Job Description

Senior Director, Quality Assurance



Primary Location: Durham, North Carolina, United States Full time R1181699 Date Posted: 02/02/2021

Job description

Summary:

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.

Purpose:

Accountable for driving the Quality Assurance delivery program within assigned region. Oversee support of customer / functional accounts, audit and inspection programs, business analytics, and QA quality management systems. 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. Lead the global Customer Strategy Team, one of the global QA pillars.

Summary of Responsibilities:

* Ensures appropriate and ongoing functional and program-level oversight of QI and CAPA.
* Collaboration with QA BA&DS team to aggressively utilize CAPA metrics to develop impactful interventions to improve the efficiency, impact and scalability of CAPAs
* Collaborates with quality partners to ensure that an appropriate link between preventive actions and the management of risk.
* Serves as a strategic partner to internal and external business partners in driving innovative approaches for issue management within clinical development and credible thought leadership regarding CAPA processes.
* Ensures appropriate resources to execute the programs compliantly, effectively and efficiently.
* Develops internal talent through cost-efficient educational and developmental activities that enhances the succession-planning process.
* Manages staff performance, utilization, efficiency and revenue recognition
* Performs other related duties as assigned.
* Oversee direction of Quality Assurance Program, as assigned
* Ensure quality assurance organization and operating procedures are in place to support assigned program(s) 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 as assigned. 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 organizations 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
* Performs other duties as needed.

Required Knowledge, Skills and abilities:

* Strong negotiation and influencing skills; demonstrated ability to work constructively and effectively at all levels across functions as well as with external customers.
* Strong project management skills, strategic mindset and demonstrated business acumen
* Demonstrated expertise in implementing successful process and continuous improvement efforts, yielding increased effectiveness and efficiency
* Strong knowledge of the principles for a GCP Quality Management System, ICH Guidelines, FDA regulations, the EU Clinical Trial Regulation, EU Directives, MHRA Statutory Instruments, EMA PV requirements and other relevant laws, regulations, and guidance.
* Superb and polished ability to consistently present information in a clear, compelling, and understandable format, tailoring presentations to the context and audience.
* Highly professional and unflappable demeanor to effectively interact with senior internal leaders and external stakeholders
* Demonstrated experience leading and successfully and timely delivering on implementation of cross-functional initiatives and programs with senior executive leadership visibility.
* Demonstrated experience designing and implementing effective Quality Management Systems in a clinical trial and/or pharmacovigilance setting, with a focus on issue management.
* Minimum 5 years of experience in clinical development or pharmacovigilance in the pharmaceutical, biotech, or other regulated industry.
* Prior line management 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.
* Ability to influence and guide others.
* Ability to establish and maintain effective working relationships with coworkers, managers and clients

Required Education and Experience:

* Bachelors/primary degree
* 10-15 years experience in pharmaceutical, technical, quality assurance, or related area, including 6 years of management experience. Equivalent combination of education, training and experience.

LI-Remote

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 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIAs Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.