Associate Director Clinical Quality Assurance Jobs in USA with Visa Sponsorship
Associate Director of Clinical Quality Assurance roles consistently attract H-1B visa sponsorship from pharmaceutical, biotech, and CRO employers. A bachelor's degree in a life sciences field is the baseline requirement, with most sponsors expecting advanced credentials and GCP expertise. For detailed occupation requirements, see the O*NET profile.
See All Associate Director Clinical Quality Assurance JobsOverview
Showing 5 of 10+ Associate Director Clinical Quality Assurance jobs
Have you applied for this role?
Have you applied for this role?
Have you applied for this role?
Have you applied for this role?
Have you applied for this role?
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 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 Associate Director Clinical Quality Assurance Jobs
Target employers with established QA infrastructure
Large pharma companies and mid-size biotechs with dedicated regulatory affairs teams are far more likely to sponsor than startups. They have immigration counsel on retainer and understand the H-1B petition process for specialized QA roles.
Emphasize GCP audit experience in your application
Sponsors need to demonstrate specialty occupation status to USCIS. Documenting your GCP inspection history, FDA correspondence involvement, and CAPA oversight makes the degree-to-role connection explicit and strengthens the petition considerably.
Confirm the role is classified as specialty occupation
Clinical QA at the Associate Director level almost always qualifies, but verify the job posting requires a specific degree field, not just any bachelor's degree. A posting requiring a life sciences, pharmacy, or chemistry degree is on stronger footing.
Raise sponsorship early in the interview process
Waiting until an offer is extended creates friction. Mention your visa status during the first substantive conversation so hiring managers can loop in HR and confirm budget and timeline before both sides invest significant time.
Understand the LCA and prevailing wage process
Your employer must file a Labor Condition Application with the Department of Labor before your H-1B petition. The LCA certifies the offered wage meets prevailing wage levels for Clinical QA director-level roles in your work location.
Consider employers with cap-exempt or existing H-1B infrastructure
Employers who have sponsored H-1Bs in prior years have documented processes and are less likely to withdraw offers due to procedural uncertainty. Asking HR about prior sponsorship history is a reasonable and expected question at this level.
Associate Director Clinical Quality Assurance jobs are hiring across the US. Find yours.
Find Associate Director Clinical Quality Assurance JobsFrequently Asked Questions
Is an Associate Director of Clinical QA role considered a specialty occupation for H-1B purposes?
Yes, in nearly all cases. USCIS evaluates whether the role normally requires a bachelor's degree or higher in a specific field. Clinical QA at the Associate Director level typically requires a degree in life sciences, pharmacy, or a related discipline, and involves specialized knowledge of GCP, regulatory submissions, and quality systems, which satisfies the specialty occupation standard.
What degree do I need for an employer to sponsor me in this role?
Most employers require a bachelor's degree in life sciences, pharmacy, chemistry, or a closely related field. Many Associate Director postings prefer or require a master's degree or PharmD, particularly at larger pharmaceutical companies. A degree in an unrelated field, even combined with years of QA experience, can complicate the specialty occupation argument in an H-1B petition.
How competitive is H-1B sponsorship for Clinical QA roles specifically?
Pharmaceutical and biotech employers file H-1B petitions for Clinical QA professionals at meaningful volumes. The lottery is the main constraint, not employer willingness. Large sponsors like contract research organizations and top pharma companies often have established immigration programs. You can browse current Clinical QA openings with sponsors on Migrate Mate.
Can I transfer my H-1B to a new Clinical QA employer if I change jobs?
Yes. H-1B portability allows you to begin working for a new employer as soon as they file a transfer petition, without waiting for approval, provided you are maintaining valid status and have been in H-1B status for at least 180 days. The new employer must file a new LCA and petition, but you are not subject to the lottery again.
Do CROs or pharma companies sponsor more often for this role?
Both sponsor regularly, but large pharma companies and established CROs tend to have more streamlined processes and dedicated HR infrastructure for immigration. Smaller CROs may be willing but lack experience, which can slow the process. Mid-size biotechs with existing QA teams are also strong targets, especially those approaching clinical-stage milestones.
What is the prevailing wage requirement for sponsored Associate Director Clinical Quality Assurance jobs?
U.S. employers sponsoring a visa must pay at least the prevailing wage, which is what workers in the same role, area, and experience level typically earn. The Department of Labor sets this rate to make sure companies aren't hiring foreign workers simply because they'd accept lower pay than a U.S. worker. It varies by job title, location, and experience. You can look up current prevailing wage rates for any occupation and location using the OFLC Wage Search page.
See which Associate Director Clinical Quality Assurance employers are hiring and sponsoring visas right now.
Search Associate Director Clinical Quality Assurance Jobs