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 serves to provide leadership at the site Quality Operations level to support strategic initiatives, product filings, continuous improvement, and management of the site Quality System. Quality excellence is a key strategic driver to ensure regulatory standards are understood and adhered to at the site operations level. This position holder will have responsibility for oversight of the Compliance and Regulatory activities for the site and ensure successful inspection outcomes and delivery of high quality, compliant products for the patients that we serve.
Responsibilities
Oversight of Compliance and Regulatory activities at the site operations level, specifically leadership of a team responsible for a broad range of activities:
- Inspection readiness and execution for regulatory agencies; Audit readiness and execution for client audits
- Lead internal self-inspection program to maintain compliance with AbbVie quality requirements and global standards
- Support CMC filing and response to questions; provide data and support for market expansion filings
- Ownership of client quality agreements
- Ownership of risk management programs
- Facility related support such as pest control, engineering updates, and non-process related systems
- Ownership of the site management review program
- Leading and inspiring a team of individuals, providing an exceptional employee experience through clear communication, sensible goal setting, succession planning and development planning
- Demonstrating and Promoting AbbVie culture and Ways of Working
- Intention to be part of succession plan for Site Quality Director and open to possible opportunities in the broader AbbVie network
Qualifications
- Bachelor’s degree is required; preferably in Engineering, Chemistry, Microbiology or Science related field
- 15+ years’ experience in GMP pharmaceutical, biologics and/or medical device manufacturing; 5+ years of progressive people leading experience required
- Lean Six Sigma Black Belt certification is preferred
- Skilled in strategy development, initiation, selection, coordination and management of projects and have the ability to solve unique problems.
- Advanced knowledge of cGMPs, GXP, and other regulatory standards and guidelines applicable to medical device/bio/pharmaceutical industry
- Ability to manage multiple projects and work with global cross-functional teams.
- Experience in facilitation, negotiation, and influencing skills. Ability to drive change.
- Strong verbal and written communication skills needed; excellent interpersonal skills required
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, preferably in Engineering, Chemistry, Microbiology, or a related science field
- 15+ years of experience in GMP pharmaceutical, biologics, and/or medical device manufacturing
- 5+ years of progressive people leadership experience
- Lean Six Sigma Black Belt certification
- Advanced knowledge of cGMPs, GXP, and applicable medical device, biotechnology, and pharmaceutical regulatory standards and guidelines
- Experience developing, initiating, selecting, coordinating, and managing projects
- Ability to solve unique problems and manage multiple projects
- Experience working with global cross-functional teams
- Facilitation, negotiation, influencing, and change-management skills
- Strong verbal and written communication and excellent interpersonal skills
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.
