Director - IT Quality and Regulatory Compliance

About AbbVie
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.

Director IT Quality & Regulatory Compliance Services 

Job Description

The Director of IT Quality & Regulatory Compliance Services (IT Q&RCS) is a critical leadership role accountable for developing and implementing AbbVie’s IT Q&RCS strategy in collaboration with Information Security and business compliance leadership. 

This position requires strategic thinking, risk-based decision making skills, service oriented view, significant level of integration and collaboration with various business group and functional areas (including but not limited to QA, Compliance IS, Corporate Audit and other relevant stakeholders), executive level presentation and communication skills, and the ability to set the strategic direction across AbbVie, aligned to company business risks and priorities. Through close coordination and collaboration with the business and functional groups, the Director will design and implement an effective IT Q&RCS organization which optimizes the IT quality and compliance practices of AbbVie. The Director will be responsible for overseeing multiple staff and building relationships with IT and business leaders to identify, assess and mitigate IT quality and compliance risks to the business.

This position will be responsible for:

• Defining and Executing the IT Compliance Strategy
• Establishing a Regulatory Intelligence Program for IT Compliance
• Defining, Launching and Operating IT Q&RCS services for the organization
• Defining and Executing a Sustainable Training & Audit Readiness Program
• Partnering & Influencing Key AbbVie Organizations
• Manage Human Resource Strategy for the IT Q&RCS team
• Track IT Q&RCS finances

Primary Responsibilities Include:

Define and Execute the IT Compliance Strategy

• Understand the corporation's vision, goals, and ITO’s strategies.
• Develop the IT Compliance Strategy, Roadmap and Organizational design to ensure IT compliance with new and upcoming regulations.  Scope includes: GxP, SOX, Safe Harbor, HIPAA, PCI, Data Integrity, GDRP, Commercial/ Ad Promo rules, Product Device Software applications, Infrastructure change control, Security controls, etc.
• Define Best in Industry IT SLC Policies to remain in compliance with regulations while implementing a risk-based approach for an agile BioPharma company.
• Establish an IT Management Review to include IT Compliance KPIs for internal AbbVie and with Key IT Partners (e.g. HP, Unisys, EMC). 
• Define, launch and operate IT Compliance services. Develop value-based criteria and thresholds to migrate current IT Compliance activities to incorporate IT services concepts – establish IT Compliance Service Catalogue which may include services such as:
  • Compliance Lifecycle Services
  • Assessment Services
  • Inspection Support Services
  • Strategic Planning Services
  • Advisory Services
• Develop a continuous improvement program focused on business value, process optimization, cost avoidance, cost reductions and IT “Speed to Market”

Establish a Regulatory Intelligence Program for IT Compliance

Define a Holistic Global Program around Regulatory Intelligence focused on IT Compliance

• Track, trend and share industry Warning Letters and Statements of Non-Compliance (SoNC) involving IT systems and practices.  Evaluate AbbVie’s compliance and develop and track plans to remediate.
• Develop a communication plan to disseminate key guidance, rules and standards to the organization for IT Practitioners to understand and implement.
• Best in Class Benchmarking with industry peers to establish requirements for compliance while supporting innovation and improved agility and IT “Time to Market”

Define and Execute a Sustainable Training & Audit Readiness Program

• Establish an IT Compliance Training Plan to include principles on:
  • Applicable Laws, Regulations, and Definitions
  • Global Regulatory Agencies overview
  • AbbVie’s Quality System supporting GxP requirements
  • Warning Letters and Statements of Non-conformance
  • Commercial & Ad Promo Rules
  • Internal IT Audit Process
  • Risk Based IT SLC, Agile, and Scrum techniques
  • Share audit findings and lessons learned across ITOs for continuous improvement
  • Compliance importance and impact to our patients
• Develop business ready tools to facilitate and simplify IT compliance. 
  • Prepare and establish guidelines and toolkits as Audit “Defense” packages for enterprise IT systems, infrastructure, security, plant and affiliate Audit Support
  • Establish tools and techniques for IT practitioners to translate requirements/policies/ procedures into easy to follow checklists for implementation, tailored to ITOs with a risk-based approach
  • Develop tools to track, remind and document compliance evidence for compliance areas
• Establish a program to request and support Mock Audits around new IT systems and requirements
• Establish key compliance competencies for IT:
  • Root Cause Analysis (RCA) and CAPA expertise
  • FMEA Risk Assessments
  • Mobile App Development for Non-Product and Product Device applications

Partner & Influence Key AbbVie Organizations

Build and maintain productive relationships with all levels in the AbbVie IT organization, business functions, and with external partners to support business strategies:

• Align with SQA organizations to support effective communications and define common standards across ITOs and VRBs
• Partner with AbbVie Quality Heads and represent IT in AbbVie’s Quality Council
• Communicate to and receive strategic direction from IT Senior Staff
• Guide and lead strategy and goals for the IT Compliance Managers

Manage Human Resource Strategy for the IT Q&RCS team

• Design, implement and manage the human resource strategy for the IT Q&RCS team, including succession planning, career path progression planning, leadership development, skill benchmarking, and resource prioritization and optimization for 15+/- colleague staff and a third-party service workforce
• Recruit, select and retain colleague staff including the long term development of organizational capabilities and capacity to match business demands and workloads
• Organize, prioritize and manage work assignments for IT Q&RCS team, including third-party service providers

Track Financial Performance

• Define service cost for meaningful unit of measure and calculate impact of service on AbbVie’s Profit & Loss
• Secure appropriate service financing in conjunction with other Service Managers or relevant IT leadership
• Lead annual budgeting process for all applicable cost centers
• Manage and track financial performance of the service at or below relevant value benchmark

Qualifications

Basic Qualifications:

• Bachelors degree.  MS/MBA preferred. 
• 15+ years of overall IT experience, including 5+ years focus on Compliance and Regulated Processes
• Expertise in GAMP, ISO standards, Software Development Lifecycle (SLC) processes, IT Validation practices, SQA practices, and GxP, SOX, HIPAA, etc. regulations around IT systems
• Ability to travel globally.

Preferred Qualifications:

• Ability to consistently apply a service oriented approach to IT compliance while working with various stakeholders, develop updated service processes and technology elements that are easy transition to operation
• Ability to identify and prioritize continual improvement opportunities, including developing improvement approach alternatives, opportunity cost and estimates of net benefit impact
• Ability to develop business focused balanced scorecards that articulate IT compliance level, service quality and cost

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 10 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
D
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.