Quality Systems Senior Specialist

About Abb Vie

Abb Vie’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, neuroscience, and products and services in our Allergan Aesthetics portfolio.

The Senior Specialist, Quality Systems is responsible for providing quality assurance support for pharmaceutical products, medical devices, combination products, and biologics. The role covers the Document Center, Device QA, Labeling, Validation, Training, CAPA, and ensures all product, process, or system-related quality activities—from raw material inspection through shipment of the final product—are in compliance with corporate and governmental regulations.

• Ensure proper integration and support of quality regulations: drug, biologics, device, and/or combination products.
• Assist project teams in planning, preparing, reviewing, and approving quality documentation.
• Develop a process to maintain citation history.
• Monitor changes to legislation, regulations, and statutes that may impact retention and/or require changes to the Abb Vie Record Retention Schedule.
• Create quality system documentation and specifications with guidance from technical teams following approved templates and guidelines.
• Complete and route change requests for process document creation, maintenance, and implementation.
• Design effective quality systems, procedures, and/or processes within cross‑functional teams to ensure compliance and efficiency throughout our quality system; may be required to prepare and present data during regulatory audits (FDA, EMA, Anvisa, etc.) and internal audits.
• Interact with internal and external partners to develop best practices in our quality systems and procedures.
• Perform assessments to determine compliance with processes and regulations to identify potential gaps and implement improvements within our quality system.
• Contribute to and prepare training and education programs for various aspects of quality assurance.
• Run and manage small to medium‑sized quality‑related projects.

• Bachelor’s degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or other technical/scientific area preferred.
• At least 5 years of experience in quality assurance, quality oversight, or relevant experience.
• Technical knowledge in as many of the following areas as possible:
  Quality, Regulatory, Process Sciences, Manufacturing Operations.
• Knowledge and familiarity with the 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 both in team settings and independently; works well with manager guidance while able to manage own time.
• Strong oral and written communication skills needed.
• Excellent interpersonal skills a plus.

Applicable 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 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 until paid, and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

Abb Vie 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

US & Puerto Rico applicants seeking a reasonable accommodation,  to learn more: