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Fda Contractor Jobs in California (NOW HIRING)

Extremity Care

Facilities Technician

San Diego, CA · On-site

$23.96 - $35.94/hr

Coordinate and assist with external contractors, vendors, and site service providers. * Support ... Strong understanding of cGMP, GMP, and FDA-regulated manufacturing environments. * Experience using ...

Extremity Care

Facilities Technician

San Diego, CA · On-site

$23.96 - $35.94/hr

Coordinate and assist with external contractors, vendors, and site service providers. * Support ... Strong understanding of cGMP, GMP, and FDA-regulated manufacturing environments. * Experience using ...

Extremity Care

Facilities Technician

San Diego, CA · On-site

$23.96 - $35.94/hr

Coordinate and assist with external contractors, vendors, and site service providers. * Support ... Strong understanding of cGMP, GMP, and FDA-regulated manufacturing environments. * Experience using ...

1 point system

R&D Engineer Sr.

Alameda, CA · On-site

$100K - $136K/yr

Coordinate activities with other engineering disciplines, departments, and contractors. Duties ... Ensures compliance to relevant FDA QSR, ISO guidelines (ISO 13485, ISO 14971), including 21 CFR ...

Socket.dev

Director, Software Engineering (San Diego)

San Diego, CA · On-site

$268K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Our proprietary technology, which has received FDA clearance, is designed to make blood testing ... contractors, and external development partners. * Cross-functional collaboration: Partner with ...

New

Truvian Sciences

Director, Software Engineering

San Diego, CA · On-site

$268K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Our proprietary technology, which has received FDA clearance, is designed to make blood testing ... contractors, and external development partners. * Cross-functional collaboration: Partner with ...

Truvian Sciences

Director, Software Engineering

San Diego, CA · On-site

$205 - $220/hr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Our proprietary technology, which has received FDA clearance, is designed to make blood testing ... contractors, and external development partners. * Cross-functional collaboration: Partner with ...

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Showing results 21-40

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Fda Contractor information

What is an FDA contractor?

An FDA contractor is an individual or company that provides goods or services to the U.S. Food and Drug Administration (FDA) under a formal agreement or contract. These contractors may work in a wide range of areas including research, information technology, regulatory consulting, laboratory services, or facility maintenance. FDA contractors are not direct employees of the FDA but play a crucial role in supporting the agency’s mission to protect public health by ensuring the safety, efficacy, and security of drugs, biological products, and medical devices. Their work is often governed by strict regulations and requires compliance with federal standards. Contractors are selected through a competitive procurement process to ensure quality and value.

What are the key skills and qualifications needed to thrive as an FDA contractor?

To thrive as an FDA Contractor, you need expertise in regulatory compliance, scientific analysis, and project management, often supported by a degree in life sciences or a related field. Familiarity with FDA regulations, electronic submission systems, and specialized software like eCTD or data analysis tools is typically required. Attention to detail, strong communication skills, and adaptability help contractors excel in collaborative and deadline-driven environments. These skills ensure accurate, timely submissions and effective support for FDA regulatory processes.

What are some common challenges faced by FDA contractors when working with cross-functional teams?

FDA Contractors often collaborate with diverse teams, including regulatory, quality assurance, and clinical staff. One common challenge is aligning different priorities and communication styles while ensuring compliance with regulatory standards and tight project deadlines. Success in this role requires strong organizational skills, adaptability, and proactive communication to keep projects moving smoothly and maintain regulatory integrity. Building rapport and understanding the unique needs of each department can help FDA Contractors effectively bridge gaps and facilitate teamwork.

What is the difference between Fda Contractor vs Fda Auditor?

AspectFda ContractorFda Auditor
Required CredentialsTypically requires knowledge of FDA regulations, compliance, and industry standards; certifications like RAC or CQA are commonRequires similar credentials, often with additional auditing certifications such as CQA or ISO auditor training
Work EnvironmentWorks on projects for FDA-regulated companies, often in labs, manufacturing sites, or officesConducts inspections and audits at facilities, often traveling to various sites
Employer & Industry UsageHired by pharmaceutical, biotech, or medical device companies as external consultantsEmployed by regulatory agencies or contracted to perform compliance audits for FDA oversight

In summary, Fda Contractors focus on supporting companies with compliance projects, while Fda Auditors primarily evaluate and verify adherence to FDA regulations through inspections and audits. Both roles require similar certifications and industry knowledge but differ in their primary functions and work settings.

What are popular job titles related to Fda Contractor jobs in California?

For Fda Contractor jobs in California, the most frequently searched job titles are:

What job categories do people searching Fda Contractor jobs in California look for?

The top searched job categories for Fda Contractor jobs in California are:

Fda Contractor jobs near you
Infographic showing various Fda Contractor job openings in California as of August 2026, with employment types broken down into 77% Full Time, 4% Part Time, 15% Contract, and 4% Nights. Highlights an 94% In-person, and 6% Remote job distribution.

Director, Clinical Quality Assurance - Contractor

Alumis

South San Francisco, CA

$193K - $242K/yr

Full-time

Re-posted 13 days ago

Job description

Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.

Alumis is hiring a Clinical Quality Assurance Director, (CONTRACTOR) reporting to the Executive Director, GCPQA. The role works closely with the Quality leadership and Study Execution Team members to provide ICH-GCP/GVP support for all ongoing clinical studies. This involves working closely with Clinical Operations, Clinical Development, Clinical Supply Chain, Data Management, Pharmacovigilance, Medical Affairs, Regulatory, Legal, and other teams across Alumis.

The Clinical QA Director is responsible to ensure quality is embedded throughout the lifecycle of all the ongoing clinical programs through oversight, assessment and monitoring, risk assessment tools, auditing and risk mitigations. The Director will assist with establishing Key Performance Indicators and Metrics to trend and track on the health of the clinical trials.

The role is responsible for providing the operational quality guidance for the development teams and supporting the Executive Director of GCP Quality in building the Alumis Quality organization strategy and vision.

This position requires expertise in Good Clinical and Pharmacovigilance Practices (ICH-GCP & GVP) and relevant US and EU regulations. The successful candidate will drive, promote, and embed a culture of ethics, integrity, and proactive quality management. The candidate will provide guidance and leadership to ensure that the quality function maintains the standards expected by global regulatory authorities.

Essential Duties & Responsibilities:
  • Establish and maintain the ICH-GCP Clinical QA programs, policies, and procedures.
  • Ensure ongoing clinical programs are in compliance with applicable health authority regulations, guidelines and internal Standard Operating Procedures.
  • Act as the primary ICH-GCP Clinical QA subject matter expert and point of contact for all ICH-GCP/GVP related matters and issues for the assigned studies and initiatives.
  • Establish/maintain the study specific audit plan; perform audits and lead a team of external quality auditors as needed.
  • Represent Quality on project teams, Health Authority Inspections, service providers and CROs operational meetings, and Clinical QA to Clinical QA meetings.
  • Provide quality oversight and review of key Clinical and IND/NDA enabling documents.
  • Perform reviews of clinical trial documentation for data integrity and compliance with Good Clinical Practice guidance and regulations. Conduct root cause analysis for recurring issues.
  • Support inspection readiness, plans and activities. Act as the primary liaison with Health Authority and internal/external business partners for the assigned studies and programs.
  • Support clinical service provider selection and qualification activities and develop periodic compliance/metric reports.
Qualifications:Education & Experience
  • Bachelor's or advanced degree in Biology, Chemistry, or related field.
  • Minimum 10 years of ICH-GCP/GVP Quality Assurance experience.
  • Experience with auditing (e.g. Investigator Sites, Clinical Trial Vendors, Processes).
  • Strong understanding of small molecule products with direct experience in solid oral dosage forms.
Knowledge/Skills/Abilities
  • Extensive knowledge of FDA regulations and practices, ICH guidance, and strong knowledge of global health authority regulations and practices.
  • Hands-on experience in drug life cycle management.
  • A successful track record of working with service providers and CROs.
  • Ability to make timely and sound quality decisions when faced with complex clinical, compliance, technical and regulatory considerations. Highly skilled in the ability to work with ambiguity and complexity.
  • Knowledge of Quality Management Systems; experience in implementing and managing quality systems in the pharmaceutical industry.
  • Excellent verbal and written communication skills.
  • Collaborative, analytical and interpretative skills.
  • Ability to work with minimal supervision, to set priorities to meet timelines, to motivate and influence others. Prior management experience is required.
  • Previous experience in successfully leading assigned activities within cross-functional teams.
  • Approximately 15% travel required.

This position is located in South San Francisco, CA and employees are expected to be onsite Tuesday-Thursday.

The salary range for this position is $193,000 USD to $242,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company's compensation practices.

Alumis compensation packages include generous stock option grants for all employees as well as an annual bonus program.

Other benefits include:

  • Health insurance premiums paid at 90% for employee, 80% for dependents
  • Free access to Genentech Bus & Ferry Share program
  • $100 monthly cell phone stipend
  • Unlimited PTO for Exempt employees
  • Free onsite gym and a kitchen stocked with yummy snacks and drinks!

We are a hard-working, collaborative team on a mission to transform patient's lives-- and we aspire to elevate, challenge and nurture one another along the way.

Alumis Inc. is an equal opportunity employer.