Quality Control Manager

Allschwil - Switzerland

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Analytical Development - Quality Control Manager, Allschwil

The position will be a temporary contract with the end client. The duration is yet to be determined.

Job Responsibilities:

The Manager working in AD/QC will have the following responsibilities and tasks:

Responsible for Analytical Development and Quality control for assigned CMC program in late-stage development (typically phase 3 and commercial).
Management of external analytical testing labs ensuring in time, in full availability of clinical trial material complying with product requirements and cGMP .
Point of contact and supervision for analytical 3rd parties labs, e.g., CMOs and CROs, for defined analytical tasks.
Development, optimization and implementation of analytical methods with or at external testing labs, e.g., for purity-, stability-, excipients-, content-, and potentially genotoxic impurity determinations
Representation of AD/QC in technical project team and CMC team meetings.
Review, interpretation and documentation of analytical data including results from method development, release, retest, validation, stability, and transfer.
Write-up and review of analytical protocols and reports and establish specifications.
Support a 5 years horizon budget for the assigned program and support line manager in monitoring program spending including quarterly forecast review for reporting to finance and management.
Establishment of source documents for IND, IMPD, and NDA/MA submissions
Lead external laboratory work to support product or process troubleshooting, special investigations, deviations, change requests, CAPA, product complaints and other analytical tasks independently.

Candidate Requirements:

College, or university-degree or equivalent education in the field of chemistry, biochemistry, pharmacy, biology or chemical engineering with 12 years BS, 9 years MS or 2 years PhD experience in the pharmaceutical industry.
In addition to knowledge of the GMP/regulatory requirements, a strong background in analytical chemistry is required.
Personality and disposition to manage professionals effectively in a matrix system.
Willingness to limited travel.
Proficient in English.
Life-long learning mindset and a strong sense of accountability. Should actively seek for technical and scientific solutions to improve quality and productivity.
Strong skills in timeline development and management.
Broad knowledge in analytical chemistry.

If you are interested, please send a CV in English at

It is essential that applicants hold entitlement to work in Switzerland.

Analytical Development - Quality Control Manager, Allschwil The position will be a temporary contract with the end client. The duration is yet to be determined. Job Responsibilities: The Manager working in AD/QC will have the following responsibilities and tasks:Responsible for Analytical Developmen...

Responsible for Analytical Development and Quality control for assigned CMC program in late-stage development (typically phase 3 and commercial).
Management of external analytical testing labs ensuring in time, in full availability of clinical trial material complying with product requirements and cGMP .
Point of contact and supervision for analytical 3rd parties labs, e.g., CMOs and CROs, for defined analytical tasks.
Development, optimization and implementation of analytical methods with or at external testing labs, e.g., for purity-, stability-, excipients-, content-, and potentially genotoxic impurity determinations
Representation of AD/QC in technical project team and CMC team meetings.
Review, interpretation and documentation of analytical data including results from method development, release, retest, validation, stability, and transfer.
Write-up and review of analytical protocols and reports and establish specifications.
Support a 5 years horizon budget for the assigned program and support line manager in monitoring program spending including quarterly forecast review for reporting to finance and management.
Establishment of source documents for IND, IMPD, and NDA/MA submissions
Lead external laboratory work to support product or process troubleshooting, special investigations, deviations, change requests, CAPA, product complaints and other analytical tasks independently.

Candidate Requirements:

College, or university-degree or equivalent education in the field of chemistry, biochemistry, pharmacy, biology or chemical engineering with 12 years BS, 9 years MS or 2 years PhD experience in the pharmaceutical industry.
In addition to knowledge of the GMP/regulatory requirements, a strong background in analytical chemistry is required.
Personality and disposition to manage professionals effectively in a matrix system.
Willingness to limited travel.
Proficient in English.
Life-long learning mindset and a strong sense of accountability. Should actively seek for technical and scientific solutions to improve quality and productivity.
Strong skills in timeline development and management.
Broad knowledge in analytical chemistry.

If you are interested, please send a CV in English at

It is essential that applicants hold entitlement to work in Switzerland.