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Associate Director Validation Jobs in Raleigh, NC

MSD

Associate Director, Engineering

Durham, NC

... Validation. The Associate Director, Engineering is responsible for the maintenance and reliability of both utilities and process equipment. The scope of responsibilities includes maintenance and ...

Gilead

Assoc Director, IT Data Engineering

Raleigh, NC · Hybrid

... are seeking an Associate Director, AI Lead (D&A Digital Marketing) to lead the technical ... Build, train or fine tune ML models for business problems, validate and evaluate them for fielding ...

Gilead

Assoc Director, IT Data Engineering

Raleigh, NC · Hybrid

... are seeking an Associate Director, AI Lead (D&A Digital Marketing) to lead the technical ... Build, train or fine tune ML models for business problems, validate and evaluate them for fielding ...

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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 Jul 8, 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.

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.
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 July 2026, with employment types broken down into 1% As Needed, 66% Full Time, 30% Part Time, 1% Temporary, and 2% Contract. Highlights an 97% Physical, 1% Hybrid, and 2% Remote job distribution, with an average salary of $99,860 per year, or $48 per hour.
Associate Director, Laboratory Quality Operations

Associate Director, Laboratory Quality Operations

Alcami Corporation

Morrisville, NC • On-site

Full-time

Re-posted 12 days ago

Alcami rating

7.3

Company rating: 7.3 out of 10

Based on 5 frontline employees who took The Breakroom Quiz

Job description

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.
Are you interested in joining our team?
Job Summary
The Associate Director, Laboratory Quality Operations is accountable for driving results in a fast-paced environment by continuously challenging the performance of quality standards, systems, and operating procedures. The Associate Director, Laboratory Quality Operations provides leadership to the site Quality team who perform quality review and approval of documents, data, protocols, qualifications, change controls, deviations, investigations, complaints, corrective action activities (CAPAs), and quality audits and inspections. This leader develops short and long-range goals, metrics, and objectives; directs the implementation of quality plans and works with lab management to ensure department goals and objectives are met. The Associate Director, Laboratory Quality Operations interacts with clients and regulatory agencies regarding quality issues, audits, and inspections.
On-Site Expectations
  • 100% on-site position.
  • 1st Shift: Monday - Friday, 8:00am - 5:00pm.

Responsibilities
  • Ensures and is ultimately responsible for compliance of laboratory operations within established SOPs, FDA regulations as well as compendial requirements.
  • Collaborates with corporate quality functions to ensure site compliance with the company's Quality Management Systems (QMS).
  • Oversees QMS to ensure timely closure of deviations, investigations, corrective actions, etc.
  • Conducts thorough root-cause analysis for investigations.
  • Implements corrective and preventive actions to eliminate repeat observations.
  • Guides, instructs, and coaches members of management in compliance issues.
  • Leads regulatory inspections to ensure minimal observations.
  • Engages in client audits and client interactions.
  • Writes responses to regulatory and client audit reports.
  • Develops and implements systems to aid in efficiency and compliance improvements for the site.
  • Develops short and long-range goals and objectives for the site quality function.
  • Develops, implements, and maintains internal auditing program.
  • Ensures controlled documentation is generated, revised, approved, and maintained per corporate and regulatory agency procedures.
  • Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
  • Attracts, develops, and retains a high performing team to meet the current and evolving needs of the business through effective selection, training and development, coaching and mentoring and performance management.
  • Other duties as assigned.

Qualifications
  • Bachelor's degree (Chemistry, Biology, Microbiology) required; master's degree preferred.
  • 10-12 years of related experience required, 12+ years preferred.
  • 10+ years of pharmaceutical quality experience required.
  • 7+ years of management experience required.
  • Prior pharmaceutical experience required; prior CDMO experience preferred.
  • Prior experience with controlled substance reporting and handling, final product release, major equipment validation, validation protocol review, process validation protocol review and APRs preferred.

Knowledge, Skills, and Abilities
  • Expert knowledge of pharmaceutical regulatory requirements and cGMP required.
  • Knowledge of quality systems and processes, change control, CAPA and data integrity required.
  • Knowledge of aseptic processing of commercial or clinical parenteral required for parenteral site(s).
  • Knowledge of auditing preferred.
  • Excellent skills in leadership, coaching and influencing others, strategic planning, critical thinking and problem solving, root-cause analysis and written communication and presentation skills required.
  • Strong computer skills.

Travel Expectations
  • Up to 10% travel required.

Physical Demands and Work Environment
The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 50 pounds and occasionally lift and/or move up to 100 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level is moderate. Occasionally, employee may be exposed to airborne particles and fumes. Occasionally, employee may be exposed to chemicals. Must have the ability to wear PPE including respiratory protection as required. Employee occasionally may be exposed to moving mechanical parts and vibration. Must have a valid drivers license and reliable transportation available to travel between local sites.

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