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QA Director

Company: Labcorp
Location: Durham
Posted on: September 6, 2021

Job Description:

Job Overview:

Essential Job Duties:

                                                                

Definition and implementation of strategy for the Audit and Inspection Team
Partnering with key stakeholders to oversee and direct compliance activities through risk based methodologies and governance forums.
Responsible for the definition and quality of the audit/inspection program conduct and delivery ( inclusive of all customer audits, internal audits, contracted audits mock inspection and regulatory inspection activities)
Responsible for the appropriate preparedness, conduct and success of Regulatory Inspection outcomes, of both Labcorp Drug Development and Sponsor Inspections.
Messages to RCQA and functional unit leaders the results of risk awareness, trending and signal detections of identified non-compliances and partners to provide insight and direction on the development appropriate improvement plans
Responsible for reporting on key performance and process metrics as well as continuous improvement opportunities.
Strategically evaluating and ensuring Labcorp Drug Development's audit and inspection program to industry standards and regulatory agency trends and identifying areas for future growth and improvement.

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.

Creation and implementation of an inspection preparedness/readiness program

Responsible for educating and knowledge sharing of regulatory trends and associated risk strategies within the business areas.
Ensure functional quality, cost and delivery of tasks according to procedural requirements
Propose and create appropriate organizational metrics/dashboards demonstrating quality and compliance
Develop and effectively communicate functional strategies to external stakeholders
Be the solutions partner to operational leaders driving business strategies, a strong culture of quality and compliance and continuous improvement
Communicate escalation issues to management in a timely manner implementing appropriate functional and business solutions and providing regular update
Negotiate, influence and effectively manage constructive crucial conversations with business partners and external stakeholders
Partner with operational leaders to ensure stakeholder buy-in, resources available and multidisciplinary team in place to drive strategic business process improvement initiatives
Lead successful functional change management initiatives.
Ensure appropriate interpretation of applicable quality regulations/standards and ensure appropriate policies and procedures are revised/created
Develop resource strategies to support the functional needs and ensure recruitment, training etc. is aligned to the strategy
Mentor RC&QA and operational resources, to drive a quality culture
Complete thorough, timely and well documented performance evaluations providing objective feedback to the individual
Ensure Regulatory Compliance and Quality Assurance (RC&QA) management responsibilities, as indicated in applicable controlled documents, are followed
Partner with appropriate internal stakeholders to set and manage the functional budget
Act as the RC&QA Leadership Team's delegate
Represent Covance in external associations/forums/organizations, as an industry SME
Perform other duties, as assigned by management

Education/Qualifications:

A minimum of a Bachelor’s Degree in Life Sciences preferred (or equivalent Life Science experience)

Postgraduate degree (MSC or equivalent) in science or management related discipline, preferable

Experience may be substituted for education

Experience:

16 years in regulatory environment (experience in GXP roles)

Experience & regulatory expertise of industry quality systems/standards

Ability to effectively communicate functional strategy with external parties

Ability to distill critical information

Ability to effectively lead teams through the management of people leaders at multiple sites or geographic locations

Ability to provide consultation, guidance and influence to leaders of multidisciplinary teams to drive strategic business process improvement initiatives

Keywords: Labcorp, Durham , QA Director, Other , Durham, North Carolina

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