E-3 Visa Associate Director Clinical Quality Assurance Jobs
Associate Director Clinical Quality Assurance roles qualify for E-3 visa sponsorship as specialty occupations requiring a bachelor's degree or higher in a life sciences or related field. Australian professionals in clinical QA can pursue U.S. positions at biotech, pharmaceutical, and medical device companies, with no lottery and indefinite two-year renewals.
See All Associate Director Clinical Quality Assurance JobsOverview
Showing 5 of 9+ 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 9+ 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 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
See all 9+ 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 E-3 Visa Sponsorship as an Associate Director Clinical Quality Assurance
Align your credentials to U.S. specialty occupation standards
Your Australian bachelor's degree in pharmacy, biochemistry, or a related life science is accepted as equivalent to a U.S. four-year degree. Request an official transcript and, if your degree title differs from U.S. norms, prepare a credential evaluation from a NACES-recognized agency.
Target employers with active GCP compliance programs
Pharmaceutical and biotech companies running FDA-regulated clinical trials need dedicated QA leadership and are accustomed to sponsoring E-3 holders. Filter your search by companies with active IND or NDA submissions, as these organizations have established hiring infrastructure for international clinical quality professionals.
Use Migrate Mate to find E-3 sponsoring employers
Migrate Mate surfaces Associate Director Clinical Quality Assurance roles at companies with E-3 sponsorship history, so you're not cold-applying to employers unfamiliar with the process. Use Migrate Mate's E-3 filing service to handle your LCA and visa paperwork once you have an offer.
Clarify the LCA wage tier with your hiring manager
Your employer files a Labor Condition Application with the DOL before you can proceed to the consulate. At the Associate Director level, the DOL typically maps this role to wage level III or IV, so confirm the offered salary meets the prevailing wage for your specific work location before signing.
Prepare a specialty occupation justification for your role
Consular officers occasionally request evidence that the role requires a degree in a specific field, not just any bachelor's. Document how your QA responsibilities, such as CAPA oversight, audit management, and regulatory submissions, directly require your life sciences degree to satisfy specialty occupation requirements.
Time your visa interview around FDA inspection cycles
Many clinical QA directors are hired in response to upcoming regulatory inspections or consent decrees, creating compressed timelines. Book your consulate appointment as soon as your employer certifies the LCA, since Australian consulate wait times can run several weeks and inspection deadlines won't move.
Associate Director Clinical Quality Assurance jobs are hiring across the US. Find yours.
Find Associate Director Clinical Quality Assurance JobsAssociate Director Clinical Quality Assurance E-3 Visa: Frequently Asked Questions
How do I find Associate Director Clinical Quality Assurance jobs with E-3 sponsorship?
Migrate Mate is the most direct way to search for Associate Director Clinical Quality Assurance roles where employers are open to E-3 sponsorship. Standard job boards rarely flag sponsorship willingness, which means a lot of wasted applications. Migrate Mate filters by companies with E-3 filing history so you can focus on roles where sponsorship is already on the table.
How much does it cost to get an E-3 visa?
Migrate Mate's E-3 filing service covers the entire process for $499, including the Labor Condition Application, visa document preparation, and consulate appointment guidance. Traditional immigration lawyers charge $2,000–$5,000+ for the same work. The E-3 has less paperwork than most work visas, so paying thousands for legal help is usually unnecessary.
Does an Associate Director Clinical Quality Assurance role qualify as a specialty occupation for E-3 purposes?
Yes. An Associate Director of Clinical Quality Assurance requires at minimum a bachelor's degree in a life science, pharmacy, or a closely related field, which satisfies the E-3 specialty occupation requirement. The role's responsibilities, including SOP governance, GCP auditing, and CAPA oversight, are all degree-dependent functions that USCIS and consular officers consistently recognize as qualifying.
How does the E-3 visa compare to the H-1B for clinical QA professionals?
The E-3 visa is available only to Australian citizens, but it has a significant structural advantage: there is no lottery. H-1B requires registration and a random selection each April, meaning qualified candidates are turned away by chance alone. The E-3 has an annual allocation of 10,500 visas that has never been fully utilized, so a qualified clinical QA professional with an offer can proceed to the consulate without waiting for a lottery result.
Can I change employers while on an E-3 in a clinical QA role?
Yes, but your E-3 status is tied to your specific employer and position. When you move to a new company, your new employer must file a fresh LCA with the DOL and you'll need to attend a new consulate interview or file a change of status if you're already in the U.S. Your current E-3 remains valid until its expiry date, giving you a window to manage the transition.
See which Associate Director Clinical Quality Assurance employers are hiring and sponsoring visas right now.
Search Associate Director Clinical Quality Assurance Jobs