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Post Market QA Supervisor

4 months ago

Austin, Texas, United States AbbVie Full time

Company Description

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 immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us Follow @abbvie onTwitter,Facebook,Instagram,YouTubeandLinkedIn.
Job Description

Purpose

The Post Market Quality Supervisor works to provide leadership to the complaint analysts. The individual is considered a subject matter expert (SME) for their area of complaint management and will serve as a day-to-day resource for the team to support the group. 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. Individual will work in AbbVies global quality organization to manage pharmaceutical, medical device and combination product complaints and inquiries. Interface with internal and external AbbVie customers such as physicians, nurses, pharmacists, risk managers, purchasing agents, sales representatives, manufacturing sites, technical support, commercial organization and Pharmacovigilance regarding AbbVie product complaints. Responsible for product complaint documentation and investigations.

Responsibilities

Provide day-to-day direction and leadership for the development and implementation of systems that assure consistent application.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.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.May be required to prepare and present data during regulatory audits (FDA, EMA, Anvisa, etc) and internal audits. No description available
Qualifications
Qualifications 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.
Additional Information
Applicable only 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 ingood faith it will pay for this role at the time of this posting based on the job grade for this position. Individualcompensation paid within this range will depend on many factors including geographic location, and we may ultimatelypay 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/visioninsurance 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 benefitsthat are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent with applicable law. AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.