QA Associate Director - Hosting Regulatory Inspections
Company: IQVIA
Location: Houston
Posted on: May 28, 2023
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Job Description:
Remote Opportunity - USA or Canada
Purpose:
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 matters
Required 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:
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 #AmberPippin
IQVIA 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
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.
EEO Minorities/Females/Protected Veterans/Disabled
Keywords: IQVIA, Houston , QA Associate Director - Hosting Regulatory Inspections, Executive , Houston, Texas
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