Senior Validation Lead — Pharma Manufacturing

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

Benefits offered by this job

Health benefits

401(k) with match

Life and disability insurance

Generous leave

Job summary

DTX Pharma, a Novartis Company, seeks a Validation Lead in Morrisville, NC to drive site validation strategy across process, cleaning, packaging, and ongoing verification activities. You will own the Validation Master Plan and lead cross-functional collaborations to ensure compliance and product launches.

The role requires a PhD or advanced degree plus extensive experience in pharmaceutical validation, quality systems, and regulatory readiness.

Qualifications

• Bachelors degree in Chemistry, Pharmacy, Chemical Engineering, Pharmaceutical Technology, or a related scientific discipline.
• 8 years of experience in manufacturing/science/quality in oral solid dosage pharmaceutical manufacturing.
• 5 years of experience executing process validation and leading validation projects.
• Proven expertise in process validation, cleaning validation, and ongoing verification programs.
• Strong knowledge of quality systems, statistics, and global regulatory requirements.

Responsibilities

• Lead the site validation strategy across process, cleaning, packaging, and ongoing process and cleaning verification activities.
• Own and maintain the Validation Master Plan with timely execution and inspection readiness.
• Establish, monitor, and improve validation performance metrics to support compliance and operational excellence.
• Provide technical leadership for validation risk assessments, investigations, and complex validation challenges.
• Partner with Engineering, Quality, Analytical Science & Technology, and IT to define interfaces for qualification activities.
• Support product launches and technical transfers by defining robust validation approaches and delivering data.
• Represent the site during audits, inspections, and validation governance activities while maintaining compliance.

Skills

Applied Statistics

Change Controls

Data Analytics

Regulatory Compliance

Technical Leadership

Process Validation

Quality Systems

Cross-functional Collaboration

Education

PhD in Chemistry/Pharmacy/Chemical Engineering/Pharmaceutical Technology

Bachelor’s degree in Chemistry, Pharmacy, Chemical Engineering, Pharmaceutical Technology, or related scientific discipline

Job description

DTX Pharma, a Novartis Company, seeks a Validation Lead in Morrisville, NC to drive site validation strategy across process, cleaning, packaging, and ongoing verification activities. You will own the Validation Master Plan and lead cross-functional collaborations to ensure compliance and product launches.

The role requires a PhD or advanced degree plus extensive experience in pharmaceutical validation, quality systems, and regulatory readiness.