Director, Quality (BRM & PMO)

WHAT YOU’LL DO

The role of the Director, Quality (BRM & PMO) is to guide and lead a Global function that ensures Quality, Compliance and Regulatory across the Abbott Enterprise for IT and in support of Business Relationships by supporting global quality and regulatory, engineering, and physical security organizations.  Must be able to partner with business leaders to develop and refine their IT strategy, navigate the IT organization to successfully deliver technology projects, and support the successful completion of their critical technology-dependent goals.

Develops strategies working with Divisional IT and Software Quality as well as central IT and AQR. Drives standardization of processes, tools and compliance expectations across the enterprise. Keep abreast and others appraised of regulatory quality, compliance, and security issues affecting the IT arena through audit and risk analysis. Lead in the development and enforcement of policies and procedures to support a compliant and consistent IT environment across the Abbott enterprise. Provide technical consultation to Divisional and Corporate counterparts on leveraging and consolidating quality and compliance best practices solutions for competitive advantage. Assess, then train and educate the appropriate business and IT communities on regulatory, compliance and standardize best practice systems when appropriate. In conjunction with internal and external business and technology partners, lead in setting quality, compliance and regulatory strategy and vision to meet business objectives.

Core Job Responsibilities:

Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Develops strategy, processes, governance, and team to support the following key processes for Application Development and Maintenance

• Policy and Procedure Management

• SLC Verification (SQA/VRB)

• Non-Conformance / CAPA Management

• Audit Preparation and Support

• Sox Testing

• Service Provider Audits

• Training Compliance

• Supplier Evaluation

• Performance Review (MRM, etc.)

* Infrastructure QA and Compliance

Works with cross functional executives in Division Quality, AQR, SOX and Internal Audit to align on strategy and ongoing maintenance of Abbott policies and procedures. Establish quality assurance and quality system requirements for IT to meet Federal regulations that apply to computerized systems.

Develop and market software quality assurance and validation strategies to corporation and work with operating divisions and other corporate functions to execute consistent practices. Initiate process improvements to reduce computerized systems development and validation cycle time and expense. Provide expert consulting service in quality assurance activities that support computerized systems. Understands global, regional and country specific requirements in order to support international compliance.

Establish and maintain quality assurance governance models for enterprise systems. Manage department(s) that provides quality unit support for activities in IT ADM. Budget, staffing, and resource management responsibilities.

Manage the integration of compliance initiatives into IT policy, i.e., document management, CAPA, systems quality assurance, training, supplier management, etc.

Additional responsibilities include:

• Project Financial Tracking: Track spending on internally funded projects, ensuring that projected spending matches charged amounts.
• Capacity/Resource Management: Execute quarterly “pre-demand” process, yearly demand planning activities in coordination with the BTS resource capacity team
• Demand Management Council: Manage the intake process, stakeholder feedback, and quarterly demand review with senior leadership.
• Portfolio Management & Delivery Management: Facilitate approvals during the project intake process, project estimate reviews, delivery activities and issue escalation associated with project requests and delivery.
• Business Governance: Conduct regular strategic partnership meetings with business leaders, maintain Business Relationship Plans and a robust engagement strategy.
• Customer Focus: Serve as the primary point of contact to the business for BTS enterprise initiatives, facilitate communications with business customers, and gather input on customer feedback.

Position Accountability & Scope:

This person reports to the Senior Director IT Quality, Regulatory and Compliance. Primary relationships are executives within Abbott IT, Abbott AQR, Abbott Internal Audit, and the Divisional Quality Departments. The scope includes driving compliance accountability for the full Abbott IT organization across all divisions and corporate IT for quality and compliance. This position will lead all teams across IT that will be accountable for software validation, quality assurance, quality engineering, and regulatory compliance process and operational improvements.

Supervisory Responsibilities:

Up to 12 direct reports

Minimum Education:

BS Computer Science, Engineering, Medical, Business, Quality or related field required.

Minimum Experience/Training Required:

10+ years of experience throughout the following environments:

Software Quality/Compliance management in a regulated healthcare environment

Overall management experience Software Development and Validation

Regulated Software Development and Validation Industry Environments

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

• Training and career development, with onboarding programs for new employees and tuition assistance

• Financial security through competitive compensation, incentives and retirement plans

• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs

• Paid time off

• 401(k) retirement savings with a generous company match

• The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is $136,000.00 – $272,000.00. In specific locations, the pay range may vary from the range posted.

• compliance management
• delivery management
• demand management
• resource management
• supplier management
• portfolio management
• it strategy
• procedure management
• capa management
• demand planning
• global
• regulatory compliance
• internal audit
• financial tracking
• regulatory strategy
• risk analysis
• quality assurance
• document management
• quality engineering
• software quality
• software quality assurance
• application development
• aqr
• software validation