Overview
PM Group are seeking an experienced Quality Lead (Turnover) to oversee all site quality matters, with primary focus on Turnover activities for a major pharmaceutical construction project in Geel, Belgium. 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.
1. Managing Project Completions for multiple systems
2. Approval of Vendor Turnover Packages (VTOPs)
3. Approval of Trade Turnover Packages (TTOPs)
4. Coordination of Trade Walkdowns
5. Punchlist Management and closeout
6. Managing Engineering Document Control
7. Transfer of VTOPs & TTOPs to Operations
8. Receipt, review and acceptance of As Built Drawings
9. Management of Non GMP Change Controls
10. Auditing of the following groups to ISO and project standards:Construction Management TeamConstruction ContractorsSuppliers and Vendors
11. Metrics tracking and reporting in relation to Completions, Turnover and Quality
12. Provide expertise and guidance in relation to construction QA for all construction activities onsite
13. Establish a ‘Right First Time’ culture onsite.
14. Ensure all construction activities comply with Good Manufacturing Practice requirements and regulatory standards
15. Direct daily quality activities across all construction disciplines and contractors
16. Oversee quality documentation, IQ/OQ protocols, and validation master plans
17. Coordinate internal and external quality audits, regulatory inspections, and client assessments
18. Lead investigation and resolution of quality issues and deviations
19. Monitor subcontractor quality performance and compliance with project specifications
20. Deliver quality training programs for project teams and contractors
Qualifications
21. Degree in Engineering, Science, Quality Management, or related discipline
22. Minimum 8+ years in quality management roles on major construction / engineering projects
23. Proven experience in pharma facility construction quality management
24. Deep understanding of GMP, and Belgian/EU pharmaceutical regulations
25. Extensive experience with ISO 9001, quality management systems, and validation processes
26. Fluent English essential; Dutch/French advantageous
27. Qualified internal auditor with experience managing regulatory inspections
28. Professional quality qualification advantageous
29. Experience with cleanroom construction and controlled environment validation advantageous
30. 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-GS1
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.
31. Managing Project Completions for multiple systems
32. Approval of Vendor Turnover Packages (VTOPs)
33. Approval of Trade Turnover Packages (TTOPs)
34. Coordination of Trade Walkdowns
35. Punchlist Management and closeout
36. Managing Engineering Document Control
37. Transfer of VTOPs & TTOPs to Operations
38. Receipt, review and acceptance of As Built Drawings
39. Management of Non GMP Change Controls
40. Auditing of the following groups to ISO and project standards:Construction Management TeamConstruction ContractorsSuppliers and Vendors
41. Metrics tracking and reporting in relation to Completions, Turnover and Quality
42. Provide expertise and guidance in relation to construction QA for all construction activities onsite
43. Establish a ‘Right First Time’ culture onsite.
44. Ensure all construction activities comply with Good Manufacturing Practice requirements and regulatory standards
45. Direct daily quality activities across all construction disciplines and contractors
46. Oversee quality documentation, IQ/OQ protocols, and validation master plans
47. Coordinate internal and external quality audits, regulatory inspections, and client assessments
48. Lead investigation and resolution of quality issues and deviations
49. Monitor subcontractor quality performance and compliance with project specifications
50. Deliver quality training programs for project teams and contractors
51. Degree in Engineering, Science, Quality Management, or related discipline
52. Minimum 8+ years in quality management roles on major construction / engineering projects
53. Proven experience in pharma facility construction quality management
54. Deep understanding of GMP, and Belgian/EU pharmaceutical regulations
55. Extensive experience with ISO 9001, quality management systems, and validation processes
56. Fluent English essential; Dutch/French advantageous
57. Qualified internal auditor with experience managing regulatory inspections
58. Professional quality qualification advantageous
59. Experience with cleanroom construction and controlled environment validation advantageous
60. 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-GS1