Data Integrity Inspection Readiness

Data Integrity Inspection Readiness Lead

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.

The Data Integrity Inspection Readiness Lead uses advanced subject matter expertise of global quality standards, cGMP, and external agency regulations to lead preparedness for regulatory inspections and audits at AbbVie sites across the global network. Drives the development and maintenance of a quality culture by closely collaborating with AbbVie Manufacturing Site leadership, Quality Lab leadership, global functional groups, and Third Party Manufacturers to conduct mock audits, coach site leadership on opportunities identified, maintain roles and responsibilities, identify potential project gaps, and obtain an in-depth understanding of the quality, compliance, and resource needs at each site. Responsible for effectively providing guidance on quality concerns and preparing all global sites in the areas of small molecule pharmaceuticals, biologics, combination products, medical devices, tissue, and cosmetics for future inspections and audits.

Focusing on data integrity, leads preparedness for regulatory inspections by ensuring AbbVie sites are compliant with global standards and regulations, conducting mock audits, and coaching site leadership on how to address opportunities identified.

Coaches site leadership and employees during external regulatory inspections and audits to empower successful data integrity audit outcomes.

Develops and executes data integrity campaigns, gap assessments, inspection readiness plans, audit observations and responses, and ensures corrective actions are appropriate.

Provides consultation, guidance, and strategic input to site and global leadership teams on initiatives that enable them to set priorities, advance quality culture, and maintain sites in an inspection-ready state while sustaining compliance.

Closely collaborates with AbbVie plant leadership, global functional groups, Third Party Manufacturers, etc., to maintain roles and responsibilities, identify potential project gaps, obtain an in-depth understanding of the data integrity compliance, and resources needs at each site, and provide guidance on quality concerns

Ensures data integrity and data traceability for all data related to new product launches, including Third Party Manufacturer's that provide products directly to distribution centers, or to AbbVie domestic and international plants for further packaging and/or testing.

Provides technical and regulatory guidance to data integrity related events across the network (i.e. observations, significant events), a key component of AbbVie's overall compliance strategy

Collaborates with Quality Centers of Excellence in reviewing regulatory intelligence and assessing company vulnerabilities against regulatory agency inspection findings

Serves as a key stakeholder for cross-functional teams to ensure we as a company achieve on-time compliance and quality deliverables, high customer value, and profitable results.

Ensures business objectives are met while maintaining compliance with local, divisional, and corporate policies as well as global external agency regulations.

Qualifications

Bachelor's Degree in relevant Life Science or other technical area required. Graduate degree desired. Advanced technical and analytical expertise required for problem resolution of technical, quality, product, and/or engineering related issues.

7+ years of experience in Quality Assurance, Regulatory, Operations, or Technical Support in a pharmaceutical or medical device setting required.

Certified Quality Auditor/ Quality Engineer and experience working with third party external manufacturers preferred.

Strong leadership background with an ability to make agile and decisive decisions.

Strong influential skills and ability to effectively operate in a fast-paced, complex organization, apply strong analytical problem-solving skills, and demonstrate strong interpersonal skills.

Strong quality assurance / control, manufacturing, laboratory, technical support, regulatory, and / or validation background is required

Ability to navigate global structure with various ways of working and provide consistent leadership when faced with obstacles to provide solutions that satisfy corporate, divisional, regional, and local objectives.

30-40% travel required.

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 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 and serving our community. Equal Opportunity Employer/Veterans/Disabled.