Covance Quality Control Mgr, Proj Mgt in Philadelphia, Pennsylvania
HQ CQM: CORE Accountabilities and Responsibilities
Quality Management subject matter expert who provides real-time, proactive advice and guidance on procedures and issues relating to Quality, Compliance and Global Processes related to clinical development program management, clinical trial activities and vendor oversight.
Ensures creation of the Quality Plan and performs quality data review for Clinical Development Programs that are prioritized according to the Book of Business and in agreement with CSSM Heads and Clinical Therapeutic Area Heads.
Collaborates with HQ CQM Lead to facilitate appropriate quality issue escalation and resolution in accordance with all applicable change management processes.
Audit and Inspection Support:
Develops and maintains Story Boards for Clinical Development Programs and pivotal clinical trials to implement a risk based mitigation approach in view of inspection readiness.
Supports the Global Inspections Management group, as part of the preparation support teams for trial-related sponsor and/or site related inspections.
Supports the development of responses to audits and inspections and ensures appropriate CAPA implementation.
Ensures that all actions and commitments are implemented in a timely manner.
Escalates issues to HQ CQM Lead from discussions/meetings with other functional areas (i.e. QCI, MRL QA, & GCTO).
Quality Signal Detection:
Supports Therapeutic Area staff with in depth knowledge of current audit and inspection trends across and within programs.
Develops, implements and analyzes TA specific holistic quality plans (risk based approach) to detect quality signals before they are identified as audit observations and/or inspection findings.
Trends known quality issues, coordinates global and regional investigations.
Develops and manages targeted QCVs, including the analysis and development of appropriate action plans in agreement with defined thresholds.
Quality Signal Analysis:
Provides processes, systems and knowledge needed to proactively disseminate known and potential quality issues from local/regional to global perspective.
Supports QCI Management and Therapeutic Area staff by providing an ongoing consolidation and current overview of known issues.
Quality Issue Prevention:
Deploys and maintains global Quality Information management tools (e.g. Story Boards) to track and trend issues as well as manage them through their implementation life-cycle.
Implements a Quality by Design approach from initial Protocol through Clinical Study Report.
Provides input and approves trial specific monitoring plans.
Supports qualification and quality management of global vendors.
Education : Bachelor Degree or equivalent in relevant health care area
A minimum of 5 years of relevant experience in clinical research including direct field monitoring experience or management/oversight of such individuals, with a demonstrated record of accomplishments.
Deep knowledge and understanding of Clinical Development Programs, Clinical Trial processes as well as quality management and control tools is required.
Experience in Therapeutic Area, specifically related to design of trials and therapeutic area specific clinical assessments and medical practice.
Direct experience in quality management, GCP Auditing and GCP Inspections.
Experience delivering effective CAPA management solutions.
Superior oral and written communication skills in an international environment.
Excellent project management and organizational skills.
Excellent teamwork and leadership skills, including conflict resolution expertise and discretion.
Ability to lead cross-functional teams of business professionals.
Ability to analyze, interpret, and solve complex problems.
Ability to think strategically and objectively and with creativity and innovation.
Ability to proficiently interact with all levels of management and exert influence to achieve results.
Job Number 2018-25848
Job Category Clinical Data Management
Position Type Full-Time
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