Pharmaceutical Validation Manager

About the role

The Validation Manager leads the end-to-end planning, coordination, and execution of a portfolio of site projects focused on process and product validation, product and technology transfer, and validation and qualification workstreams. This role partners closely with cross-functional stakeholders to ensure all projects are delivered on time, within scope, and within budget, while maintaining robust GMP documentation and a constant state of inspection readiness. The Validation Manager provides strategic oversight, technical guidance, and leadership to ensure that validation activities support compliant, efficient, and reliable pharmaceutical manufacturing operations.

Responsibilities

• Lead the end-to-end planning, coordination, and execution of process and product validation projects across the site.
• Manage a portfolio of validation, qualification, and technology transfer projects, ensuring they are delivered on time, within scope, and within budget.
• Oversee product transfer and technology transfer activities to ensure smooth and compliant integration into manufacturing operations.
• Develop, review, and approve validation protocols, reports, and related GMP documentation to meet regulatory and internal quality standards.
• Ensure validation and qualification workstreams comply with current Good Manufacturing Practices (cGMPs), FDA regulations, and pharmaceutical industry standards.
• Collaborate with cross-functional teams, including manufacturing, quality, laboratory, and technical functions, to align project goals and resolve issues.
• Provide leadership and direction to project teams, assigning responsibilities, monitoring progress, and driving accountability for deliverables.
• Maintain a high standard of inspection readiness by ensuring documentation, processes, and systems are consistently audit-ready.
• Identify risks, issues, and dependencies within validation and transfer projects and implement effective mitigation and corrective actions.
• Continuously improve validation and technology transfer processes by applying best practices and lessons learned from previous projects.
• Communicate project status, risks, and outcomes to stakeholders and leadership in a clear and timely manner.
• Support training and mentoring of team members and stakeholders on validation principles, cGMP requirements, and related procedures.

Requirements

• Bachelor's degree in Chemistry, Biology, or a similar scientific discipline.
• 5+ years of experience in the pharmaceutical industry.
• 5+ years of leadership and project management experience, including leading cross-functional initiatives.
• Demonstrated experience in validation and technical transfer, including process and product validation and technology transfer activities.
• Strong knowledge of cGMPs, FDA regulations, and pharmaceutical industry practices.
• Proven ability to manage multiple projects simultaneously and deliver them on time, within scope, and within budget.
• Experience preparing, reviewing, and managing validation protocols, reports, and related GMP documentation.
• Ability to collaborate effectively with manufacturing, laboratory, and other technical and quality functions.
• Strong organizational, planning, and coordination skills with a focus on inspection readiness.
• Excellent communication and leadership skills, with the ability to guide and influence cross-functional teams.

Additional Qualifications

• Experience working in a pharmaceutical manufacturing environment.
• Experience in laboratory or analytical environments supporting validation activities.
• Familiarity with process validation strategies and lifecycle approaches.
• Experience supporting or leading regulatory inspections or internal audits.
• Ability to drive continuous improvement in validation and technology transfer processes.
• Strong problem-solving skills and the ability to identify and mitigate project risks.
• Comfort working with multiple stakeholders and balancing competing priorities.

Work Environment

The role operates within a regulated pharmaceutical environment that adheres to cGMPs, FDA regulations, and established industry practices. You will work closely with manufacturing, laboratory, quality, and technical teams, often coordinating activities across multiple workstreams and projects. The position involves extensive interaction with validation documentation, protocols, and reports, as well as regular collaboration with cross-functional stakeholders to ensure inspection readiness and compliant operations. The work setting emphasizes structured processes, documentation rigor, and a strong focus on quality and regulatory compliance.

This is a permanent, fully onsite position based in Cherry Hill, NJ.

Pay

The pay range for this position is $90,000.00 - $155,000.00 per year.

Benefits

• Generous paid time off (PTO) bank starting with 20 days (prorated based on hire date), with additional days granted upon reaching work milestone anniversaries.
• 3 personal days (prorated based on hire date).
• 11 company-paid holidays.
• Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits.
• Employee discount program.
• Wellbeing rewards program.
• Safety and Quality as a top organizational priority.
• Career advancement and growth opportunities.
• Tuition reimbursement.
• Paid maternity and parental leave.