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 DescriptionProvide Quality oversight and approval regarding qualification and validation in compliance with regulatory regulations/guidelines. Administer and control the Validation program which includes equipment, processes, utilities, facilities, computers, cleaning procedures, laboratory equipment, and analytical methods to demonstrate that product will perform consistently as intended.
Responsibilities
- Responsible for the audit, pre-approval and post-approval of all process validations protocols, cleaning protocols and analytical test method protocol as the QA signature.
- Maintain and control the Validation Change Control Program for the validated/qualified systems and the Validation Management System (VMS).
- Review and approval of Validation Master Plan.
- Create validation documents, such as Soltraqs Change Plans, Validation Plans, Technical Reports and Position Papers.
- SME on process validation aspects (process changes, cleaning validation, dust controls, hold times, test method validation, analytical instrumentation qualification).
- Conduct training related to Validation, Qualification and Management of change.
- Responsible for continuous improvement aspect of process validation by developing and supporting projects to streamline process from unnecessary tasks and paperwork.
- Provide leadership and guidance for validation related CAPA activities.
- Member of the Quality Risk Management and participate in development of FMEAs and Risk Control Plans as validation SME.
- Administer the Validation Review Board.
- Bachelor Degree in Sciences (Chemistry, Biology, Microbiology, Engineering or other technical/scientific area is required.
- Eight (8) years minimum of experience in quality assurance or related field handling validated/qualified systems on a regulated industry.
- Previous experience in Quality Risk Assessment, Change Management and Cleaning Validation is highly desired.
- Previous Leadership experience, managing direct reports.
- High degree of initiative, decision-making, and responsibility which would enable
the candidate to perform efficiently with a minimum of supervision. - Exposure to FDA/DEA regulations and inspection.
- Excellent interpersonal relationships with direct reports, peers, and supervisors
- Must be fluent in Spanish and English, both verbal and written.
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
AbbVie Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about AbbVie and has not been reviewed or approved by AbbVie.
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Retirement Support — 401(k) contributions include a dollar-for-dollar match up to 6% plus an additional annual company contribution tied to age and service. Company-paid life insurance and other financial protections further strengthen long-term security.
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Parental & Family Support — Paid leave programs include up to 12 weeks at 100% for parental leave and separate paid caregiver leave, with eligibility after six months where noted. Adoption and surrogacy reimbursements and family-building resources add further support.
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Healthcare Strength — Health coverage begins on day one with medical, dental, vision, mental health, and prescription benefits, and preventive care covered at 100%. Options such as HSAs/FSAs and coverage for spouses/domestic partners and children up to age 26 broaden accessibility.
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What We Do
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first — for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuroscience, eye care, aesthetics and other areas of unmet need.
