Associate Director Clinical Quality Assurance Jobs in Irvine, CA
Associate Director Clinical Quality Assurance jobs in Irvine are concentrated in the Irvine Spectrum, the Irvine Business Complex, and the Research Park corridor, where biopharma, medical device, and contract research organizations cluster heavily. Employers actively hiring include TP-LINK, DEVX, and Alcon. Scan the live roles below and apply to whichever ones fit.
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Showing 5 of 10+ Associate Director Clinical Quality Assurance jobs
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
Primarily responsible for supporting AbbVie’s pipeline, by ensuring high-quality clinical supplies that are compliant with global regulatory requirements and standards are delivered to patients. The Senior Manager, Clinical Product Supply is primarily responsible for providing direction and quality oversight of the supply chain, including manufacturing, testing and release processes from drug substance to drug product to finished product. As a team member in interdisciplinary product development teams (e.g., CMC teams), the Senior Manager is responsible for early identification and prevention of pipeline risks by driving consensus-building across AbbVie R&D functions and external partners.
Responsibilities
List up to 10 main responsibilities for the job. Include information about the accountability and scope.
- Provide program oversight for the RDQA QA organization; includes timely communications on program strategies and issue management.
- QA representative for CMC product development teams to facilitate the approval of drug to clinical trials according to program timelines
- Lead complex global cross-functional process improvement teams.
- Provide innovative and risk-based solutions to complex technical problems.
- Support the preparation of regulatory inspections and internal audits, and represent Quality in inspections and audits.
- Write/ review/ approve exception reports, including high impact and complex ERs impacting multi-functional areas.
- Provide management of clinical supply product actions and recalls.
- Support in-licensing and collaboration activities.
- Ensure suitable quality agreements or quality aspects of contracts are in place between R&D and third-party manufacturers, third party laboratories, and other service providers and other sites.
- Interact and influence decisions of the various R&D Directors and VP as well as external customers and mentor staff.
Qualifications
- Bachelors (typically in life sciences (biology, chemistry, or engineering) and/or equivalent experience.
- Master’s degree is preferred but is not required based on commensurate experience.
- 8+ years industry experience in Quality Assurance, production, testing of active pharmaceutical ingredients, drug products, drug development or other healthcare related field; less experience considered with advanced degree.
- Broad understanding of pharmaceutical manufacturing processes (chemical and biological), analytical sciences, and worldwide -global requirements for GMP (D, EU, US) is required. Experience applicable to investigational products is preferred.
- Experience in project management and ability to manage multiple priorities. Project Management Professional (PMP) certification is preferred, but not required.
- Strong leadership, communication, and organizational skills.
- Must be able to provide and defend the quality position, and effectively problem solve complex technical and quality issues.
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 postingbased 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 orless 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 paidand 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
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
Primarily responsible for supporting AbbVie’s pipeline, by ensuring high-quality clinical supplies that are compliant with global regulatory requirements and standards are delivered to patients. The Senior Manager, Clinical Product Supply is primarily responsible for providing direction and quality oversight of the supply chain, including manufacturing, testing and release processes from drug substance to drug product to finished product. As a team member in interdisciplinary product development teams (e.g., CMC teams), the Senior Manager is responsible for early identification and prevention of pipeline risks by driving consensus-building across AbbVie R&D functions and external partners.
Responsibilities
List up to 10 main responsibilities for the job. Include information about the accountability and scope.
- Provide program oversight for the RDQA QA organization; includes timely communications on program strategies and issue management.
- QA representative for CMC product development teams to facilitate the approval of drug to clinical trials according to program timelines
- Lead complex global cross-functional process improvement teams.
- Provide innovative and risk-based solutions to complex technical problems.
- Support the preparation of regulatory inspections and internal audits, and represent Quality in inspections and audits.
- Write/ review/ approve exception reports, including high impact and complex ERs impacting multi-functional areas.
- Provide management of clinical supply product actions and recalls.
- Support in-licensing and collaboration activities.
- Ensure suitable quality agreements or quality aspects of contracts are in place between R&D and third-party manufacturers, third party laboratories, and other service providers and other sites.
- Interact and influence decisions of the various R&D Directors and VP as well as external customers and mentor staff.
Qualifications
- Bachelors (typically in life sciences (biology, chemistry, or engineering) and/or equivalent experience.
- Master’s degree is preferred but is not required based on commensurate experience.
- 8+ years industry experience in Quality Assurance, production, testing of active pharmaceutical ingredients, drug products, drug development or other healthcare related field; less experience considered with advanced degree.
- Broad understanding of pharmaceutical manufacturing processes (chemical and biological), analytical sciences, and worldwide -global requirements for GMP (D, EU, US) is required. Experience applicable to investigational products is preferred.
- Experience in project management and ability to manage multiple priorities. Project Management Professional (PMP) certification is preferred, but not required.
- Strong leadership, communication, and organizational skills.
- Must be able to provide and defend the quality position, and effectively problem solve complex technical and quality issues.
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 postingbased 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 orless 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 paidand 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
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Associate Director Clinical Quality Assurance Jobs in Irvine: Frequently Asked Questions
How do I get a associate director clinical quality assurance job in Irvine?
Focus your search on the biopharma, medical device, and contract research sectors concentrated in the Irvine Spectrum and Research Park areas, where demand for this role is strongest. Candidates with direct GCP audit experience, FDA submission support, or clinical operations oversight tend to stand out locally. Familiarity with Class II and Class III device regulations gives an added edge given the density of medical device companies in this market.
Which companies hire associate director clinical quality assurances in Irvine?
Employers hiring associate director clinical quality assurances in Irvine right now include TP-LINK, DEVX, and Alcon, based on current listings on Migrate Mate as of July 2026. Irvine's hiring base is a mix of established biopharma companies, mid-size medical device manufacturers, and CROs that maintain regional quality leadership roles locally.
Are there remote associate director clinical quality assurance jobs in Irvine?
Yes, though this role tends to be less remote-friendly than purely analytical positions because it often requires on-site audits, lab presence, and direct oversight of quality systems. About 17% of associate director clinical quality assurance openings tied to Irvine are remote or hybrid as of July 2026. Document review, regulatory writing, and vendor management components are the functions most commonly performed remotely in Irvine-based roles.
How can I get a associate director clinical quality assurance job in Irvine with little or no experience?
The most realistic path in Irvine is moving into a senior quality assurance manager or clinical quality specialist role at a mid-size medical device or biopharma company in the Irvine Spectrum area, then building toward director-level scope. CROs based in Irvine frequently hire at the manager level and promote from within, making them a strong entry point. Hands-on GCP audit experience, even in a supporting role, is the credential that opens doors most consistently here.
Which industries hire the most associate director clinical quality assurances in Irvine?
The sectors hiring the most associate director clinical quality assurances in Irvine are Technology & Software, Education, and Construction & Real Estate, based on current listings on Migrate Mate as of July 2026. Irvine's designation as a major life sciences hub in Southern California, anchored by its Research Park and Spectrum business districts, drives concentrated demand across these sectors.
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