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 DescriptionThis role is primarily responsible for supporting AbbVie’s pipeline, by supporting batch disposition activities and ensuring high-quality clinical supplies that are compliant with global regulatory requirements and standards are delivered to patients. This is achieved by effectively partnering with the business, ensuring risks are mitigated appropriately and supporting efficient review of clinical supply batches to support continued uninterrupted access to clinical supplies. The successful candidate will be able to manage multiple tasks and adjust priorities based on supply needs. This position requires the ability to positively interact with multiple functional, mentor and coach peers, and quickly and effectively be able resolve batch record documentation related issues independently, ensuring schedules are maintained and material is readily available.
Responsibilities
- Review and approve batch records and release batches or analytical records.
- Write/ review/ approve processes/procedures and related documents.
- Lead/assist in the preparation and management of audits conducted by regulatory agencies, customers, and R&D GxP Compliance.
- Review draft and final regulation for impact to R&D business and incorporate procedural changes as necessary.
- Provide routine area specific management support (act as backup to manager for routine management activities).
- Support daily product release activities as applicable to the organization.
- Responsible for driving consistency and continual process improvements within PDQA through assessment and compliance of regulations and industry practice.
- Write/ review/ approve exception reports, including high impact and complex ERs impacting multifunctional areas.
- Actively lead/participate on assigned project team(s) to support the product development.
- Actively monitor the effectiveness of processes and quality of project work with management and propose and execute quality/process improvements.
- 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.
- 6+ 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.
- Supervisory/ project management experience is a plus (not required)
- Broad understanding of pharmaceutical manufacturing processes (chemical and biological), analytical sciences, and worldwide -global requirements for GMP (D, EU, US) is preferred.
- Must be able to provide and defend the quality position, and effectively problem solve complex technical and quality issues.
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 thisposting 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 long-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 anduntil 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
Skills Required
- Bachelor’s degree, typically in life sciences such as biology or chemistry, engineering, or equivalent experience
- Six or more years of industry experience in quality assurance, production, testing of active pharmaceutical ingredients, drug products, drug development, or another healthcare-related field
- Advanced degree may substitute for some industry experience
- Broad understanding of pharmaceutical manufacturing processes, analytical sciences, and global GMP requirements across the EU and United States
- Ability to provide and defend quality positions and solve complex technical and quality issues
- Master’s degree
- Supervisory or project management experience
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 — Retirement programs are portrayed as a standout, with a dollar‑for‑dollar 401(k) match up to 6% and an additional annual company contribution based on age and service. Feedback suggests this materially boosts perceived total compensation for many U.S. employees.
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Parental & Family Support — Paid parental and caregiver leave are emphasized, including up to 12 weeks of fully paid parental leave for all parents and 4 weeks of paid caregiver leave in the U.S. Feedback suggests these policies are a meaningful differentiator for employees balancing family needs.
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Leave & Time Off Breadth — Time off is described as extensive, with tiered vacation that scales with tenure, 17 company holidays, and two paid volunteer days in the U.S. Feedback suggests the breadth of leave contributes notably to overall benefits satisfaction.
AbbVie Insights
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.
