Associate Director, IT - Infosario Delivery Excellence & Risk Assurance (Quality Consultant)
Quintiles Transnational Corporation
Why Quintiles? A career at Quintiles puts you at the corporate center of the leading worldwide pharmaceutical services organization. We have been named to the 2008, 2009, 2011, 2012 and 2013 lists of Computerworld's "100 Best Places to Work in IT". If you want to work for a global, fast-paced organization dedicated to improving the development and marketing of medicines, Quintiles is the place for you. We are seeking dynamic, highly motivated and results focused individuals that take an innovative and consultative approach to driving and achieving success. Apply now for our Associate Director, IT – Infosario Delivery Excellence & Assurance (Quality Consultant) position located in our Research Triangle Park / Durham, NC office.
PURPOSE:
The Associate Director, IT (Quality Consultant) in the Infosario Delivery Excellence & Assurance (IDEA) organization leads the design, development, organization, and delivery of quality programs to ensure that IT products meet customer expectations and to assure compliance with global regulatory requirements and internal procedures. The ITQM is the primary point of contact for quality programs on or more IT products.
RESPONSIBILITIES:
· Participate in the creation of the IDEA organization’s strategy, goals and objectives and develops plans and programs to support the strategy.
· Develop, implement, and maintain programs and reports utilizing tools (tracking software, trending metrics, databases) to perform quality assessments and analyses, identify procedural and systematic delivery and compliance risks,. Proactively communicates risk based recommendations that complement the needs and direction of stakeholders.
· Track the effectiveness of corrective & preventative actions (CAPA) developed by product teams and ensure the adequate and timely implementation of CAPA commitments.
· Lead quality program activities for assigned products – including but not limited to product quality reviews, risk reviews, SDLC/process consulting and audit support.
· Oversee the tracking of quality programs and releases/projects with respect to milestones, deliverables, and quality of demonstrated results.
· Provide quality related expertise, guidance, and support through participation in cross-functional, multidisciplinary teams. Ensure optimal relationships with key internal stakeholder groups, vendors, and business partners to enable successful process improvement and to maximize compliance.
· Perform product quality review assessments of applicable controlled documentation, delivery practices, key performance indicators & trends by applying solid knowledge of corporate SOPs, departmental controlled documentation and processes, and global regulations.
· Partner with appropriate groups outside IT such as Global Quality Assurance, Systems Compliance Office etc., to ensure inspection readiness, and act as the primary point of contact for requests relating to customer audits and regulatory inspections.
· Conduct regular meetings and communication with product managers, product quality owners and delivery leads.
· Lead the development, implementation and maintenance of quality program related controlled documentation. Lead CAPA planning and process improvements, and facilitate change management.
· Proactively research and communicate industry and global quality trends and initiatives to ensure compliance and to identify continuous process improvement opportunities.
· Support and lead functional initiatives and participate in Development initiatives, as assigned.
· Demonstrates strong organizational, planning, and project management skills.
· Demonstrates the ability to manage multiple priorities in a fast paced, entrepreneurial and changing environment.
· Demonstrates analytical problem solving skills with a broad perspective, and effectively formulates strategies, tactics and action plans to achieve results, follows good decision making principles.
· Demonstrates initiative, a self starter and able to work independently.
· Excellent interpersonal, and oral and written communication skills. Skilled in presenting and tailoring presentations to audience.
· Communicates with credibility and confidence. Displays a high level of commitment and adaptability to unfamiliar situations.
· Generates enthusiasm and drive for commitment to excellence.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:
· Strong working knowledge of software development/ delivery methodologies and regulatory expectations in ICH-Q9, SOX, 21CFR-Part 11 will be a distinct advantage for this role.
· Strong analytical skills. Skilled in computer applications and software programs.
· Experience in blogging and/or presenting at leading conferences on topics related to software quality, software engineering best practices etc.
· Willing to travel (domestic and international) 5 - 10%.
EEO Minorities/Female/Protected Veterans/Disabled
MINIMUM REQUIRED EDUCATION AND EXPERIENCE:
· Bachelor’s Degree in Computer Science or related field; with 10 years IT experience including previous management experience or equivalent combination of education, training and experience
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