Senior CQV & Quality Integration Lead (GMP Turnover)

Advanced Manufacturing Tech Solutions PTE. LTD. (AMTSOL); Arizona; On-site; USD 140,000 - 260,000; Full time

Job summary

AMTSOL is seeking an experienced CQV leader to drive integrated commissioning, qualification and validation for a regulated capital project in the Phoenix area. You will define boundaries, ownership and turnover pathways, and coordinate GMP impact assessments and quality risk reviews.

With 8+ years in commissioning, qualification, validation or GMP project delivery, you will manage deviation closures, data integrity and release dependencies, ensuring mechanical completion and handover readiness.

Qualifications

• Bachelor’s degree in Engineering, Science, Pharmaceutical Technology or related discipline.
• 8+ years in commissioning, qualification, validation, quality engineering or GMP project delivery, including leading system turnover and readiness.
• Documented experience on construction projects with a TIC above $30M (evidenced on CV).
• Risk-based CQV, requirements traceability, design qualification, deviation management and data integrity.

Responsibilities

• Develop the integrated CQV and quality execution strategy.
• Define system boundaries, ownership, turnover pathways and release dependencies.
• Coordinate GMP impact assessments, quality risk assessments and requirements traceability.
• Align design reviews with commissioning, qualification, validation and turnover needs.
• Define readiness criteria for mechanical completion, commissioning, qualification and handover.
• Track quality actions, deviations and prerequisite closure.
• Manage turnover-package content, indexing, review and acceptance.

Skills

CQV leadership

Quality engineering

GMP knowledge

Data integrity

Deviation management

Requirements traceability

Design qualification

Risk-based CQV

Turnover readiness

Education

Bachelor’s degree in Engineering, Science, Pharmaceutical Technology or related discipline

Job description

AMTSOL is seeking an experienced CQV leader to drive integrated commissioning, qualification and validation for a regulated capital project in the Phoenix area. You will define boundaries, ownership and turnover pathways, and coordinate GMP impact assessments and quality risk reviews.

With 8+ years in commissioning, qualification, validation or GMP project delivery, you will manage deviation closures, data integrity and release dependencies, ensuring mechanical completion and handover readiness.