Strategic Validation Lead - Pharma Manufacturing

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

Benefits offered by this job

Health benefits

401(k) with company match

Vacation and leave

Job summary

Novartis Group of Companies in Morrisville, NC seeks a Validation Lead to shape the site's validation strategy across process, cleaning, packaging, and verification activities, ensuring quality and patient safety. This role oversees the Validation Master Plan and drives readiness for inspections, regulatory submissions, and product launches.

You will own the Validation Master Plan, drive metrics, lead cross-functional teams, support product launches and tech transfers, and represent the site

Qualifications

• Bachelor's degree in Chemistry, Pharmacy, Chemical Engineering, or related field.
• 8 years in pharma manufacturing, including 5 years in process validation.
• Experience leading validation projects and governance.

Responsibilities

• Lead site validation strategy across processes and cleaning.
• Maintain Validation Master Plan and inspection readiness.
• Monitor validation metrics for compliance and excellence.
• Provide technical leadership for risk assessments and investigations.
• Collaborate with Engineering, Quality, Analytical Science & Technology, and IT on qualification interfaces.
• Support product launches and tech transfers with robust validation approaches.
• Represent site during audits, inspections, and governance.

Skills

Validation leadership

Process validation

Cleaning validation

Quality systems

Statistics

Regulatory knowledge

Cross-functional

Data analysis

Technical leadership

Education

Bachelor's degree in Chemistry/Pharma

PhD (Desirable)

Job description

Novartis Group of Companies in Morrisville, NC seeks a Validation Lead to shape the site's validation strategy across process, cleaning, packaging, and verification activities, ensuring quality and patient safety. This role oversees the Validation Master Plan and drives readiness for inspections, regulatory submissions, and product launches.

You will own the Validation Master Plan, drive metrics, lead cross-functional teams, support product launches and tech transfers, and represent the site