Director, IT Quality and Compliance

5 - 7 years experience  •  Biotech/Pharma

Salary depends on experience
Posted on 09/22/17
Alameda, CA
5 - 7 years experience
Salary depends on experience
Posted on 09/22/17



Primary Job Function
Responsible for the IT portfolio for multiple business sectors across geographic areas. Influences and shapes the portfolio to enhance organizational strategy and global information management through successful, consistent, and predictable delivery of programs, projects and applications. Achieves this through an IT demand governance organization which partners with the business, has excellent understanding of the business strategies and processes,  and is aware of the evolution of technologies, and takes into account regulations relevant to the business area. Represent Abbott strategically in the industry and community

Core Job Responsibilities
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

Strategic Thinking: 

  • Understands and contributes to sector strategy and translates business strategy into an aligned IT strategy and portfolio of programs, projects and applications.
  • Champion change and innovation. Stimulates creativity and innovation in others. Open to new ideas. Supports those who initiate change and take risks.  Promotes a Global Perspective.
  • Constant awareness of evolving regulatory requirements and their applicability to the business process and IT portfolio, and influences the IT stakeholders and partners in addressing these evolutions in the most efficient way.

Business Acumen: 

  • Understands the business of the sector and ensures that IT solutions meet the needs of the business.
  • Understand the specific challenges and opportunities linked to the regulatory, legal and economic situation across countries and business units.


  • Consulting toward sector senior leadership on IT strategy, tools and solutions.  Recommend solutions assuring fit with  BU direction, strategy and priorities. Where needed, involve area or functional BRM and IT business consultants, as well as external expertise.
  • Develops, proposes, sells and implements innovative solutions to improve business outcomes in support of the business strategies.

Relationship Management:

  • Influence and partner with business leaders (Sr. Director/VP level) to manage the IT portfolio. Close collaboration with other parts of  BU IT, Global Information Services, and other corporate Sector Staff departments, external partners and customers to ensure adequate and timely delivery of agreed services, in line with agreed service levels.
  • Partner and collaborate with key IT staff of other Abbott divisions in order to support cross divisional business initiatives, and explore IT synergies and efficiencies.

Portfolio and Budget Management:

  • In collaboration with business leadership, shapes the portfolio of programs, projects and applications and ensures that the overall sector IT long range plan and budget are aligned.
  • Align the sector portfolios with business unit leadership, identify conflicts and synergies and act upon them accordingly.
  • Negotiates for and secures resources to meet the long range needs of the business.
  • Oversee and control Sector IT budgets, project capital/RCE expenditures and ROI.
  • Oversee and control BRM team budgets, project capital/RCE expenditures.
  • Continually drive opportunities for cost reductions and cost avoidance.

Project Management: 
Participate in business program management based on IT expertise.

Leading People:

  • Responsible for all aspects of people leadership for the BRM team; setting expectations, coaching, counseling, developing, evaluating, feedback, hiring, discipline and separation. Determine necessary skills set. 
  • Confronts and deals with people issues in a constructive and timely manner. Responsible for overall morale of team and promotes cohesive attitude.
  • Establishes staffing/resources plans determining appropriate mix of sourcing opportunities. Responsible for overall organizational effectiveness.


  • Responsible for compliance with applicable Corporate and Divisional policies and procedures.
  • Accountability: Operates with broad goals and objectives; Erroneous decisions would normally result in failure to complete projects critical to major objectives of division.  Has direct impact on capital budget, expenses and major project completion.

Decision Making:
Make strategic decisions that impact sector or site. Shared decision authority for sector IT budget and project activities. Manage initiatives that span multiple virtual teams across the world and cross cultures. 

Minimum Education
Bachelor degree in computer science, business administration or another discipline relevant for the healthcare industry or equivalent experience.

Minimum Experience / Training Required

  • A minimum of 15 years IT experience in large or mid-size multinational healthcare. Broad IT expertise in various disciplines, like systems development, infrastructure, change management, etc. At least 5 years project management experience. Additional experience in setting IT strategy and business IT alignment. 
  • Experience in developing application in and FDA/GXP environment.
  • Product Life Cycle Management and Document Management
  • Strong organizational skills, including program/project  governance and increased levels of staff oversight.
  • Strong  interdisciplinary, intercultural, influence, and networking skills
  • Experience with GxP validation and large scale IT implementations (e.g. ERP, CRM, QSM, etc.)
  • Experience with supplier management
  • Qualifications in project and program management
  • Pharma/Medical Device commercial, development, and manufacturing business process knowledge, as related to IT.
  • Broad knowledge of all technologies used or to be used by the internal customer, their external customers and internal partners.
  • Strong influence and negotiating skills.
  • Experience leading teams - both with direct staff and indirect project teams.
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