Associate Director of Validation

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