Covance Senior Director, Compliance Management in Princeton, New Jersey

Job Overview

The Senior Director, Compliance Management position can be home based or office based anywhere within the United States.

The Senior Director, Compliance Management is a key leadership position with responsibility for strategic direction and oversight of the compliance management function. Key areas of responsibility include oversight of investigations and CAPAs for escalated quality issues, entry and trending of quality events using a centralized Quality Management System, and QA interface with Covance senior leaders and sponsor/client QA groups.

This position is responsible for oversight of QA Leads and operations supporting audits by clients and supporting regulatory inspections at investigator sites and Covance as well as client/sponsor interactions for quality assurance governance and oversight.

This position requires a leadership role working with all levels of management internal to Covance (up to and including Executive Leadership Team), to drive the culture of quality, customer interactions for QA and prevention of quality issues.

Additionally, this role has responsibility for routinely communicating and negotiating with Clients externally (QA and governance representation) regarding quality assurance activities, strategies, metrics and oversight.

Essential Job Duties:

–Strategic direction and oversight to the compliance management function in CQA&C, ensuring the sound investigation, root cause analysis, CAPA and effectiveness check development for quality events identified during the conduct of Covance managed clinical trials.

–Ensure the quality of QA-QA interactions with Clients and Covance staff in support of issue escalation and notification, corrective and preventive actions to client-specific issues and quality governance

–Strategic direction and support of trending and identification of signals from all non-compliances.

-Communicates and discusses with functional unit leaders the results of trending and signal detections of identified non-compliances and develops appropriate Continuous Improvement Plans

–Strategic direction and support of client audits and regulatory inspections, particularly with regard to CAPAs, trends and continuous improvement activities.

–Providing 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 client interactions and quality management

–Ensuring continual evolution and advancement of standards and requirements for compliance management processes, including operational oversight and continuous improvement for proactive quality management

–Serve as key point of QA leadership contact in developing quality assurance strategies with Clients and CDS operations; serve as QA representation to operational and/or quality governance as appropriate

–Partner with QA Leadership and QA Governance Leads to ensure alignment and continuity across the Quality Management System and identification of continual improvement opportunities

–Talent management, colleague performance management, development and engagement

Education/Qualifications

Minimum Required:

-University/college degree, BA/BS (life science preferred) or equivalent experience

Preferred:

-Masters or other advanced degree (e.g. postgraduate qualification in Quality Assurance) or equivalent experience a plus

Experience

Minimum Required:

-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

-15 years experience in pharmaceutical/CRO industries

-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

Job Number 2018-26061

Job Category Quality Assurance

Position Type Full-Time

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