Associate Director of Validation
Tandym Group ·careers.tandymgroup.com
Apply directA 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
Frequently asked questions
Who is hiring for the Associate Director of Validation role?
Tandym Group is hiring for the Associate Director of Validation position, a Shazamme client. Apply directly on the employer's career site.
Where is the Associate Director of Validation job located?
The Associate Director of Validation role with Tandym Group is based in Raleigh, NC, US.
What does the Associate Director of Validation role pay?
Tandym Group lists the Associate Director of Validation role at USD 150,000–185,000 per year.
Is the Associate Director of Validation role full-time or contract?
This is a full time position at Tandym Group.
What experience level is the Associate Director of Validation role?
The Associate Director of Validation position is aimed at director-level candidates.
How do I apply for the Associate Director of Validation role at Tandym Group?
Apply directly on Tandym Group's career page via the Apply button on this listing. ZammeJobs links straight through to the employer's ATS — no third-party form, no resume database.