Sr. Compliance Auditor

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

TheSr. Compliance Auditor is responsible for providing quality assurance support for some or all of the following manufacturing processes: pharmaceutical products and biologics. This role will support the strategic direction to ensure business objectives are met. Specific areas of support may include supporting regulatory inspections and third party client audits.

Responsibilities

Ensure proper integration and support of quality regulations: drug andbiologicsLead project teams in planning, preparation, review and approval of quality documentation.Responsible for implementing and maintaining the effectiveness of the quality system for drug, biologics, including compliance with Corporate policies, processes and procedures.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.Manage and oversee the interrelated function activities including design control with, Manufacturing Science and Technology (MS&T), Supply Chain, Program Management, Commercial, Pharmacovigilance, and Regulatory Affairs.Coordinate quality system elements, training, continuous improvement, and tactical support across functions, plants, and affiliates.Support new product introduction for pharmaceutical products.Interact with internal and external partners for development of best practices in our quality systems and procedures.Ensure to support with regulatory responses to the observationsPerform assessments to determine compliance to processes and regulations to identify potential gaps and mitigate and implement improvements within our quality system.Oversee the implementation and management of training and education programs for various aspects of quality assurance.Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
Qualifications
Bachelors Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area preferred.8+ years experience in quality assurance, regulatory affairs, 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 orbiological.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
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law: The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees. This job is eligible to participate in our short-term incentiveprograms. This job is eligible to participate in our long-term incentiveprograms Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law. AbbVie is an equal opportunity employer and 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. US & Puerto Rico only - to learn more, visit

---