AbbVie · 3 days ago
Senior Specialist, Quality Systems
Worcester, MA
Full-time
Onsite
Senior Level
5+ years expAbbVie is a company dedicated to discovering and delivering innovative medicines and solutions for serious health issues. The Sr Specialist Quality Systems is responsible for providing quality assurance support for various manufacturing processes, ensuring compliance with regulations and developing effective quality systems.
BiotechnologyFinancial ServicesHealth CareMedicalPharmaceuticalVenture Capital
Responsibilities
Ensure proper integration and support of quality regulations: drug, biologics, device and/or combination products
Assist project teams in planning, preparation, review and approval of quality documentation
Responsible for developing a process to maintain citation history
Monitor changes to legislation, regulations and statutes that may impact retention and/or require changes to the AbbVie 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 as well as 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 for development of best practices in our quality systems and procedures
Perform assessments to determine compliance to processes and regulations to identify potential gaps and mitigate and implement improvements within our quality system
Contribute and prepare training and education programs for various aspects of quality assurance
Qualification
Required
5+ years' 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 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
Runs and manages small to medium sized quality related projects
Preferred
Bachelor's Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area preferred
Excellent interpersonal skills a plus
Benefits
Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k)
Company
AbbVie
AbbVie is a biopharmaceutical company focused on immunology, oncology, neuroscience, virology, and aesthetics. It is a sub-organization of AbbVie.
10001+ employees
H1B Sponsorship
AbbVie has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (273)
2024 (190)
2023 (225)
2022 (284)
2021 (186)
2020 (186)
Funding
Current Stage
Public CompanyTotal Funding
$15B2024-02-27Post Ipo Debt· $15B
2023-03-08Post Ipo Equity· $0.25M
2012-12-20IPO
Leadership Team
Robert Michael
Chairman of the Board and Chief Executive Officer
Micah Bregman
Vice President, Global Strategy and Pipeline, Allergan Aesthetics
Recent News
Labiotech UG
2026-02-07
Pharma Letter
2026-02-06
Company data provided by crunchbase