H-1B Visa Associate Director Clinical Quality Assurance Jobs
Associate Director Clinical Quality Assurance roles sit squarely within H-1B specialty occupation territory, requiring a bachelor's degree or higher in a directly related field such as pharmacy, biochemistry, or life sciences. Pharma, biotech, and CRO employers routinely sponsor H-1B visas for this level, and many file LCAs under SOC code 11-9041 or 29-9099 depending on the organization.
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Get Access To All JobsINTRODUCTION
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
The Opportunity:
Revolution Medicines is seeking an Associate Director, Clinical Quality Assurance, who will play a key role within Quality Assurance and is responsible for providing leadership and compliance support for RevMed sponsored clinical trials with respect to RevMed’s Standard Operating Procedures, applicable regulatory requirements (FDA, EU, ICH & country-specific), and current industry standards and practices.
Responsibilities
- Support the development and maintenance of applicable Quality Systems and procedures that comply with applicable GCP standards and guidelines.
- Collaborate with clinical functions (e.g., Clinical Operations, Clinical Development) to provide GCP compliance support.
- Participate in clinical study execution teams (CSETs) to enable risk-based quality management and a culture of quality and open dialogue.
- Perform quality review of clinical trial documents with a focus on compliance / regulatory requirements and risk management.
- Collaborate with internal stakeholders, external auditors, and auditees to support the planning, preparation, conduct, reporting, and closure of GCP audits.
- Provide risk-based quality oversight for clinical trial activities and perform routine clinical vendor assessments.
- Provide support for Inspection Readiness activities (e.g., TMF activities, study documentation).
- Assess and coordinate activities relevant to potential quality issues associated with GCP and clinical trial conduct including but not limited to investigations, and root cause analysis, CAPA planning and management.
- Escalate identified issues to QA Management and other relevant leadership as needed in a timely manner.
- Enable other assigned GCP or GXP related tasks, as appropriate.
- Support GCP audits and inspections of RevMed, Vendors, and clinical investigator sites by regulatory authorities or business partners.
- Build positive professional relationships and trust to support learning, respect, open communication, collaboration, and teamwork.
BASIC QUALIFICATIONS
- Bachelor’s degree in scientific or technical discipline.
- A minimum of 10+ years of experience in GCP Quality in the pharmaceutical or biotechnology industry.
- 8 years in any of the following areas: audit or audit management experience, inspection readiness, Deviation/CAPA management, or related quality management system responsibilities.
- Extensive knowledge of ICH GCP, other relevant ICH guidelines and regulatory requirements (minimally US FDA) regarding applicable drug development regulations.
- Effective communication (verbal and written).
- Ability to build and sustain positive relationships with GxP colleagues, internal stakeholders, and external partners.
- Ability to create innovative solutions to problems, while integrating stakeholder input and feedback.
- Ability to critically evaluate and troubleshoot complex problems with diligence.
- Ability to manage multiple priorities and aggressive timelines.
- Highly responsible, self-motivated professional with enthusiasm and passion for the work.
- Highly proficient with various Microsoft and other computerized systems (e.g., Word, Outlook, Excel, PowerPoint, Visio, etc.).
PREFERRED QUALIFICATIONS
- Good knowledge of Computer System Validation.
LOCATION
The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.
Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.
COMPENSATION
- Base Pay Salary Range: $186,000 — $233,000 USD
Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.
Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com.
We are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with Revolution Medicines. These scams may appear as false job advertisements or unsolicited contacts through communication or chat platforms, email, phone, or text message.
Please note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information, purchase equipment, or pay fees as part of the hiring process. All legitimate communication from Revolution Medicines will come from an official @revmed.com email address.
If you believe you’ve been contacted by someone impersonating a Revolution Medicines recruiter, please report it to careers@revmed.com so we can share these impersonations with our IT team for tracking and awareness.
INTRODUCTION
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
The Opportunity:
Revolution Medicines is seeking an Associate Director, Clinical Quality Assurance, who will play a key role within Quality Assurance and is responsible for providing leadership and compliance support for RevMed sponsored clinical trials with respect to RevMed’s Standard Operating Procedures, applicable regulatory requirements (FDA, EU, ICH & country-specific), and current industry standards and practices.
Responsibilities
- Support the development and maintenance of applicable Quality Systems and procedures that comply with applicable GCP standards and guidelines.
- Collaborate with clinical functions (e.g., Clinical Operations, Clinical Development) to provide GCP compliance support.
- Participate in clinical study execution teams (CSETs) to enable risk-based quality management and a culture of quality and open dialogue.
- Perform quality review of clinical trial documents with a focus on compliance / regulatory requirements and risk management.
- Collaborate with internal stakeholders, external auditors, and auditees to support the planning, preparation, conduct, reporting, and closure of GCP audits.
- Provide risk-based quality oversight for clinical trial activities and perform routine clinical vendor assessments.
- Provide support for Inspection Readiness activities (e.g., TMF activities, study documentation).
- Assess and coordinate activities relevant to potential quality issues associated with GCP and clinical trial conduct including but not limited to investigations, and root cause analysis, CAPA planning and management.
- Escalate identified issues to QA Management and other relevant leadership as needed in a timely manner.
- Enable other assigned GCP or GXP related tasks, as appropriate.
- Support GCP audits and inspections of RevMed, Vendors, and clinical investigator sites by regulatory authorities or business partners.
- Build positive professional relationships and trust to support learning, respect, open communication, collaboration, and teamwork.
BASIC QUALIFICATIONS
- Bachelor’s degree in scientific or technical discipline.
- A minimum of 10+ years of experience in GCP Quality in the pharmaceutical or biotechnology industry.
- 8 years in any of the following areas: audit or audit management experience, inspection readiness, Deviation/CAPA management, or related quality management system responsibilities.
- Extensive knowledge of ICH GCP, other relevant ICH guidelines and regulatory requirements (minimally US FDA) regarding applicable drug development regulations.
- Effective communication (verbal and written).
- Ability to build and sustain positive relationships with GxP colleagues, internal stakeholders, and external partners.
- Ability to create innovative solutions to problems, while integrating stakeholder input and feedback.
- Ability to critically evaluate and troubleshoot complex problems with diligence.
- Ability to manage multiple priorities and aggressive timelines.
- Highly responsible, self-motivated professional with enthusiasm and passion for the work.
- Highly proficient with various Microsoft and other computerized systems (e.g., Word, Outlook, Excel, PowerPoint, Visio, etc.).
PREFERRED QUALIFICATIONS
- Good knowledge of Computer System Validation.
LOCATION
The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.
Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.
COMPENSATION
- Base Pay Salary Range: $186,000 — $233,000 USD
Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.
Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com.
We are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with Revolution Medicines. These scams may appear as false job advertisements or unsolicited contacts through communication or chat platforms, email, phone, or text message.
Please note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information, purchase equipment, or pay fees as part of the hiring process. All legitimate communication from Revolution Medicines will come from an official @revmed.com email address.
If you believe you’ve been contacted by someone impersonating a Revolution Medicines recruiter, please report it to careers@revmed.com so we can share these impersonations with our IT team for tracking and awareness.
See all Associate Director Clinical Quality Assurance jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Associate Director Clinical Quality Assurance roles.
Get Access To All JobsTips for Finding H-1B Visa Sponsorship in Associate Director Clinical Quality Assurance
Align your credentials to specialty occupation standards
Pull your degree transcripts and map your coursework to quality systems, regulatory affairs, or pharmaceutical sciences. USCIS scrutinizes whether your specific degree field matches the AD CQA role, not just that you hold a bachelor's degree.
Search LCA filings by SOC code
Use the OFLC Wage Search to filter Labor Condition Applications under quality assurance manager and related SOC codes. This surfaces which biotech, pharma, and CRO employers have actively certified wages for roles at your level in the past 12 months.
Target employers with clinical trial infrastructure
Companies running Phase II or III clinical trials need on-site CQA leadership and file H-1B petitions at director and associate director levels far more consistently than companies without active trial programs. Focus your search on sponsors with active IND filings.
Use Migrate Mate to filter verified H-1B sponsors
Search Associate Director Clinical Quality Assurance roles on Migrate Mate to see employers with confirmed LCA filing history in your occupation, so you're not wasting applications on companies that haven't sponsored at this seniority level before.
Document your GCP and regulatory audit experience precisely
USCIS RFEs on AD CQA petitions frequently challenge whether the role truly requires a specialty degree. A detailed job offer letter citing ICH E6 compliance, 21 CFR Part 11, or FDA inspection readiness responsibilities strengthens the specialty occupation argument considerably.
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Find Associate Director Clinical Quality Assurance JobsAssociate Director Clinical Quality Assurance H-1B Visa: Frequently Asked Questions
Does an Associate Director Clinical Quality Assurance role qualify as an H-1B specialty occupation?
Yes. USCIS defines specialty occupation as a role requiring at least a bachelor's degree in a directly related field. AD CQA positions require formal training in pharmaceutical sciences, biochemistry, or regulatory affairs, and involve ICH and FDA compliance work that cannot be performed by a generalist. The O*NET profile for quality assurance managers supports this classification.
Which industries hire at the Associate Director CQA level and actively sponsor H-1B visas?
Pharmaceutical manufacturers, biotechnology firms, contract research organizations, and medical device companies are the most consistent H-1B sponsors at the associate director CQA level. These employers maintain dedicated regulatory and quality functions that require senior leadership, file LCAs regularly with DOL, and have established immigration programs. You can identify verified sponsors on Migrate Mate using LCA filing history filtered by role and location.
How does the H-1B prevailing wage requirement affect job offers for this role?
DOL requires your employer to pay at least the prevailing wage for the SOC code and geographic area listed on the LCA. For associate director CQA roles, this typically falls in the Level III or Level IV wage tier depending on supervisory scope and years of experience. You can verify the applicable wage level using the OFLC Wage Search before evaluating any offer.
Can I change employers on H-1B if I'm in a CQA associate director role?
Yes. Under H-1B portability rules, you can start working for a new employer as soon as they file an H-1B transfer petition with USCIS, provided your current status is valid and your prior petition was approved. You don't need to wait for the new petition to be approved before starting, which gives you flexibility when moving between pharma or biotech companies.
What documentation strengthens an H-1B petition for an Associate Director CQA position?
The job offer letter should cite specific regulatory frameworks the role operates under, such as 21 CFR Parts 210, 211, or 820, ICH Q10, or FDA audit readiness activities. Pairing this with academic transcripts showing coursework in pharmaceutical sciences or quality systems, plus evidence of direct supervisory responsibility, reduces the likelihood of an RFE challenging specialty occupation status.
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