This position is a leadership role highly visible within the organization required to work with all levels of management internal to Covance (up to and including Executive Leadership Team). This position will oversee and drive the culture of quality, compliance, prevention of quality issues and partner with the organization on improvement initiatives.
This position has responsibility for strategic direction, delivery and oversight of the Internal Process Compliance function. This position and department will be aligned as partners to the functional areas of the CDCS business to ensure appropriate quality/compliance oversight and solution partnering. Driving compliance excellence within the organization through execution of key activities, improvement methodologies and governance forums. Of importance are the requirements to lead, strategize, partner and influence across various functions and locations.
Provides regulatory compliance and quality assurance advice, guidance and support to internal CDCS teams and functions and collaborating with other internal stakeholders (e.g; Legal) for proactive interactions and quality management
Key areas of responsibility include but are not limited to the following:
Definition and implementation of strategy for the Process Lead team
Creating and implementing a compliance program for functional areas in CDCS
Partnering with key stakeholders to oversee and direct compliance activities through risk based methodologies and governance forums.
Leading quality management reviews and interfacing with senior leaders to drive a process improvements and creating a culture of quality. Messages to RCQA and functional unit leaders the results of trending and signal detections of identified non-compliances and partners to provide insight and direction on the development appropriate improvement plans
Engaging and driving quality management and inspection readiness within the organization.
Developing a high performing team and all applicable resource management responsibilities inclusive of talent development.
Is an active member of the CDCS RCQA leadership teamEducation/Qualifications: Minimum Required:
- University/college degree, BA/BS (life science preferred) or equivalent experience
- Masters or other advanced degree (e.g. postgraduate qualification in Quality Assurance) or equivalent experience a plus
12-15 years experience in a regulated environment (e.g. GCP) in roles of a related discipline (e.g.
Quality Assurance, Regulatory, Operations, Project Management), with 10 years supervisory experience or equivalent experience
- Proven ability to manage managers and business leaders in a global clinical operations setting
- Proven ability to understand, analyze and communicate the impact of global regulatory issues affecting the drug development process
- Thorough knowledge of global clinical development processes, standards and budgeting
- Knowledge of the drug development process from the perspective of a contract research organization
- Experience in quality improvement methodologies such as FMEA, Six Sigma or other similar BOK
- Demonstrated ability to lead and influence/guide at all levels
- Demonstrated ability to successfully interact with Executive leadership
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