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Associate Director Validation Jobs (NOW HIRING)

Kasmo Global

Validation engineer

College Station, TX · On-site

Reports to Associate Director, Validation Work Location College Station, TX Primary Responsibilities: * Generate VPPs, SIAs, obtain approvals and execute validation deliverables for FUSE systems and ...

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$30.5K

$102.7K

$173K

How much do associate director validation jobs pay per year?

As of Jun 5, 2026, the average yearly pay for associate director validation in the United States is $102,728.00, according to ZipRecruiter salary data. Most workers in this role earn between $70,000.00 and $141,000.00 per year, depending on experience, location, and employer.

How does an Associate Director of Validation typically collaborate with cross-functional teams during major projects?

An Associate Director of Validation works closely with departments such as Quality Assurance, Manufacturing, Engineering, and Regulatory Affairs to ensure that validation activities meet both internal standards and regulatory requirements. This often involves leading multi-disciplinary project teams, facilitating communication, and resolving challenges related to process or equipment validation. Regular meetings, joint risk assessments, and coordinated documentation are common, which helps streamline project timelines and maintain compliance. Effective collaboration is essential for successful product launches and ongoing process improvements.

What is the difference between Associate Director Validation vs Validation Manager?

AspectAssociate Director ValidationValidation Manager
CredentialsBachelor's or Master's in Life Sciences, Engineering, or related fields; often requires industry certificationsBachelor's or Master's in similar fields; certifications like ASQ or ISPE are common
Work EnvironmentLeads validation teams, oversees validation strategies, and collaborates with cross-functional departmentsManages validation projects, ensures compliance, and reports to senior management
Employer & Industry UsagePharmaceutical, biotech, and medical device industries; used in large organizationsSimilar industries; common in mid to large-sized companies for validation oversight

The Associate Director Validation typically holds a higher strategic role, overseeing validation teams and strategies, while the Validation Manager focuses on managing validation projects and ensuring compliance. Both roles require similar credentials and are vital in regulated industries, but the Associate Director has broader leadership responsibilities.

What are the key skills and qualifications needed to thrive as an Associate Director Validation, and why are they important?

To excel as an Associate Director Validation, you need in-depth knowledge of validation principles, regulatory guidelines (such as FDA, EMA), and a background in life sciences or engineering, often supported by advanced degrees. Familiarity with validation software, quality management systems (QMS), and industry-standard protocols like GAMP or ASTM E2500 is crucial. Strong leadership, project management, and cross-functional communication skills help drive teams and ensure compliance. These competencies are essential to maintain product quality, regulatory adherence, and efficient validation processes in a highly regulated environment.

What is an Associate Director of Validation?

An Associate Director of Validation is a leadership role in the pharmaceutical, biotechnology, or medical device industries responsible for overseeing validation activities. This includes ensuring that equipment, processes, and systems meet regulatory standards and function as intended. The Associate Director manages validation teams, develops validation strategies, and ensures compliance with industry regulations such as FDA and GMP. They play a key role in quality assurance and help maintain the integrity of products and processes.
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Associate Director Validation jobs near you
Associate Director, Validation

Associate Director, Validation

ProKidney

Winston Salem, NC • On-site

Full-time

Posted 24 days ago

Job description

Position Summary
The Associate Director of Validation will lead the Qualification and Validation teams at the site. Serve as a member on project steering, value stream and quality systems performance teams. Establish operational objectives and systems to drive employee engagement and alignment with other departments. Deliver on site objectives while implementing harmonized engineering systems and processes. Provide leadership support to the other sites and validation initiatives as needed. Will lead system validation projects related to authoring and executing validation documentation for laboratory instruments/equipment and systems according to the ISPE GAMP 5 Validation Life Cycle as well as 21CFR Part11 and FDA's guide to Computer Software Assurance. Documentation includes System Validation Plan, User Requirements, Risk Assessment, IQ, OQ, PQ, Test Scripts, Summary reports, Requirements Traceability Matrix (RTM), Periodic Review of Computer Systems, and Data Integrity Assessment.
Responsibilities
  • Provide leadership and direction to Validation team members, driving performance and value creation to the site function operational and strategic plans and tasks
  • Ensure adequate resourcing (capacity and capability) to accomplish site and OST objectives. Recommend solutions to alleviate constraints
  • Regularly interacts with senior management or executives on multi-department projects and challenges. Able to build coalitions for change.
  • Continuously improving the culture of the Validation team and the site
  • Represents Validation and Emergent during GMP and other regulatory agency inspections (CDC, OSHA, etc.)
  • Identify areas to drive down operations costs and improve project delivery efficiency. Develop specific investment strategies to realize these savings
  • Hands on troubleshooting and problem solving at the Gemba in support of engineering team members and operations
  • Develop and lead small and medium sized continuous improvement projects, remain involved in projects led by staff members
  • Direct support to OST head or lead annual OPEX budget for Validation department
  • Staff and System Development
  • Effective delegation and building confidence and competence within direct reports
  • Drive engagement in the technical and personal development of the Validation team and members
  • Develops strong relationships with partners (QA, Mfg., etc.) and cultivates these with all team members
  • Provide effective and collaborative cross functional leadership to facilitate development of the site strategy and delivery of site objectives
  • Champion and enhance the culture of the Validation team

Qualifications
  • Bachelor's degree. Preferred Fields of Study: Life Sciences or Engineering
  • A minimum of 10 years of experience in a biopharmaceutical or related environment in an engineering or quality related role, with at least 5 years in a leadership role
  • Expert knowledge of GxPs, GAMP, CFRs/Annex 11, and Data Integrity requirements for laboratory systems and equipment (Understanding of data integrity principles and security controls including, but not limited to audit trail reviews, user access roles, disaster recovery, business continuity, system implementation, change control, archival, retirement, etc)
  • Strong understanding of Validation Lifecycle (GAMP 5) principles
  • Experience with calibration and maintenance management software
  • Knowledge of electronic document management systems
  • Experience with data integrity practices and compliance
  • Strong technical writing skills for qualification documents, SOPs, and work instructions
  • Ability to manage multiple projects simultaneously with minimal supervision
  • Detail-oriented with excellent verbal and written communication abilities
  • Ability to adapt to changing priorities in a deadline-oriented environment
  • Significant hands-on experience and regulatory expectations knowledge with controls, automation and computer system validation.
  • Knowledge of pharmaceutical equipment, such as bioreactors, centrifuges, HVAC systems, building chillers, clean steam generators, and Temperature Controlled Units (e.g. refrigerators, freezers, and incubators) is an advantage.
  • Strong knowledge and experience in cGMP, root cause analysis, risk assessment and investigation tools/techniques.
  • Experience in writing computer system test scripts, validation protocols and summary reports

ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.
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About ProKidney

Sourced by ZipRecruiter

Industry

Biotechnology research and development

Company size

51 - 200 Employees

Headquarters location

Winston-Salem, NC, US

Year founded

2019

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