Quality Assurance Manager

AbbVie; Cincinnati (OH); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Paid time off

Medical insurance

Dental insurance

Vision insurance

401(k)

Job summary

AbbVie is seeking a Quality Assurance Manager to support manufacturing processes across pharmaceutical products, medical devices, cosmetics, and biologics. You will translate strategy into tactical objectives and lead a team of QA professionals to ensure compliance with regulatory requirements and internal standards.

The role requires excellent communication with management, hands‑on CAPA implementation, and the ability to deliver strategic plans while managing day‑to‑day QA operations at the

Qualifications

• Bachelor’s degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or related technical field preferred.
• 8+ years in quality assurance, quality oversight, or related experience.
• Leadership of technical professionals and cross‑functional teams.
• Strong knowledge of QA systems and regulatory requirements (FDA/EMA/ICH).

Responsibilities

• Provide direction to QA staff including hiring, performance feedback and development.
• Direct development of quality policies meeting regulatory and company standards.
• Maintain expertise on regulatory requirements and lead compliance at the site.
• Interface with FDA and other regulators during inspections.
• Review deviations and implement CAPA to reduce quality events.
• Produce quality metrics for senior management and drive improvements.
• Promote quality awareness and compliance across the organization.

Skills

Leadership

Regulatory knowledge

GMP compliance

Cross-functional collaboration

Education

Bachelor's degree in a technical/scientific field

Job description

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 through our Allergan Aesthetics portfolio.

Job Overview

The Quality Assurance Manager provides quality assurance support for manufacturing processes of pharmaceutical products, medical devices, cosmetics, combination products, and biologics. The role ensures 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. The Manager translates strategy into tactical objectives, delivers strategic plans and regulatory updates, and leads a team of QA professionals.

Key Responsibilities

• 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.
• Performs assessments to determine compliance to processes and regulations to identify potential gaps and mitigate and implement improvements within our quality system.
• Reviews and approves deviation investigations, driving reduction in quality events through robust CAPA
• Compiles, analyzes and communicates significant quality or compliance metrics to senior management
• Establishes programs to promote quality awareness and compliance

Qualifications

• 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.

Additional Information

• 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.

Equal Opportunity Employer

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.

Reasonable Accommodation

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html