Head of Analytical QC & GMP Operations

TSP, a Syneos Health company; United States; On-site; USD 350,000 - 520,000; Full time

Job summary

TSP, a Syneos Health company, seeks a visionary Vice President of Analytical Operations & Quality Control to build and lead a commercial-grade GMP QC organization on our biopharma manufacturing campus in the United States.

Reporting to the chief operations executive, this role will own method validation, batch release, environmental monitoring, and data integrity, partnering with Regulatory, QA, and client programs to ensure compliance and operational excellence across all stages of development

Qualifications

• 15+ years of senior biopharma cGMP leadership.
• Expertise in analytical QC for complex biologics and gene therapies.
• Proven FDA/EMA inspection leadership experience.

Responsibilities

• Lead scalable GMP Analytical QC division and batch release.
• Oversee method validation per ICH Q2 and regulatory guidelines.
• Partner with Operations, Regulatory, and Quality Systems for inspections.

Skills

Strategic leadership

GMP/QA mastery

Regulatory inspection

Cross-functional collaboration

Education

Ph.D. or Master’s in Analytical Chemistry, Biochemistry, Molecular Biology, Virology or related field

Tools

LIMS

Job description

TSP, a Syneos Health company, seeks a visionary Vice President of Analytical Operations & Quality Control to build and lead a commercial-grade GMP QC organization on our biopharma manufacturing campus in the United States.

Reporting to the chief operations executive, this role will own method validation, batch release, environmental monitoring, and data integrity, partnering with Regulatory, QA, and client programs to ensure compliance and operational excellence across all stages of development