and biologics manufacturing.
* Strong technical expertise in microbiological methods and instrumentation, as well as statistical methods for data analysis.
* Proven track record of successfully leading Technology Transfer activities across Contract Manufacturing Organizations (CMOs) and internal networks.
* Excellent verbal and written communication skills, with the ability to convey complex technical issues to non-technical audiences effectively.
* Ability to work collaboratively within cross-functional teams.
* Fluency in English is required; German is a plus.
* Six Sigma Lean Laboratory, Greenbelt, or Blackbelt Certification is preferred.
What's on Offer?
* A chance to showcase your expertise in a leading global biopharma company.
* Join a dynamic team and be a part of a positive, collaborative company culture.
If this sounds like the right opportunity for you, don't hesitate to apply here or reach out directly to Veronika von Mentzer, Recruiter: Write an email.
By applying for this position, I consent to the Swisslinx Group of companies:
- storing my personal information (including name, contact details, Identification and CV information etc.) on their internal or external servers for the purpose of informing me of potential employment opportunities
- using my personal information or
- supplying it to third parties upon express consent for the purpose of informing me of potential job opportunities
- transferring where applicable my personal information to a country outside the EEA/EFTA
I also hereby agree to the Swisslinx privacy policy (http://www.swisslinx.com/en/legal/privacy-policy) and Terms of Use (http://www.swisslinx.com/en/legal/disclaimer)
Website
https://www.swisslinx.com/job/16217en
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