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Associate Director of Validation

Tandym

Winston-Salem, North Carolina

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JOB DETAILS
SALARY
$150,000–$180,000
SKILLS
Biology, Biotech and Pharmaceutical, Calibration, Centrifuge, Communication Skills, Computer Skills, Computer Systems, Continuous Improvement, Cross-Functional, Data Quality, Document Management, GMP (Good Manufacturing Practices), GxP, HVAC, Laboratory Equipment, Leadership, Multitasking, Operational Strategy, Operational Support, Presentation/Verbal Skills, Process Improvement, Project Tracking, Project/Program Management, Regulations, Risk Analysis, Root Cause Analysis, Staff Development, System Validation, Team Lead/Manager, Technical Writing, Test Scripts, Time Management, Traceability, Validation Documentation, Writing Skills
LOCATION
Winston-Salem, North Carolina
POSTED
13 days ago

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
  • Schedule: Monday to 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

About the Company

T

Tandym

At Tandym Group (formerly The Execu|Search Group), we’re committed to connecting talented people like you with leading companies. With our personalized approach, you’ll never feel like just a resume when you work with us. We know that every job—and every job seeker—is different, which is why we keep the focus on you and your goals. This philosophy has allowed us to help thousands of people find career success over the last three decades, and we’re here to help you do the same.
With our extensive network of companies and full suite of direct hire recruitment and contract staffing services, you’ll have access to a variety of roles. We match talent with highly curated opportunities across healthcare, professional services, tech, and life sciences—but it goes far beyond that.
When you partner with us, we’re all in. Your goals become our goals, and we are committed to helping you reach your highest potential. From matching you with your dream role to providing resume guidance and interview prep, we’re here for the entire journey. In the constantly changing world of work, you can count on us to be by your side.
COMPANY SIZE
100 to 499 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
1985
WEBSITE
http://www.tandymgroup.com