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Associate Director Validation Jobs in Raleigh, NC

MSD

Associate Director, Engineering

Durham, NC

Associate Director - Global Engineering Solutions Our Engineers support internal and external ... Manage or support commissioning, qualification, validation interface, turnover documentation ...

Merck & Co.

Associate Director, Engineering

Durham, NC · On-site

$142 - $224/hr

Associate Director - Global Engineering Solutions Our Engineers support internal and external ... Manage or support commissioning, qualification, validation interface, turnover documentation ...

NCSU

Associate Director of Autonomous Science

Raleigh, NC · On-site +1

The Associate Director will coordinate the translation of complex scientific questions into closed ... Establish standards for controls, validation, uncertainty quantification, reproducibility, metadata ...

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All JobsAssociate Validation JobsAssociate Director Validation JobsAssociate Director Validation Jobs in Raleigh, NC

Associate Director Validation information

See Raleigh, NC salary details

$29.6K

$99.9K

$168.2K

How much do associate director validation jobs pay per year?

As of Aug 21, 2026, the average yearly pay for associate director validation in Raleigh, NC is $99,860.00, according to ZipRecruiter salary data. Most workers in this role earn between $68,000.00 and $137,100.00 per year, depending on experience, location, and employer.

What is an associate director 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.

How does an associate director 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 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 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 popular job titles related to Associate Director Validation jobs in Raleigh, NC?

For Associate Director Validation jobs in Raleigh, NC, the most frequently searched job titles are:

What job categories do people searching Associate Director Validation jobs in Raleigh, NC look for?

The top searched job categories for Associate Director Validation jobs in Raleigh, NC are:

What cities near Raleigh, NC are hiring for Associate Director Validation jobs?

Cities near Raleigh, NC with the most Associate Director Validation job openings:

Associate Director Validation jobs near you
Infographic showing various Associate Director Validation job openings in Raleigh, NC as of August 2026, with employment types broken down into 100% Full Time. Highlights an 67% In-person, and 33% Hybrid job distribution, with an average salary of $99,860 per year, or $48 per hour.

Associate Director, Analytical Sciences

implaion

Durham, NC

Full-time

Posted yesterday

New

Job description

SUMMARY

  • Clinical-stage biotech advancing antibody into Phase 2b
  • Senior scientific leader for analytical strategy — control strategy, comparability, validation, characterization through BLA
  • Direct ownership, no layers; drive the work with CDMOs and external labs

About the Position

The Associate Director, Analytical Sciences will provide scientific leadership and strategic direction for analytical sciences across the biologics development portfolio. Reporting to the Senior Director, Tech Ops, this individual will establish department-wide analytical strategies, drive late-stage analytical development, and provide technical leadership to ensure robust, phase-appropriate analytical control strategies and analytical methods. The Associate Director will also ensure phase-appropriate characterization of our products to ensure a growing state of knowledge leading all the way to a BLA filing. Working collaboratively with Analytical Project Leads and other functional leaders, the Associate Director will help integrate analytical activities across programs, strengthen technical capabilities, and prepare development programs for late-stage clinical development and eventual commercialization. This position serves as the senior scientific leader for Analytical Sciences and functions as a strategic partner to Analytical Project Leads and other functional experts. The role focuses on advancing analytical capabilities, enabling late-stage development, and ensuring scientific excellence across the portfolio while collaborating with program leaders responsible for day-to-day execution. This full-time, regular position will be located onsite in Durham, NC.

Summary of Key Responsibilities

Functional Leadership

  • Establish and evolve the Analytical Sciences strategy to support the company's growing development portfolio.
  • Develop best practices, scientific standards, and analytical governance across programs.
  • Identify opportunities to strengthen departmental capabilities, technologies, and external partnerships.
  • Mentor scientists and contribute to building a high-performing analytical organization.

Technical Leadership

  • Provide scientific leadership for analytical lifecycle management, comparability strategies, method validation, specification development, reference standard strategy, and control strategy development.
  • Guide analytical planning for late-stage clinical development, process validation, commercial readiness, and regulatory submissions.
  • Lead scientific evaluation of complex analytical challenges and recommend strategic solutions.

Cross-Program Collaboration

  • Partner with Analytical Project Leads to provide scientific consultation, establish department-wide analytical strategies, and promote consistency of analytical approaches across the development portfolio.
  • Collaborate with Cell Line Development, Upstream and Downstream Process Development, Formulation Development, Pilot Plant, Bioassay, Quality, Manufacturing, and Regulatory Affairs to ensure integrated CMC strategies.
  • Support portfolio planning by identifying cross-program opportunities, technical risks, and resource needs.
  • Support Quality in updating SOPs and procedures to be phase appropriate

External Scientific Leadership

  • Provide scientific oversight for external analytical laboratories and CROs.
  • Lead technical interactions with external partners and support due diligence, technology transfers, and regulatory inspections.
  • Evaluate emerging analytical technologies and recommend implementation where appropriate.
  • Lead investigations as necessary for out-of-trend / out-of-specification results

Required Qualifications

We are looking for professionals with the following required skills to achieve our goals:

  • Ph.D. in Chemical/Biochemical Engineering or related Biological Sciences with 6+ years of experience in the Pharmaceutical/Biotech analytical CMC industry, or B.S./M.S. in in Chemical/Biochemical Engineering or related Biological Sciences with 12 years of experience in the Pharmaceutical/Biotech industry analytical CMC industry
  • Demonstrated experience advancing biologic products through IND and clinical development
  • Experience leading multidisciplinary CMC teams in a matrix environment.
  • Experience managing CDMOs and external development partners
  • Strong understanding of CMC regulatory expectations for biologic products
  • Excellent communication, leadership, and project management skills

Preferred Qualifications

  • Experience supporting Phase 2/3 development, commercial readiness and BLA submissions
  • Experience with addressing regulatory questions from worldwide health authorities
  • Experience with technology transfer, comparability, process validation, and lifecycle management
  • Experience supporting due diligence and strategic partnerships with CROs as well as providing oversight to these companies
  • Experience working in a fast-paced biotechnology environment with multiple concurrent development programs