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Associate Director of Validation

Winston-Salem, NC, US • Posted 2 days ago • Updated 48 minutes ago

Full Time

On-site

$150000 - $180000 per annum

Fitment

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Associate Director of Validation

Summary

A biopharmaceutical company is seeking an Associate Director of Validation in Winston-Salem, 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

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: EXECUSCH
Position Id: PR510758-425
Posted 2 days ago

Contact the job poster

Dee Griffith

Recruiter @ Tandym Tech

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