Supervisor, Post Marketing QA
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 www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Title: Supervisor, Post Marketing QA
The objective of this function is to ensure compliance with regulatory and corporate requirements, assure product quality and customer satisfaction,and develop and maintain operable quality systems that are cost effective.<br/>The PMQA Supervisor supervises/manages the daily activities of a department that may include the Document Center, Complaint Handling, Audit Support, Training, and CAPA areas.
•Provide direction and leadership for the development and implementation of systems that assure consistent application for a given quality system.
•Lead personnel in the application of Quality Assurance policies, procedures, projects, product launches, systems and may be required to assist with complaint handling based on business needs.
•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.
•Develop staffing requirements. Supervise/manage a combination of exempt and nonexempt employees and ensure training and development plans are current and executed.
•Make independent compliant decisions based on knowledge of regulatory requirements.
•Initiate, manage, and execute projects to continuously improve the overall effectiveness of the department.
•Manage various departmental projects, area metrics, and KPIs.
•Minimize Data Integrity errors within a quality system and assure GMP documentation standards.
•Bachelor's Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area preferred.
•5+ years' experience in quality assurance, quality oversight or relevant experience.
•1-3 years Supervisory experience, quality assurance experience preferred (solid understanding of GxP requirements)
•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.
•Project management experience-strong leadership ability, communicate quality requirements effectively and timely. Runs and manages small to medium sized quality related projects.
•Strong oral and written communication skills (with all levels of management) needed.
•Excellent interpersonal skills a plus.
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Level Code
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.