A biopharmaceutical company is seeking an Associate Director of Validation in Raleigh, NC. This role leads site validation activities and provides cross-functional leadership for qualification, validation, and compliance initiatives that support laboratory equipment and computerized systems.

About the Opportunity:
- Shift: Day shift
- Schedule: Monday through Friday
- Hours: Standard business
- Setting: On-site
Responsibilities:
- Lead the Validation team and provide direction to support site operational and strategic objectives
- Oversee validation projects for laboratory instruments, equipment, and systems in accordance with applicable lifecycle requirements
- Collaborate with senior leaders and cross-functional partners to support site strategy, alignment, and execution
- Represent Validation in GMP and regulatory inspections and support compliance readiness
- Drive continuous improvement, staff development, and validation culture enhancement across the site
Qualifications:
- At least 10 years of experience in a biopharmaceutical or related environment in an Engineering or Quality-related role
- At least 5 years of leadership experience
- Bachelor's degree in Life Sciences, Engineering, or a related field
- Strong knowledge of GxPs, GAMP 5, CFRs/Annex 11, and data integrity requirements
- Experience with computer system validation and the validation lifecycle
- Experience writing validation documentation, including protocols, test scripts, summary reports, and traceability matrices
- Strong technical writing skills and excellent verbal and written communication abilities
- Ability to manage multiple projects with minimal supervision in a deadline-oriented environment
Desired Skills:
- Experience with calibration and maintenance management software
- Knowledge of electronic document management systems
- Experience with root cause analysis, risk assessment, and investigation tools
- Familiarity with pharmaceutical equipment such as bioreactors, centrifuges, HVAC systems, and temperature-controlled units
