Lead, Validation Strategy & Compliance (Pharma)

Novartis; Morrisville (NC); On-site; USD 126,000 - 234,000; Full time

Job summary

Novartis in Morrisville, NC seeks a Validation Lead to shape the site’s validation program across process, cleaning, packaging and verification. You will own the Validation Master Plan and drive audits, investigations and data-driven improvements to support launches, tech transfers and regulatory readiness.

This leadership role requires a strong scientific background, extensive experience in pharmaceutical validation, and the ability to lead cross‑functional teams in a fast-paced manufacturing

Qualifications

• Bachelor’s degree in a scientific discipline specified in the job posting.
• 8 years of experience in pharmaceutical manufacturing/quality roles.
• 5 years of experience executing process validation and leading validation projects.
• Proven track record leading process validation, cleaning validation, and ongoing verification.
• Strong knowledge of quality systems, statistics, and regulatory requirements.
• Experience authoring technical validation documentation.

Responsibilities

• Lead the site validation strategy across process, cleaning, packaging, and ongoing verification.
• Own and maintain the Validation Master Plan.
• Establish, monitor, and improve validation performance metrics.
• Provide technical leadership for validations and risk assessments.
• Partner with Engineering, Quality, Analytical Science & Technology, and IT to define interfaces for equipment qualification / utilities qualification, system qualification, analytical method validation.
• Support product launches and technical transfers with robust validation approaches.
• Represent the site during audits, inspections, and validation governance.

Skills

Process validation

Cleaning validation

Ongoing process verification

Validation strategy

Cross-functional leadership

Quality systems

Education

Bachelor's degree in Chemistry/Pharmacy/Engineering

PhD in Chemistry/Pharmacy/Engineering/Pharmaceutical Technology

Job description

Novartis in Morrisville, NC seeks a Validation Lead to shape the site’s validation program across process, cleaning, packaging and verification. You will own the Validation Master Plan and drive audits, investigations and data-driven improvements to support launches, tech transfers and regulatory readiness.

This leadership role requires a strong scientific background, extensive experience in pharmaceutical validation, and the ability to lead cross‑functional teams in a fast-paced manufacturing