Senior Director, QA (Clinical Research)
- Experience Level
- Senior Management
The IQVIA QA team is a dynamic, talented, and experienced global team that owns the global quality management system for the largest human data science company in the world. The QA function is responsible for driving compliance in a highly regulated industry through audits, functional support, issue & CAPA management, regulatory consultancy, management of data analytics and customer relationship interactions. These services ensure our clinical research activities are of the highest quality. We proactively support our business partners and help to drive innovation. Continuous improvement is a core capability and we value strategic thinking, creativity, and operational excellence. We seek highly motivated people who truly want to make a difference in the life sciences industry and are looking for opportunities to impact the business and be part of the solution. At IQVIA, we support our colleagues with a focus on succession planning, career progression and continuous learning.
This position will be driving the Quality Assurance delivery program globally for Inspection Readiness and Inspection Management. This role sits on the QA Leadership team and will play an instrumental role in support of the quality organization’s strategic goals, with respect to inspection preparedness and outcomes. It is responsible for ensuring teams within the region have clear focus and understanding of QA strategy and that services are executed and delivered to the highest standards and within budget.
• Oversee direction of the assigned Quality Assurance Program
Ensure quality assurance organization and operating procedures are in place to support assigned programs of work
• Oversee QA delivery by ensuring staff have a clear focus and understanding of QA strategy and that services are executed and delivered with effective and efficient processes to follow
• Ensure there is regular assessment and oversight of performance and that services are executed to the highest standards of compliance with regulations, standard operating procedures and principles of process management
• Ensure there is a continuous improvement program to optimize processes
• Ensure the program of work is delivered within budget, time frame and resourcing constraints
• Identify risks to delivery of the program of work and manage the mitigations
• Identify opportunities for improvements, efficiencies, and elimination of redundant activities, ensuring the program of work continues to represent excellent value to the business in return on investment
• Support the Global Head of QA and collaborate with peers in collective responsibility for the delivery of all QA services
• Undertake other essential and critical operational duties in line with department need, e.g., Host customer audits and /or regulatory inspections, and oversight preparations of prepare corrective action plans and effectiveness checks
• Participate in or lead teams for special projects. Teams may be cross functional
• Ensure industry standards training of department staff for regulatory inspections
• Supervise consultation, guidance, tracking, and metrics system
• Interface with senior management to discuss quality and compliance issues
• Interface with business development and operations to identify business opportunities
• Recommend staff management actions in accordance with organization’s policies and applicable laws. •Recommendations include training, coaching, and mentoring employees, planning, assigning, and directing work, appraising performance and guiding professional development, rewarding and disciplining employees, addressing employee relations issues and resolving problems
Required Knowledge, Skills, and abilities:
- Knowledge of word-processing, spreadsheet, and database applications.
- Strong knowledge of pharmaceutical research and development processes and regulatory environments; clinical and post-marketing pharmacovigilance experience is essential.
- Previous experience of GVP regulatory inspections.
- Considerable knowledge of quality assurance processes and procedures.
- Strong interpersonal skills and the ability to positively influence and guide others.
- Excellent problem solving, risk analysis and negotiation skills.
- Effective organization, communication, and team orientation and leadership skills
- Possess applicable experience in conducting audits, writing audit reports, and analyzing audits.
- Ability to coordinate timelines with internal customers and external vendors on a global scale.
- Ability to work globally and manage multiple activities and timelines.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
Required Education and Experience:
- Bachelor's Degree Required.
- 12-15 years of Quality Assurance experience in pharmaceutical, or related area including GVP Quality Assurance experience. Equivalent combination of education, training, and experience.
- Demonstrated ability to lead and manage multiple responsibilities.
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.