Associate Director, Quality Assurance, Customer Support Services

Role Overview

• Provide insight which is exercisable across the large part of the organization.
• Oversee & coordinate assigned QA program in support of customer accounts, functional accounts, audit and inspection program, or QA quality management system at a regional and/or global level.
• Manage the quality assurance oversight of projects, assignments, training and staff.
• Plan, schedule, conduct, report and close audit activities, as assigned.
• Provide Quality Assurance support, guidance and management of Quality Issues, as assigned.
• Assist in the enhancement of Quality Assurance and control policy, and risk identification and mitigation by providing consultation & recommendations to regional and Global QA Management.
• Serve as an author for QA Standard Operating Procedures (SOPs), and act as regional QA representative to the global QA SOP taskforce.
• Host customer audits and participate in review of corrective action plans, as assigned.
• Recommend systems for audit, write systems audit plans, coordinate scheduling, conduct, reporting and closure of internal system audits.
• Serve as the QA Contact for assigned internal/external customers and IQVIA functional areas.
• Oversee documentation, reporting, and closure of compliance issues.
• Support Quality Management in proposal reviews and reporting QA metrics.
• Conduct trend analysis of audit results, provide to internal/external stakeholders as agreed, as assigned.
• Oversee proper coordination of customer-initiated audits and mock regulatory inspections, manage regulatory facility inspections, as assigned.
• Participate in or lead (cross functional) teams for special projects as assigned.
• Promote the concept of quality, the principles of quality management and devise and implement quality improvements.

Requirements

• 10 years experience Quality Assurance experience in pharmaceutical, CRO and GXP Quality Assurance experience.
• GCP QA experience is a big advantage.
• Strong knowledge of pharmaceutical research and development processes and regulatory environments.
• Knowledge of MHRA and FDA regulations is a must.
• Considerable knowledge of quality assurance processes and procedures.
• Excellent problem solving, risk analysis and negotiation skills.
• Possess applicable experience in conducting audits, writing audit reports and analyzing audits.
• Experience in a customer facing role is a big advantage.
• Demonstrated ability to lead and manage multiple responsibilities.
• Ability to coordinate timelines with internal customers and external vendors.
• Ability to manage multiple activities and timelines.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Tech Stack

• Google Cloud Platform

Benefits

• Professional development opportunities
• Work-life balance
• Health and wellness programs