QC Analytical Methods Lifecycle Lead
GSK
5 hours ago
Remote friendly (King of Prussia, PA)
United States
Operations
QC Analytical Methods Lifecycle Lead
Responsibilities:
- Provide SME support to methods lifecycle issues in collaboration with all functions involved in the analytical space.
- Provide quality oversight to ensure QC method robustness for NPI and lifecycle products.
- Support LICs, PIRCs, and difficult analytical investigations.
- Support sites during audits.
- Provide SME support for analytical transfer, methods troubleshooting, specs setting, analytical methods definition, and submission files.
- In specific cases, write or review dossier filing and HAQs.
Basic qualifications:
- Bachelor’s degree in Chemistry, Microbiology, Biological Sciences, Analytical Science, Pharmaceutical Sciences, bio or Chemical Engineering.
- 5+ years of experience in the Quality function or managing Quality-related activities in the pharmaceutical industry with quality control experience.
Preferred qualifications / skills:
- Demonstrated knowledge of the QC environment; extensive GMP knowledge; familiarity with quality and regulatory compliance requirements, including FDA/EU/ICH guidance related to analytical testing.
- Ability to apply technical knowledge to provide DMAIC support.
- Excellent written/verbal communication, presentation, and influencing skills; ability to make persuasive recommendations based on rational technical analysis.
- Strong leadership in communication and influencing with key stakeholders and at site level.
Responsibilities:
- Provide SME support to methods lifecycle issues in collaboration with all functions involved in the analytical space.
- Provide quality oversight to ensure QC method robustness for NPI and lifecycle products.
- Support LICs, PIRCs, and difficult analytical investigations.
- Support sites during audits.
- Provide SME support for analytical transfer, methods troubleshooting, specs setting, analytical methods definition, and submission files.
- In specific cases, write or review dossier filing and HAQs.
Basic qualifications:
- Bachelor’s degree in Chemistry, Microbiology, Biological Sciences, Analytical Science, Pharmaceutical Sciences, bio or Chemical Engineering.
- 5+ years of experience in the Quality function or managing Quality-related activities in the pharmaceutical industry with quality control experience.
Preferred qualifications / skills:
- Demonstrated knowledge of the QC environment; extensive GMP knowledge; familiarity with quality and regulatory compliance requirements, including FDA/EU/ICH guidance related to analytical testing.
- Ability to apply technical knowledge to provide DMAIC support.
- Excellent written/verbal communication, presentation, and influencing skills; ability to make persuasive recommendations based on rational technical analysis.
- Strong leadership in communication and influencing with key stakeholders and at site level.