Senior Manager/Associate Director of Validation

Piper Companies is hiring a Senior Manager/Associate Director of Validation for an onsite permanent position with a global biopharmaceutical company advancing next-generation cancer therapies located in Raleigh, NC. The Senior Manager/Associate Director of Validation will lead and oversee the validation program for equipment, facilities, utilities, and processes, ensuring compliance with industry standards and supporting regulatory submissions through robust qualification strategies.

Responsibilities of the Senior Manager/Associate Director of Validation:

• Lead and manage the validation program for equipment, facilities, utilities, control systems, and process performance qualification in alignment with regulatory standards.
• Develop and maintain the site’s Validation Master Plan, ensuring consistency with cGMPs, GAMP 5, ISPE, and ICH guidelines.
• Oversee the creation, execution, and documentation of validation protocols and reports, collaborating with cross-functional teams.
• Drive compliance and data integrity for computerized systems validation (CSV), including GxP software and automation systems.
• Partner with Regulatory, Quality, and Technical teams to design and execute phase-appropriate process validation strategies supporting product registration.

Qualifications of the Senior Manager/Associate Director of Validation:

• Bachelor’s or Master’s degree in a scientific or engineering discipline; Ph.D. preferred.
• 8–12 years of experience in validation within the pharmaceutical or biopharmaceutical industry, including 2–4 years in a managerial role.
• Deep understanding of regulatory requirements and industry guidelines related to validation, including cGMPs and GAMP 5.
• Proven ability to lead cross-functional teams and operate effectively in complex or matrixed environments.
• Recognized expertise in equipment, facilities, control systems, and process validation lifecycle management.

Compensation for the Senior Manager/Associate Director of Validation:

• Salary: starting at $135,000/year
• Full Comprehensive Benefits: Health, Vision, Dental, PTO, Paid Holiday, and Sick Leave if Required by Law

This job opens for applications on 11/3/2025. Applications for this job will be accepted for at least 30 days from the posting date.

Keywords: Validation, Process Validation, Equipment Qualification, CSV, GAMP 5, cGMP, ISPE, ICH Guidelines, Data Integrity, Risk Assessment, PPQ, Quality by Design, DOE, PAT, Biopharmaceutical, Pharmaceutical Manufacturing, Regulatory Compliance, Single-Use Systems, Clean Utilities, Automation Systems, Validation Master Plan, FDA, EU Regulations, Technical Operations, MSAT, Quality Assurance, Regulatory Affairs, Process Sciences, Facility Validation, Control Systems, Lifecycle Validation

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