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Quality Assurance Director, must have BioA experience

Job Overview
Drive the quality assurance programs at a regional and/or global level. Provide direction in support of customer / functional accounts, audit and inspection programs, and the QA quality management systems. Provide insights, analyses and support in the promotion and assessment of compliance with regulations, guidelines, and operating procedures within the Region or Globally Assigned.

Essential Functions
• Establish and maintain strong working relationships with internal and/or external customer team leads and counterparts, as assigned
• Provide actionable insights to customer counterparts, QA Leadership and Senior Management
• Drive quality improvements and efficiencies along with risk mitigation based on QA data analyses, operational performance data, knowledge of process management, changing regulations and customer expectations
• Provide consultation and support concerning compliance with regulations and appropriate controls, quality measures and risk assessment and mitigation in the development of improved or new service offerings across the business
• Lead and project manage internal QA quality improvement initiatives
• Plan, schedule, conduct, report and close audit activities
• Assist in enhancement and establishment of quality assurance and control policy and risk identification and mitigation by providing consultation and recommendations to regional and Global QA Leadership
• Serve as author for QA Standard Operating Procedures (SOPs)
• Serve as QA representative on Standard Operating Procedures (SOP) Taskforce(s) for other IQVIA functional areas as assigned
• Participate in or lead teams for special projects as assigned. Teams may be cross functional
• Provide guidance, interpretation, support, training, and key input to development groups for consultation and interpretation of regulations, guidelines, corporate standards, and policies
• Host customer audits and/or regulatory inspections participate in review of corrective action plans and effectiveness checks.
• Recommend process and systems for audit, write systems audit plans and oversee the delivery of these audits, review the Corrective and preventive actions (CAPAs) and ensure approrpaite follow up
• Oversee documentation, reporting, and closure of significant compliance issues
• Support QA Management Leadershipin proposal reviews and reporting QA metrics and insights
• Act as primary back-up for QA Leadership
• Conduct trend analysis of audit results and provide QA management with initial root cause analysis
• May present trend analysis results and QA metrics and insights to IQVIA upper management
• Ensure proper coordination of customer-initiated audits and mock regulatory inspections, and manage regulatory facility inspections
• Manage staff in accordance with organization's policies and applicable regulations. Responsibilities include planning, assigning, and directing work, appraising performance and guiding professional development, rewarding and disciplining employees, addressing employee relations issues and resolving problems. Approve actions on human resources matters.

• Bachelor's Degree Req
• 12 years Quality Assurance experience in pharmaceutical, technical, or related area, including GCP Quality Assurance experience. 5 years of management experience. Equivalent combination of education, training and experience.
• Knowledge of word-processing, spreadsheet, and database applications.
• Extensive knowledge of pharmaceutical research and development processes and regulatory environments.
• Considerable knowledge of quality assurance processes and procedures.
• Strong interpersonal skills.
• Excellent problem solving, risk analysis and negotiation skills.
• Effective organization, communication, and team orientation skills.
• Senior Management experience in Quality Assurance.
• Ability to influence and guide others at all levels of management.
• Demonstrated ability to lead and manage multiple responsibilities.
• Ability to manage costs effectively through appropriate resource allocation.
• Ability to articulate and define departmental needs and processes.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Q² Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions.

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities.

As the COVID-19 virus continues to evolve, Q² Solutions' ability to operate and provide certain services to customers and partners necessitates Q² Solutions and its employees meet specific requirements regarding vaccination status.

Quality Assurance Director, must have BioA experience

Durham, NC
Full Time

Published on 08/06/2022

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