QA Lead Sr. Manager

Fortrea • Durham, NC

7d • Onsite

About The Position

Contributes to the generation of global QA policies on interpretation or application. Provides subject matter GxP expertise and influences the ED/CS/CDS organization by providing guidance and client/authority facing support on specific regulatory topics and Quality Issues. Hosts external audits/inspections (e.g., regulatory inspections, strategic clients). Supports clients in making regulatory (strategic) decisions/issue resolution for study problems. Manages the QA-to-QA relationship with assigned key client(s). Participates in client JOC or governance meetings. Manages the reporting of quality metrics and implementation of necessary corrective actions and/or process improvements via appropriate forum (e.g., Monthly Reports, Site Quality Review, Liaison meetings) for assigned clients. Provides support to Compliance Lead and Sr. management as a contributor or leader of internal functional QA RCQA initiative. Ensures Regulatory Compliance and Quality Assurance (RC and QA) responsibilities, as indicated in applicable controlled documents, are followed. All other duties as needed or assigned.

Requirements

• A minimum of a bachelor’s degree in Life Sciences preferred (or equivalent Life Science experience).
• Experience may be substituted for education.
• 6 years in regulatory environment (experience in GXP roles).
• Ability to manage client responsibilities.
• Report and communicates key quality information to Sr. Managers and QA.
• Effectively lead and communicate critical issues during client meetings.
• Ability to manage difficult conversations and meetings with clients.
• Detailed knowledge of specific regulations/multiple regulations.
• Ability to influence and negotiate.
• Excellent communication, interpersonal, planning, and organizational skills.
• Ability to mentor and lead other colleagues within the group.

Responsibilities

• Contribute to the generation of global QA policies on interpretation or application.
• Provide subject matter GxP expertise and influence the ED/CS/CDS organization by providing guidance and client/authority facing support on specific regulatory topics and Quality Issues.
• Host external audits/inspections (e.g., regulatory inspections, strategic clients).
• Support clients in making regulatory (strategic) decisions/issue resolution for study problems.
• Manage the QA-to-QA relationship with assigned key client(s).
• Participate in client JOC or governance meetings.
• Manage the reporting of quality metrics and implementation of necessary corrective actions and/or process improvements via appropriate forum (e.g., Monthly Reports, Site Quality Review, Liaison meetings) for assigned clients.
• Provide support to Compliance Lead and Sr. management as a contributor or leader of internal functional QA RCQA initiative.
• Ensure Regulatory Compliance and Quality Assurance (RC and QA) responsibilities, as indicated in applicable controlled documents, are followed.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior