Quintiles is the world’s largest provider of biopharmaceutical development and commercial outsourcing services. We bring a fully integrated approach to build biopharma and life sciences solutions – from pipeline through portfolio to population health™. A career with Quintiles connects you to great opportunity to achieve professional success and impact healthcare around the world.
This role is a strategic quality management position within the Global Clinical Operations unit, focused on development, deployment, and optimization of our processes and systems to achieve optimum quality performance, output, and standards across Global Clinical Operations. This leader will have governance responsibilities and oversight of the operational processes deployed at Quintiles, ensuring that they are effective and efficient.
- This strategic QM expert will have leadership responsibilities for driving transformation across Clinical Operations. The VP, Process Management will create and launch the Process Owners for Clinical Operations, including the Process Owner Network that will include Process Owners from cross-functional units in DSSR, GDN, Asia, and RWLPR. This role will be responsible for process team management and leadership.
- Design, develop, implement and provide strategic oversight of comprehensive operational quality controls and processes for Global Clinical Operations to ensure that all projects and processes meet applicable standards, customer quality requirements, and regulatory requirements
- Align and integrate existing management processes to strategize for competitive advantage for Quintiles and its customers within the marketplace
- Prioritize quality initiatives by identifying area of greatest impact to the organization
- Model and forecast fiscal implications of potential strategies, provide technical support and use strategic plan to guide development of annual operating budgets and spend on quality initiatives
- Partner with senior leaders to implement process improvements and solutions
- Initiate quality deep dives to identify trends, key root causes affecting quality performance indicators and define and drive quality improvement initiatives
- Ensure alignment between quality management and the business unit and enterprise strategy and business objectives
- Responsible to ensure a strong partnership with Global QA and alignment of audits to our risk areas
- Provide consultation related to change management and communications
- Provide guidance on innovation and trends for improving quality management and standards
All responsibilities are essential job functions unless noted as nonessential (N).
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Proven ability to lead a global high performing team while capitalizing on the talents and skills of the team
- Deep understanding of business process engineering, how to measure processes and impact of changes, and appropriate feedback loops for continual improvement to quality, efficiency, productivity, customer satisfaction, and cost. Ability to make recommendations for process improvement and execute actions until desired outcome is achieved.
- Understanding of cost of quality and implications of changing process on customer satisfaction, efficiency, productivity, quality, and enterprise finances.
- Ability to link strategic vision and insights to operational delivery to execute executive agenda. MBA or experience with strategic and/or financial planning.
- Fundamental understanding of quality philosophies, principles, systems, analyses methods, tools, standards, reporting, etc. and effective application of these principles into strategies as in a complex and dynamic environment.
- Experience in developing and/or implementing a quality management plan (quality metrics, checklists, and process improvement plan). ASQ CMQE or CQE certification. TQM experience and/or lean six sigma certification.
- Excellent analytical/problem solving skills with ability to apply critical thinking to customize solutions for quality issues of all kinds.
- Able to manage disputes among stakeholders and recommend the best course of action for peaceful resolution that is in the best interest of the company.
- Highly collaborative and adept at building key professional relationships. Strong interpersonal skills and dedication to customer service. Excellent matrix and cultural team leadership skills.
- Experience with corporate change management efforts. Ability to communicate effectively both orally and in writing and cater communication style and message delivery based on audience.
- Effective organization, communication, and team orientation skills
- Strong software and computer skills, including MS Office applications.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Degree in Life Science, Business Management or related field and a minimum of 10 years in the pharmaceutical, CRO, or related industry, experience to include clinical operations, CRA, and /or alternative operational functional (e.g. business development, data management, project management, laboratory, pre-clinical); or equivalent combination of education, training and experience.
Extensive knowledge of the pharmaceutical research and development process and the regulatory environment
Understanding and an appreciation of working with different cultures