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Associate Director Validation Jobs in Washington

Pwc

Data Validation Risk - Senior Associate

Washington, DC · On-site

$77K - $202K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

... Validation Risk - Senior Associate, you will play a pivotal role in transforming raw data into ... At PwC, we recognize that conviction records may have a direct, adverse, and negative relationship ...

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Associate Director Validation information

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 Washington?

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

What job categories do people searching Associate Director Validation jobs in Washington look for?

The top searched job categories for Associate Director Validation jobs in Washington are:

What cities in Washington are hiring for Associate Director Validation jobs?

Cities in Washington with the most Associate Director Validation job openings:

Associate Director Validation jobs near you

Associate Director, External Operations, Cell Therapy - External Supply Management

AstraZeneca

Gaithersburg, MD • On-site

$115K - $173K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Re-posted 25 days ago

AstraZeneca rating

8.4

Company rating: 8.4 out of 10

Based on 45 frontline employees who took The Breakroom Quiz

22nd of 86 rated pharmaceutical

Job description

The Associate Director, External Operations, Cell Therapy - External Supply Management, leads external manufacturing partner operations. These operations span a network of CDMOs and external partners supporting cell therapy across autologous, allogeneic, in vivo, and new platforms. You will create operational governance, tech transfer, batch execution, investigations, and risk management to meet supply, quality, and cost targets. You will support programs across development, clinical, scale-up, validations, launch readiness and commercialization as portfolio evolves. You will partner crossfunctionally with CMC Product Leadership, Process Development, Quality, Regulatory, Procurement, and Finance to ensure external supply.

The role is based in Gaithersburg, MD and report to the Head of External Supply - Cell Therapy Products

You will:

  • Lead daily operational management of assigned CDMOs/external manufacturing partners to ensure performance against supply, quality, and cost targets.
  • Guide execution across tech transfer, manufacturing, release, delivery, issue resolution, deviations, investigations.
  • Be a primary operational interface across technical operations, Quality, Supply Chain, Regulatory, CMC, Program management, finance, procurement and legal
  • Lead change management implementation at external partners following CMC Product Strategy. Oversee/coordinate change control, impact assessment, and implementation plan.
  • Establish and run partner governance, including business reviews, escalation pathways, performance monitoring and action tracking
  • Translate program needs and demand plans into executable external supply plans and clear partner priorities
  • Build, accountable relationships with external partners while on execution, quality, timeline, cost and supply reliability
  • Support negotiations and content of contracts such as MSAs, SOWs, Change Orders and other commercial agreements to ensure they reflect operational scope, supply requirements, governance, milestones and cost of goods optimization. . Manage supplier's performance against the contract deliverables.
  • Oversee budget input to Program Budgets and monitor spend against budgets.
  • Promote continuous improvements of external operations processes, scorecards and way of working across the network
  • Ensure endtoend integration of physical and financial flows in SAP across CDMO operations covering master data, subcontracting, batch status/release, GR/IR, variance and WIP settlement, and KPI reporting.

You have:

  • Bachelor's degree in engineering, life sciences or related discipline is required; advanced degree preferred.
  • Minimum 8+ years' experience in biotech, pharma or advanced therapy GMP operations.
  • Experience applying lean, structural and continuous improvement to deliver more efficient and reliable operations.
  • Crossfunctional leadership, communication, and stakeholder management.
  • Experience working in and with multiple geographies and achieve success through collaboration.
  • Experience applying digital, analytics and AI-enabled workflows to improve visibility, workflow efficiency and operational execution.

Desired skills:

  • Experience in SAP and inventory to COGS.
  • At least 2 years of experience in cell and gene therapy including management of CDMOs and external suppliers.

The annual base pay for this position ranges from $115K to $173K. Our positions offer eligibility for multiple incentives an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Date Posted

13-Aug-2026

Closing Date

20-Aug-2026

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

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