QA Associate Director - Hosting Regulatory Inspections
Company: IQVIA LLC
Location: Durham
Posted on: May 26, 2023
Job Description:
QA Associate Director - Hosting Regulatory Inspections page is
loaded QA Associate Director - Hosting Regulatory Inspections Apply
locations Durham, North Carolina, United States of America Topeka,
KS Aurora, Illinois, United States Detroit, MI Joliet, IL time type
Full time posted on Posted 4 Days Ago job requisition id R1349192
Remote Opportunity - USA or CanadaPurpose:
This QA Associate Director role is with the Client Audits &
Regulatory Inspections (CARI) Team, part of Enterprise Quality
Assurance. This QA Associate Director will support mainly the
Hosting of Regulatory Inspections at IQVIA, specifically PV
Inspections, as well as Sponsor and Customer Audits at the Sponsor.
This person may also support Customer Audits at IQVIA if required.
This will also be a Line Manager position. Will provide insight,
which is exercisable across the large part of the organization, or
by managing a team of managers by influencing outcomes. 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. Provide
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. Act as line
manager for one or more QA staff and oversee development and
departmental deliverables. Manage the quality assurance oversight
of projects, assignments, training and staff.Responsibilities:
- Plan, schedule, conduct, report and close audit activities, as
assigned, in any of the countries involved with IQVIA contracts to
assess compliance with applicable regulations/guidelines, customer
requirements, Standard Operating Procedures ( SOPs) and project
specific guidelines/instructions.
- Host customer audits and participate in review of corrective
action plans, as assigned
- Provide Quality Assurance support, guidance and management of
Quality Issues, 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 proper coordination of customer-initiated audits and
mock regulatory inspections, manage regulatory facility
inspections, as assigned
- Oversee documentation, reporting, and closure of compliance
issues
- 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
- Provide guidance, interpretation, support, training, and key
input to development groups for consultation and interpretation of
regulations, guidelines, corporate standards, and policies
- 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
- 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
- Manage staff, including planning, assigning, & directing work,
appraising performance, guiding professional development, rewarding
and disciplining employees, addressing employee relations issues &
resolving problems. Approve actions on human resources
mattersRequired Education and Experience:
- Bachelor's Degree in Scientific or Healthcare related
field
- 10 years of Clinical Quality Assurance experience from the CRO,
Pharmaceutical, Biopharmaceutical, etc. industry , with a focus in
development and Post-Marketing (Mainly Pharmacovigilance).
- 3+ years of Line Management experience within Quality
Assurance
- Or equivalent combination of education, training and
experience
- Demonstrated experience Hosting Regulatory Inspections,
specifically PV/Pharmacovigilance Inspections, and Sponsor/Customer
Audits
- Thorough understanding of requirements of major regulatory
agencies (FDA, EMA, PMDA, etc.) and demonstrated experience
interpreting and applying relevant regulations, laws and
guidance.
- Practical experience applying proactive quality approaches for
clinical trials. Required Knowledge and Skills:
- Considerable knowledge of quality assurance processes and
procedures.
- Strong knowledge of pharmaceutical research and development
processes and regulatory environments.
- Effective organization, communication, and team orientation and
leadership skills.
- Knowledge of word-processing, spreadsheet, and database
applications.
- Ability to influence and guide others.
- Ability to manage costs effectively through appropriate
resource allocation.
- Ability to establish and maintain effective working
relationships with coworkers, managers and clients.
- Strong interpersonal skills.
- Excellent problem solving, risk analysis and negotiation
skills.Travel:
- Up to around 30% ; Hosting 1-4 Inspections/Audits per month;
Virtual and On-Site Summary: The IQVIA Quality Assurance 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, hosting
customer audit and regulatory inspections, 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. #LI-Remote #AmberPippinIQVIA
is a leading global provider of advanced analytics, technology
solutions and clinical research services to the life sciences
industry. 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. Learn more at -
https://jobs.iqvia.com We are committed to providing equal
employment opportunities for all, including veterans and candidates
with disabilities. https://jobs.iqvia.com/eoe As the COVID-19 virus
continues to evolve, IQVIA's ability to operate and provide certain
services to customers and partners necessitates IQVIA and its
employees meet specific requirements regarding vaccination status.
https://jobs.iqvia.com/covid-19-vaccine-status Similar Jobs (3) QA
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4 Days Ago About Us IQVIA is a world leader in using data,
technology, advanced analytics, and expertise to help customers
drive healthcare - and human health - forward. Together with the
companies we serve, we are enabling a more modern, more effective
and more efficient healthcare system, and creating breakthrough
solutions that transform business and patient outcomes.
To get there, it takes diverse skills and a curiosity to explore
new possibilities. No matter your role, everyone at IQVIA,
including our colleagues at Q - Solutions, contributes to our
shared goal of improving human health. Thank you for your interest
in growing your career with us.
Keywords: IQVIA LLC, Durham , QA Associate Director - Hosting Regulatory Inspections, Executive , Durham, North Carolina
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