Associate Director Clinical Quality Assurance Jobs in USA with Visa Sponsorship
Associate Director of Clinical Quality Assurance roles consistently attract H-1B 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.
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Get Access To All JobsCompany Description
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
The Associate Director, Clinical QA is responsible for developing and implementing a strategy for proactive quality oversight of clinical development programs within their responsibility.
This role will ensure that R&D remains in compliance with the corporate policies and applicable worldwide regulations. The role assures inspection readiness within the scope of a Clinical Development program/system. Provide consistent and aligned consultation to R&D team members from multi-functional interactions and delivering a comprehensive QA perspective. Influencing the decision-making process to ensure quality requirements are included within improvement initiatives.
This position is accountable to the Director of Clinical Quality, RDQA. The decisions and recommendations made by the individual will directly impact adherence to applicable regulations, and thereby promote the continued success of R&D.
Responsibilities:
- Lead collaboration across TAs to ensure best practices and lessons learned are applied both within their area of responsibility as well as across TAs.
- Lead cross-functional projects and strategies that directly benefit the programs in their Therapeutic Area and identify when cross-TA opportunities can be implemented.
- Monitor new regulations and industry trends. Ensure Compliance with Regulations and Policies within AbbVie and in partnership with external collaborations as applicable.
- Identify and manage support of issues within their programs and escalate as appropriate.
- Deliver program plans to support Inspection Ready development programs.
- Coordinate internal and external compliance actions, assessments and audits that will impact their area and align support with Business Partners and QA partners.
- Lead efforts to review critical clinical documents, development approaches and engage with strategic business partners in support of a proactive CQA team with actionable understanding of the assets.
- Lead Risk Management principles and establish strong, sustainable connections across RDQA QA teams supporting assets in development, proactively engaging across RDQA, including by expanding connections to also include the business, to deliver effective mitigation strategies to critical business partner networks.
- Leverage their comprehensive understanding of the programs and upcoming development milestones to build quality into development programs early, prevent risks from impacting submissions and approvals, while increasing success during GCP inspections.
- Proactively identify, monitor, and ultimately improve the CQA organization's connections and utilization of critical Quality System Elements, applying quality by design principles across Risk Management, Change Management, and Exception Management (inclusive of planned changes, issues, and exceptions).
- Engage stakeholders in ongoing reviews of the activities, issues and achievements and build forums to ensure QA inclusion for process improvements and team awareness of proactive QA activities.
This role can be based in Lake County, IL/Irvine, CA/South San Francisco, CA/Worcester, MA.
Qualifications
- Bachelor’s degree in a physical science, life science, nursing, pharmacy or equivalent technical experience required.
- 10+ years of pharmaceutical industry experience in any combination of quality assurance/regulatory affairs/clinical research development.
- Well-developed leadership skills.
- Demonstrated application of critical thinking and the ability to independently develop and implement strategic quality solutions in support of clinical research development programs.
- The incumbent must be able to evaluate the quality of clinical operations outputs, perform assessments to identify potential gaps and recommend mitigations.
- The incumbent must be agile and able to respond rapidly to unplanned events, changing needs of development programs as well as changing regulatory requirements and expectations.
- Must be able to formulate decisions and approaches in the complex matrix world of clinical research and development with all associated business partners and functions. Strong understanding of local regulatory and legal requirements.
- Excellent communication (written and oral), influencing and persuasion skills, matrix managing without direct authority, and collaboration/negotiation for mutually beneficial outcomes.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
Company Description
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
The Associate Director, Clinical QA is responsible for developing and implementing a strategy for proactive quality oversight of clinical development programs within their responsibility.
This role will ensure that R&D remains in compliance with the corporate policies and applicable worldwide regulations. The role assures inspection readiness within the scope of a Clinical Development program/system. Provide consistent and aligned consultation to R&D team members from multi-functional interactions and delivering a comprehensive QA perspective. Influencing the decision-making process to ensure quality requirements are included within improvement initiatives.
This position is accountable to the Director of Clinical Quality, RDQA. The decisions and recommendations made by the individual will directly impact adherence to applicable regulations, and thereby promote the continued success of R&D.
Responsibilities:
- Lead collaboration across TAs to ensure best practices and lessons learned are applied both within their area of responsibility as well as across TAs.
- Lead cross-functional projects and strategies that directly benefit the programs in their Therapeutic Area and identify when cross-TA opportunities can be implemented.
- Monitor new regulations and industry trends. Ensure Compliance with Regulations and Policies within AbbVie and in partnership with external collaborations as applicable.
- Identify and manage support of issues within their programs and escalate as appropriate.
- Deliver program plans to support Inspection Ready development programs.
- Coordinate internal and external compliance actions, assessments and audits that will impact their area and align support with Business Partners and QA partners.
- Lead efforts to review critical clinical documents, development approaches and engage with strategic business partners in support of a proactive CQA team with actionable understanding of the assets.
- Lead Risk Management principles and establish strong, sustainable connections across RDQA QA teams supporting assets in development, proactively engaging across RDQA, including by expanding connections to also include the business, to deliver effective mitigation strategies to critical business partner networks.
- Leverage their comprehensive understanding of the programs and upcoming development milestones to build quality into development programs early, prevent risks from impacting submissions and approvals, while increasing success during GCP inspections.
- Proactively identify, monitor, and ultimately improve the CQA organization's connections and utilization of critical Quality System Elements, applying quality by design principles across Risk Management, Change Management, and Exception Management (inclusive of planned changes, issues, and exceptions).
- Engage stakeholders in ongoing reviews of the activities, issues and achievements and build forums to ensure QA inclusion for process improvements and team awareness of proactive QA activities.
This role can be based in Lake County, IL/Irvine, CA/South San Francisco, CA/Worcester, MA.
Qualifications
- Bachelor’s degree in a physical science, life science, nursing, pharmacy or equivalent technical experience required.
- 10+ years of pharmaceutical industry experience in any combination of quality assurance/regulatory affairs/clinical research development.
- Well-developed leadership skills.
- Demonstrated application of critical thinking and the ability to independently develop and implement strategic quality solutions in support of clinical research development programs.
- The incumbent must be able to evaluate the quality of clinical operations outputs, perform assessments to identify potential gaps and recommend mitigations.
- The incumbent must be agile and able to respond rapidly to unplanned events, changing needs of development programs as well as changing regulatory requirements and expectations.
- Must be able to formulate decisions and approaches in the complex matrix world of clinical research and development with all associated business partners and functions. Strong understanding of local regulatory and legal requirements.
- Excellent communication (written and oral), influencing and persuasion skills, matrix managing without direct authority, and collaboration/negotiation for mutually beneficial outcomes.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
How to Get Visa Sponsorship in Associate Director Clinical Quality Assurance
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.
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Get Access To All 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.
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