Senior QA Professional

Quality Assurance Manager

As a Quality Assurance Manager, you will be responsible for overseeing and coordinating assigned QA programs in support of customer accounts, functional accounts, audit and inspection programs, or QA quality management systems at a regional and/or global level.

You will provide support to management with insights, analyses, and support in the assessment and promotion of compliance with regulations, guidelines, and operating procedures, risk identification, and mitigation, quality, process, productivity/efficiency improvement initiatives.

Your responsibilities will include managing the quality assurance oversight of projects, assignments, training, and staff.

Essential Functions

• \
• Provide guidance, interpretation, support, training, and key input to development groups for consultation and interpretation of regulations, guidelines, corporate standards, and policies.\
• Oversee and participate in the documentation, reporting, and closure of compliance issues.\
• Organize and deliver training to other departments concerning the activities of Quality services, results of activities, quality initiatives, GXP etc.\
• Ensure the follow-up of major and critical audit findings to ensure that appropriate actions have been taken and have adequately resolved the issues identified.\
• Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.\
• Serve as author of Quality Assurance Standard Operating Procedures (SOPs) as assigned.\
• Advise Quality Assurance management on system audit needs.\
• Ensure the Quality Assurance database is maintained and up-to-date to reflect the status of audits being scheduled, auditor assignment, and audit reporting and/or follow-up status.\
• Host customer audits, mock regulatory inspections, and regulatory facility inspections as needed.\
• Develop and implement strategies to improve quality, process, and productivity efficiency across the organization.\
• Collaborate with cross-functional teams to identify areas for process improvement and implement changes.\
• Analyze data to identify trends and areas for improvement and develop recommendations for management.\
• Stay up-to-date with changing regulations and guidelines and ensure compliance across the organization.\
• Lead and manage a team of Quality Assurance professionals to achieve business objectives.\
• Communicate effectively with stakeholders to ensure clear understanding of quality expectations.\
• Identify and mitigate risks associated with quality and regulatory compliance.\
• Manage and maintain accurate records and reports related to quality and compliance.\
• Conduct root cause analysis to identify and resolve quality and compliance issues.\
• Participate in the development and implementation of new processes and procedures to improve quality and compliance.\
• Foster a culture of quality and compliance within the organization.\
• Stay current with industry developments and emerging trends.\
• Make decisions based on data-driven insights and business objectives.\
• Demonstrate leadership skills to inspire and motivate team members.\
• Build strong relationships with internal stakeholders to drive business outcomes.\
• Communicate effectively with external partners and vendors to ensure compliance and quality.\
• Lead by example and demonstrate a commitment to quality and compliance.\
• Support and promote a culture of transparency, accountability, and integrity within the organization.\
• Identify opportunities for growth and development within the organization.\
• Contribute to the development of policies and procedures to ensure compliance and quality.\
• Collaborate with the IT department to implement technology solutions to improve quality and compliance.\
• Develop and implement training programs to educate employees on quality and compliance.\
• Establish and maintain effective working relationships with coworkers, managers, and clients.\
• Ability to work independently with initiative and take ownership of projects.\
• Strong organizational and time management skills.\
• Excellent communication, interpersonal, and problem-solving skills.\
• Strong analytical and decision-making skills.\
• Demonstrated ability to lead and manage high-performing teams.\
• Proven track record of driving business outcomes through strategic planning and execution.\
• Experience in pharmaceutical, technical, or related area preferred.\
• 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.\
• Ability to travel up to 30% of the time.\
• Bachelor's degree preferred.\
• Equivalent combination of education, training, and experience considered.\

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries.

We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.