Jobid=cc8cc53e5df1 (0.1016)
Overview
PM Group are seeking an experienced Quality Lead to oversee all site quality matters for a major pharmaceutical construction project in the Netherlands. This critical role requires a seasoned professional to establish and maintain the highest quality standards throughout the construction and commissioning phases of a state-of-the-art pharmaceutical manufacturing facility.
Responsibilities
The successful candidate will be responsible for implementing comprehensive quality management systems, ensuring GMP compliance, and managing all quality-related activities from construction through to facility handover and validation.
Establish and maintain project quality management systems aligned with pharmaceutical industry standards
Ensure all construction activities comply with Good Manufacturing Practice requirements and regulatory standards
Direct daily quality activities across all construction disciplines and contractors
Oversee quality documentation, IQ/OQ protocols, and validation master plans
Coordinate internal and external quality audits, regulatory inspections, and client assessments
Lead investigation and resolution of quality issues and deviations
Monitor subcontractor quality performance and compliance with project specifications
Deliver quality training programs for project teams and contractors
Qualifications
Degree in Engineering, Science, Quality Management, or related discipline
Minimum 8+ years in quality management roles on major construction / engineering projects
Proven experience in pharma facility construction quality management
Deep understanding of GMP, and Belgian/EU pharmaceutical regulations
Extensive experience with ISO 9001, quality management systems, and validation processes
Fluent English essential; Dutch/French advantageous
Qualified internal auditor with experience managing regulatory inspections
Professional quality qualification advantageous
Experience with cleanroom construction and controlled environment validation advantageous
Understanding of pharmaceutical engineering standards
D&I
Inclusion and Diversity are core to our culture and values. Wherever we work, we commit to a culture of mutual respect and belonging by building a truly inclusive workplace rich in diverse people, talents and ideas. Valuing the contributions of all our people and respecting individual differences will sustain our growth into the future.
PM Group is committed to ensuring our hiring process is fair and accessible to all and will provide candidates with disabilities with reasonable accommodations required to participate in the recruitment process. If you require any assistance in this regard, please let us know.
For more company information visit our company website > Meet Our Team – careers | PM Group
#LI-EB1
The successful candidate will be responsible for implementing comprehensive quality management systems, ensuring GMP compliance, and managing all quality-related activities from construction through to facility handover and validation.
Establish and maintain project quality management systems aligned with pharmaceutical industry standards
Ensure all construction activities comply with Good Manufacturing Practice requirements and regulatory standards
Direct daily quality activities across all construction disciplines and contractors
Oversee quality documentation, IQ/OQ protocols, and validation master plans
Coordinate internal and external quality audits, regulatory inspections, and client assessments
Lead investigation and resolution of quality issues and deviations
Monitor subcontractor quality performance and compliance with project specifications
Deliver quality training programs for project teams and contractors
Degree in Engineering, Science, Quality Management, or related discipline
Minimum 8+ years in quality management roles on major construction / engineering projects
Proven experience in pharma facility construction quality management
Deep understanding of GMP, and Belgian/EU pharmaceutical regulations
Extensive experience with ISO 9001, quality management systems, and validation processes
Fluent English essential; Dutch/French advantageous
Qualified internal auditor with experience managing regulatory inspections
Professional quality qualification advantageous
Experience with cleanroom construction and controlled environment validation advantageous
Understanding of pharmaceutical engineering standards
D&I
Inclusion and Diversity are core to our culture and values. Wherever we work, we commit to a culture of mutual respect and belonging by building a truly inclusive workplace rich in diverse people, talents and ideas. Valuing the contributions of all our people and respecting individual differences will sustain our growth into the future.
PM Group is committed to ensuring our hiring process is fair and accessible to all and will provide candidates with disabilities with reasonable accommodations required to participate in the recruitment process. If you require any assistance in this regard, please let us know.
For more company information visit our company website > Meet Our Team – careers | PM Group
#LI-EB1
Lees hier meer
Deel deze vacature: