Manager, Quality Systems

Cincinnati, OH, United States
Nov 21, 2020
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines 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: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions and driving results.

What Your New Manager Wants You To Know

The Manager is responsible for day to day oversight of the Quality Management Systems (QMS). He/she leads personnel and associated activities ensuring compliance with all aspects of the QMS. He/she provides support, guidance and execution for Supplier Management, Quality Management Review, Site Training QMS related, Data Integrity, Quality Risk Management, Document Control, Annual Product Review (APR), product release and self- inspection. Manager QMS also manages hiring, developing, evaluating, and counseling of his/her staff. He/she provides feedback on a regular basis and prepares formal performance evaluations.

YOU ARE more than just a title, YOU ARE...

A strategic thinker : Align and excite internal stakeholders to facilitate success through strong leadership, strategic thinking and personal drive.

First class team player : Collaborate across multiple disciplines to ensure compliance and ability to influence cross-functional teams and senior leadership.

You Will

    Following procedures, work instructions and specifications performs receipt and inspection of Manage the day-to-day activities of the QMS group consisting of auditors, compliance analysts and trainer. Establish work expectations and prioritize activities to meet AbbVie Cincinnati compliance requirements. Ensure adherence to QMS tasks and project timelines. (30%). Lead team to execute Corporate Quality Monthly Metrics, Weekly Site Metrics, and Compliance Dashboard. Present Quality Systems Review (Management Review) on a quarterly basis (10%). Participate in Quality System best practice sharing within the AbbVie organization; specifically, Quality Risk Management, Supplier Quality Management, and Data Integrity (5%). Provide oversight of the team to execute trending potential compliance and quality issues identified through Quality Systems Reviews, Annual Product Reviews and Customer Complaints, (5%). Lead group to ensure execution of regulatory requests, external (FDA), internal (corporate) audits and compliance to country (Health Canada) regulations (5%)


You Bring

Education: A bachelor's degree in biology, chemistry, engineering, pharmacy, or similar scientific discipline.

Experience: A minimum of five to seven years of experience in a pharmaceutical or related industry with a minimum of 5 years Quality Assurance experience in an FDA regulated industry. Previous supervisory experience preferred.

Knowledge, Skills, and Abilities: Incumbents must be detail-oriented, have the ability to multi-task, and possess strong organizational and communication skills. The position requires thorough understanding of pharmaceutical cGMP documentation requirements. The position requires proficiency in the use of Microsoft Word, Excel, Access, Power-Point, Outlook and Explorer. Knowledge of electronic systems for batch records and regulatory submissions is desirable.

Job Type


Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.