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 DescriptionThe Quality Assurance Manager is responsible for providing quality assurance support for some or all of the following manufacturing processes: pharmaceutical products, medical devices, cosmetics, combination products and biologics. This role will support the strategic direction to ensure business objectives are met. Specific areas of support may include the Document Center, Device QA, Labeling, Validation, Training, Quality Intelligence, Compendia management and CAPA. This position will also translate strategy into tactical objectives to deliver strategic plans and regulatory updates. This position will ensure that all product, process or system related quality activities from raw material inspection through shipment of final product are in compliance with Corporate and governmental regulations.
- Provides direction to staff of professionals to include hiring, setting performance expectations, performance feedback and development of staff
- Directs the development of Quality policies that meet both regulatory and company requirements.
- Maintains expertise on various regulations (FDA, EMA, ICH, etc.)
- Provides compliance leadership to the manufacturing site.
- Provides direct interface with FDA and other regulatory agencies and customers during inspections.
- Perform assessments to determine compliance to processes and regulations to identify potential gaps and mitigate and implement improvements within our quality system.
- Review and approve deviation investigations, driving reduction in quality events through robust CAPA
- Compiles, analyzes and communicates significant quality or compliance metrics to senior management..
- Establish programs to promote quality awareness and compliance
•Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area preferred.
•8+ years’ experience in quality assurance, quality oversight or relevant experience.
•Leadership of technical professionals and in leading cross-functional teams.
•Technical knowledge in as many of the following areas as possible: Quality, Regulatory, Process Sciences, Manufacturing Operations.
•Knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical, biological or device related products.
•Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device, biologics, and pharmaceutical products.
•Experience working in both team setting and independently. Works well with manager guidance while able to manage own time.
•Strong oral (with all levels of management) and written communication skills needed.
•Excellent interpersonal skills a plus.
•Can lead medium to larger sized projects with increasing level of complexity and size to deliver tactical results that support strategic initiatives.
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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 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 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
Skills Required
- Bachelor's degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area
- 8+ years' experience in quality assurance, quality oversight, or relevant experience
- Leadership experience directing technical professionals and leading cross-functional teams
- Technical knowledge across Quality, Regulatory, Process Sciences, and Manufacturing Operations
- Familiarity with product, process, equipment, and facilities for pharmaceutical, biological, or device products
- Knowledge of QA systems and GMP compliance requirements, including regulations affecting device, biologics, and pharmaceutical products
- Ability to work both in teams and independently and manage own time
- Strong oral and written communication skills with all management levels
- Excellent interpersonal skills
- Ability to lead medium to large projects of increasing complexity to deliver tactical results supporting strategic initiatives
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.
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.
