An individual in this role demonstrates management skills and leadership abilities to effectively lead a group of QA auditors (typically 10 or more). Regularly deputises for the GLP QA site lead in his/her absence. Ensure that scheduling, auditing, resource allocation and quality improvement activities meet departmental objectives. Provide guidance and support to auditing staff in compliance, interpretation, and quality improvement activities. Leads client or regulatory inspections when required. Supports auditing resource requirements when necessary (may inspect studies, audits, protocols, data and reports in compliance with the protocol and appropriate SOPs, and regulatory requirements. Effectively manages direct expense against project budgets.
Essential Job Duties:
Performs general supervisory duties including full range of recruitment and performance evaluation activities, schedules work, prepares training plans.
Manages a team of GLP/GCP auditors (typically 10 or more).
Defines QA monitoring programmes for their area(s) of responsibility.
Responsible for audit programme execution within their area(s) of responsibility.
Leads the hosting of client or regulatory inspections as required.
Meets with clients as necessary to establish/clarify specific compliance requirements and determine appropriate prevention or resolution of client issues.
Maintains proactive interaction with internal and external clients and subcontractors. Cooperates and maintains good relationships with other groups.
Assigns and schedules study auditing, training presentations and quality improvement activities as appropriate.
Provides leadership, guidance and oversight to the auditing staff. Provides effective guidance to individual staff members for professional and personal development. Identifies and develops candidates for backup Team Leader.
Independently manages independent programs or projects, which aim to improve the quality of the product produced by the QAU.
Assures that staff are trained and proficient in all phases of applicable quality systems operations. Defines and delivers training as required.
Leads PEx initiatives. Proposes and implements process improvements to reduce costs and increase efficiencies.
Monitors budgets and operational costs. Investigates discrepancies in cost recovery.
Uses financial information to assist in their methods/decisions regarding staffing levels, workload and process management. Provides, analyzes, and updates metrics accordingly.
Guides direct reports, internal clients and less experienced peers in GLP/GCP interpretation.
Provides for safety and welfare of staff. Supports/enforces EH&S Policies.
Develops and provides training to operational staff in areas identified by operations or QAU management to improve Covance quality.
Provides expertise in writing or reviewing both operational and QAU SOPs.
Is capable of representing Covance at our client sites either by giving training, performing audits or assisting marketing in its sales activities.
Performs other related duties as assigned.
Bachelor of Science/Arts (BS/BA) degree.
Experience may be substituted for education. For example, a two-year Associate degree plus 2 years applicable experience may be substituted for a BS/BA degree.
Six Sigma Green Belt training preferred.
Ability to perform intermediate/advanced computer skills (e.g., Word, Excel, PowerPoint, Visio, Minitab).
Skilled in planning, budgeting, negotiation and process innovation.
Advanced knowledge and ability to interpret regulations (GLP, GCP) as applicable, as well as a demonstrated understanding of additional quality programs.
Ability to effectively interact with clients and regulatory personnel, and conduct effective training sessions.
Requires strong customer service skills.
Ability to negotiate issues ideas and suggestions.
Skilled in concise writing. Writing should require no external review or edit.