The role serves as the single point of accountability for all Drug Substance and Drug Product fleet equipment standards across global sites
Job Summary
The role serves as the single point of accountability for all Drug Substance and Drug Product fleet equipment standards across global sites.
Candidates must possess a Master's degree in Engineering or Life Sciences with at least 10 years of experience in multi-site pharmaceutical operations.
The position requires leading impact analysis for changes to ensure consistent implementation while maintaining strict regulatory compliance.
Matching Summary
The role serves as the single point of accountability for all Drug Substance and Drug Product fleet equipment standards across global sites.
Salary
Not specified; Not specified; Not specified
Skills & Requirements
Must-have
Master's degree in Engineering or Life Sciences
10+ years pharmaceutical industry experience
Deep expertise in GMP and Quality Systems
Experience with multi-site operations standardization
Knowledge of ICH Q10 and ICH Q12 regulations
Nice-to-have
PhD in related technical field
Strong leadership and communication skills
Champion of standardization culture
Ability to influence diverse functional groups
Key Requirements
Minimum 10 years experience in pharma/biotech
Master's degree required (PhD plus)
Expertise in lifecycle management of complex equipment
Proven track record in change management processes