QA Associate Director, Customer Engagement - REMOTE

Job Summary:

Serves as the primary RC&QA solutions partner for sponsors by liasing with internal stakeholders to mitigate risk, provide regulatory and compliance consultation. Facilitate investigations into quality issues and CAPA development, as well as analyzing data trends to proactively identify improvement opportunities. Represent RC&QA during sponsor audits and regulatory inspections.

Essential Job Duties:• Maintains currency with legislation, regulations, guidelines, Sponsor requirements and inspection trends and informs internal stakeholders• Partners with the audit and inspection team on modifying risk based audits based on current trends• Provides consultation on regulatory and compliance matters ensuring appropriate risk mitigation is completed• Drive continuous improvement initiatives based on quality and compliance risks• Represent RC&QA while leading sponsor audits and regulatory inspections either internally, or participating in the same at sponsor organizations• Ensure direct line managers assign appropriately trained resources, for all locations of responsibility, in order to make sure that tasks are completed according to procedural requirements• Through direct line managers ensure consistent functional implementation, use and review of SOPs• Effectively communicate functional strategies to internal stakeholders• Publish executive summaries of functional and internal stakeholder metrics/dashboards including risk mitigation, when needed• Communicate escalation issues to management in a timely manner implementing appropriate functional solutions and providing regular updates• Negotiate and effectively manage constructive crucial conversations with external stakeholders• Ensure stakeholder buy-in, resources available and multidisciplinary team in place to drive strategic functional process improvement initiatives• Act as the RC&QA solutions partner for operations to drive a strong culture of quality and compliance• Interpret applicable quality regulations/standards and ensure appropriate policies and procedures are revised/created• Recruit, train, coach and develop leaders based on their development or business needs• 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• Manage the functional budget, for the multiple sites or geographic locations of responsibility• Act as the RC&QA Leadership Team's delegate• Represent Labcorp in external associations/forums/organizations, as an industry SME• Perform other duties, as assigned by management

Minimum Experience Required:• 14 years in regulatory environment (experience MUST be in Clinical (GCP) roles)• Experience & regulatory expertise of clinical industry quality systems/standards• Ability to resource and lead a multidisciplinary team to drive strategic functional process improvement initiatives• Ability to communicate and negotiate with external parties effectively• Ability to distill critical information• Ability to effectively lead teams through the management of people leaders at multiple sites or geographic locations

Education/Qualifications/Certifications and Licenses

Recommended:• 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

Labcorp is proud to be an Equal Opportunity Employer:

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