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Associate Director Validation Jobs in San Ramon, CA

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Associate Director Validation information

See San Ramon, CA salary details

$34.1K

$114.8K

$193.3K

How much do associate director validation jobs pay per year?

As of Jul 19, 2026, the average yearly pay for associate director validation in San Ramon, CA is $114,800.00, according to ZipRecruiter salary data. Most workers in this role earn between $78,200.00 and $157,600.00 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 San Ramon, CA look for? The top searched job categories for Associate Director Validation jobs in San Ramon, CA are:
What cities near San Ramon, CA are hiring for Associate Director Validation jobs? Cities near San Ramon, CA with the most Associate Director Validation job openings:
Associate Director Validation jobs near you
Infographic showing various Associate Director Validation job openings in San Ramon, CA as of July 2026, with employment types broken down into 1% As Needed, 67% Full Time, 30% Part Time, 1% Temporary, and 1% Contract. Highlights an 97% Physical, 1% Hybrid, and 2% Remote job distribution, with an average salary of $114,800 per year, or $55.2 per hour.
Associate Director, Trial Master File

Associate Director, Trial Master File

Structure Therapeutics

South San Francisco, CA • On-site

$40.25 - $55/hr

Full-time

Medical, Dental, Vision, Retirement, PTO

Re-posted 27 days ago

Job description

About Us:
Structure Therapeutics develops life-changing medicines for patients using advanced structure-based and computational drug discovery technology. The company's platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs. We are advancing a clinical-stage pipeline of differentiated treatments focused on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions.
Structure Therapeutics is led by an experienced group of international drug innovators and financed by top-tier global life sciences investors. The company completed an initial public offering (IPO) in February 2023. With offices in California and Shanghai, Structure Therapeutics has the benefit of being at the center of life science innovation in both the US and China and capitalizing on the strengths of each geographic location.
Position Summary:
The Associate Director, Trial Master File at Structure Therapeutics will report to a Director, Vendor Oversight and Process Improvement and The Associate Director, Trial Master File (TMF) is responsible for the strategic oversight, governance, and continuous improvement of the electronic Trial Master File across the clinical trial portfolio. This role ensures that TMF processes, systems, and controls support inspection readiness, regulatory compliance, and efficient clinical trial execution.
The Associate Director provides leadership over TMF strategy, vendor oversight, inspection preparedness, and cross-functional alignment, ensuring TMF completeness, quality, and timeliness throughout the study lifecycle. The role serves as a key partner to Clinical Operations, Quality, Regulatory Affairs, and external vendors, maintaining sponsor accountability for TMF integrity while enabling scalable operations as the organization grows.
Job Responsibilities
  • Provide strategic leadership and sponsor oversight for the electronic Trial Master File (eTMF) across all clinical studies
  • Ensure TMF completeness, accuracy, and timeliness throughout the study lifecycle to support continuous inspection readiness
  • Lead the development, implementation, and maintenance of TMF governance, including SOPs, work instructions, and guidance
  • Establish and monitor TMF performance metrics and KPIs, using data to identify trends, risks, and improvement opportunities
  • Oversee CRO and vendor TMF activities, ensuring delegated responsibilities are executed in compliance with contractual and regulatory expectations
  • Serve as the TMF subject matter expert for audits, health authority inspections, and regulatory interactions
  • Drive risk-based TMF oversight, issue management, and CAPA development related to TMF quality or compliance gaps
  • Partner cross-functionally with Clinical Operations, Quality, Regulatory Affairs, and IT to ensure alignment and effective oversight
  • Lead or support TMF system implementation, optimization, and integration activities, including validation and change management
  • Develop and deliver TMF training and guidance for internal teams and external partners
  • Ensure clear documentation of sponsor oversight and decision-making in accordance with ICH GCP and regulatory expectations
  • Support scalability and operational maturity of TMF processes as the clinical portfolio grows
  • Mentor and guide TMF team members or contractors, as applicable

Qualifications:
  • Bachelor's degree or higher in a scientific or health-related discipline. Advanced degrees preferred.
  • Minimum of 8-10 years of clinical research experience within a pharmaceutical, biotech, or CRO setting.
  • Demonstrated expertise in eTMF governance, inspection readiness, and regulatory compliance
  • In-depth knowledge of ICH GCP (E6 R2/R3), TMF Reference Model, and global regulatory expectations
  • Proven experience operating within a CRO-heavy or outsourced clinical trial model, including sponsor oversight and vendor management
  • Strong experience with eTMF systems (e.g., Veeva Vault, Trial Interactive, Wingspan) and TMF metrics/KPIs
  • Track record of supporting audits and health authority inspections as a TMF subject matter expert
  • Experience developing and implementing SOPs, work instructions, and governance frameworks
  • Ability to assess TMF risk, manage issues and CAPAs, and drive continuous improvement initiatives
  • Strong cross-functional collaboration skills, with the ability to influence without direct authority
  • Excellent written and verbal communication skills, including executive-level presentation and storytelling
  • Demonstrated leadership, organizational, and change-management capabilities in a growing biotech environment

Desired Skills & Competencies:
  • Deep expertise in eTMF management, governance, and lifecycle oversight
  • Strong understanding of ICH GCP (E6 R2/R3) and health authority expectations related to TMF
  • Ability to interpret and apply the TMF Reference Model pragmatically
  • Proven inspection-readiness mindset with the ability to defend TMF strategy and decisions
  • Demonstrated ability to provide effective sponsor oversight in outsourced/CRO-led models
  • Strong risk identification, assessment, and mitigation skills related to TMF quality and compliance
  • Experience managing TMF issues, deviations, and CAPAs
  • Ability to distinguish true TMF risk vs. noise using data and judgment
  • Ability to lead through influence across cross-functional and vendor teams
  • Confident decision-making balanced with appropriate escalation
  • Capability to mentor, guide, and set expectations for TMF staff and contractors
  • Strong stakeholder management skills, including communication with senior leadership
  • Excellent written and verbal communication skills, including clear, concise executive-level messaging
  • Ability to translate detailed TMF data into meaningful insights and narratives
  • Skilled at presenting complex issues with clarity during audits and inspections
  • Proven experience developing and implementing SOPs, work instructions, and governance models
  • Strong change-management skills in evolving or scaling organizations
  • Ability to balance structure with agility in a growing biotech environment
  • Highly collaborative, with the ability to work effectively across Clinical Operations, Quality, Regulatory, and IT
  • Detail-oriented with strong organizational and prioritization skills
  • Comfortable operating in fast-paced, ambiguous environments while maintaining compliance

Travel Required: Up to 20%
Structure Therapeutics Inc. is an Equal-Opportunity Employer.
Structure Therapeutics is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $163,000 - $200,000.
The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's geography, qualifications, skills, and experience.
At Structure, base pay is only one part of your total compensation package. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Structure Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, unlimited PTO, and a number of paid holidays including winter shutdown.
Notice to Recruiters/Staffing Agencies
Recruiters and staffing agencies should not contact Structure Therapeutics through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees.
We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file.
Structure Therapeutics' receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Structure Therapeutics and such organization and will be considered unsolicited and Structure Therapeutics will not be responsible for related fees.
Fraud Alert
To all candidates: your personal information and online safety are a top priority for us. At Structure Therapeutics, direct candidates to apply through our official career page at BambooHR.
Recruiters will always contact you using the domain of Structuretx.com. We will never request payments, ask for financial account information or sensitive information like social security numbers. If you are unsure if a message is from Structure Therapeutics, please email human resources.

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