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Associate Director Validation Jobs in Texas (NOW HIRING)

Turner & Townsend

Associate Director

Houston, TX · On-site

Direct the development and enhancement of dashboards using Power BI, Tableau, and Looker to track ... Conducting data profiling and validation to ensure reliability before any statistical or business ...

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Associate Director Validation information

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, Assay Validation

Associate Director, Assay Validation

Baylor Genetics

Houston, TX • On-site

Full-time

Posted 19 days ago

Baylor Genetics rating

8.4

Company rating: 8.4 out of 10

Based on 6 frontline employees who took The Breakroom Quiz

25th of 120 rated laboratories

Job description

KEY RESPONSIBILITIES
  • Lead the planning, design, and execution of analytical validation studies for sequencing-based assays, including germline, somatic, and liquid biopsy applications.
  • Develop and maintain validation strategies, protocols, and reports that comply with CLIA, CAP, NYS, and internal quality standards.
  • Collaborate with Assay Development, Bioinformatics, Quality, and Product teams to align validation strategy with assay design, clinical claims, and product readiness.
  • Establish acceptance criteria, reference materials, and performance metrics to support analytical and clinical validation activities.
  • Serve as the subject matter expert for NGS validation methods, study design, assay performance characterization, and regulatory expectations.
  • Analyze validation data and provide data-driven recommendations for assay optimization, issue resolution, and launch readiness.
  • Support regulatory or laboratory inspections and contribute to responses, documentation, or corrective action plans as needed.
  • Mentor scientists at different levels and contribute to building a scalable validation function within the R&D organization.
  • Maintain up-to-date knowledge of emerging trends, technologies, and regulatory guidance in NGS assay validation and clinical genomics.
  • Perform other duties as assigned to support team and organizational objectives.
  • Comply with all company policies, procedures, and applicable regulatory requirements.

QUALIFICATIONS
Required
  • PhD. in Molecular Biology, Genetics, Genomics, or a related discipline with 6+ years of relevant experience; or M.S. with 8+ years of experience in NGS assay development and validation.
  • Demonstrated track record leading validation of clinical NGS assays under CLIA, CAP, NYS, or equivalent regulatory frameworks.
  • Strong expertise in NGS library preparation, sequencing platforms, and assay performance characterization.
  • Deep understanding of analytical validation parameters, including accuracy, precision, limit of detection, specificity, reproducibility, and related statistical evaluation.
  • Experience collaborating with bioinformatics teams for pipeline verification and integrated assay validation.
  • Familiarity with quality management systems, design control, and documentation best practices.
  • Excellent problem-solving, communication, and cross-functional collaboration skills.
  • Proven ability to lead complex projects and influence without direct authority in a matrixed environment.
  • Equivalent combination of education and experience may be considered.

Preferred:
  • Prior experience with germline clinical genetic testing or prenatal liquid biopsy testing.
  • Knowledge of NYS clinical test submission requirements or FDA IVD development processes.
  • Experience managing a small team.
  • Familiarity with automation or process scaling for NGS workflows.

COMPETENCIES
  • Scientific rigor and strong attention to detail.
  • Strategic thinking with hands-on execution capability.
  • Collaborative mindset with strong communication across scientific and business functions.
  • Commitment to quality, compliance, and continuous improvement.

PHYSICAL DEMANDS AND WORK ENVIRONMENT
  • Location: Houston, TX / Remote.
  • Work may be performed in an office, remote, and/or laboratory environment depending on business needs and assigned responsibilities.
  • May require exposure to standard laboratory conditions and adherence to applicable safety, quality, and regulatory requirements.
  • Must be able to use standard office equipment and computer systems for extended periods.
  • Travel requirements may vary based on business needs.

EEO STATEMENT
Baylor Genetics is proud to be an equal opportunity employer committed to fostering an inclusive and diverse workplace. We welcome and encourage applicants from all backgrounds to apply. We do not discriminate on the basis of race, color, religion, national origin, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, pregnancy, childbirth, or any other status protected by applicable federal, state, or local law.
Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

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