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 at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Implement, lead, and manage an effective GxP Data Governance Program. The role is responsible for ensuring compliance with all regulatory and AbbVie requirements related to data integrity across multiple departments. The data integrity lead will implement a site strategy in compliance with regulatory and AbbVie global expectations, align site initiatives, and participate on the global Data Integrity Center of Excellence
Responsibilities:
•Implement and maintain Data Integrity compliance activities across the end-to-end product lifecycle and various departments in alignment with relevant regulatory regulations and guidelines.
•Represent AbbVie as the Quality Assurance subject matter expert during internal and external regulatory inspections related to data integrity. Work with external and internal partners to ensure best in class practices for data integrity.
•Develop training material and lead training efforts with SMEs.
•Manage remediation efforts, utilizing QRM based principles to identify risk and establish appropriate prioritization.
•Provide adjunct oversight of data integrity compliance for software development and validation lifecycle activities associated with GxP computerized systems to ensure conformance to cGxPs, guidance documents, applicable industry accepted standards and AbbVie business requirements.
•Identification and prioritization of business benefit/opportunity
•Effectively manage and execute strategic business opportunities to improve business processes.
•Participate in the Data Integrity Center of Excellence and implement CoE initiatives, as required.
•Provide day to day oversight for the governance, management and coordination of activities related to Data Integrity.
Keep current on data integrity compliance and incorporate changes to continuously improve practices and procedures.
Qualifications:
Bachelor’s Degree required; preferably in Physical or Life Sciences, Pharmacy, or Engineering
•8+ years of combined experience in Manufacturing, QA, R&D in pharmaceutical, biologics, device or chemical industry
•Must be familiar with use of electronic document management and laboratory information management.
•Must also be familiar with AbbVie Quality Systems as well as cGMP and other regulatory requirements.
•Strong communication Skills, both oral and written
.•Expert knowledge of US Code of Federal regulations and the EU regulations
•Subject Matter Expertise on Data Integrity principles, computerized systems and compliance activities related to system validation.
•Excellent communication and influencing skills at all levels of the organization are required to influence diverse, ad hoc teams of SMEs.
•Demonstrated project management skills and ability to lead effective change management.
•Understanding of Software Quality Assurance and Validation principles
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 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 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 benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable 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 AbbVie’s 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.
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