QA Director - GCP Clinical Trials
Company: IQVIA
Location: Nashville
Posted on: May 29, 2023
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Job Description:
Home-Based - Remote Opportunity - USA and Canada
Position Overview:
This QA Director will support IQVIA Biotech Customers, as well as
be responsible for the Enterprise QA Audit Strategy. Provide
direction in support of customer accounts with quality and
compliance, and associated audit program where applicable. Provide
insights, analyses and support in the promotion and assessment of
compliance with regulations, guidelines, and operating procedures
within Americas or Globally where applicable.
Responsibilities :
Establish and maintain strong working relationships with internal
and/or external customer team leads and counterparts, as
assigned
Provide actionable insights to customer counterparts, QA Leadership
and Senior Management
Drive quality improvements and efficiencies along with risk
mitigation based on QA data analyses, operational performance data,
knowledge of process management, changing regulations and customer
expectations
Provide consultation and support concerning compliance with
regulations and appropriate controls, quality measures and risk
assessment and mitigation in the development of improved or new
service offerings across the business
Lead and project manage internal quality improvement initiatives as
assigned
Assist in enhancement and establishment of quality assurance and
control policy and risk identification and mitigation by providing
consultation and recommendations to regional and Enterprise QA
Leadership
Serve as author for QA Standard Operating Procedures (SOPs) as
assigned
Serve as QA representative on Standard Operating Procedures (SOP)
Taskforce(s) for other IQVIA functional areas as assigned
Participate in or lead teams for special projects as assigned.
Teams may be cross functional.
Provide guidance, interpretation, support, training, and key input
to development groups for consultation and interpretation of
regulations, guidelines, corporate standards, and policies
Conduct trend analysis of audit results and provide QA management
with initial root cause analysis
May present trend analysis results and QA metrics and insights to
IQVIA Senior management
May contribute to proper coordination of customer-initiated audits
and mock regulatory inspections, and manage regulatory facility
inspections
Recommend process and systems for audit, may contribute to the
development of the related audit plans and oversee the delivery of
these audits, review the Corrective and preventive actions (CAPAs)
and ensure appropriate follow up
Plan, schedule, conduct, report and close internal/contracted GCP
audit activities where applicable
May train/coach junior auditors to perform GCP audits in
Americas
Manage staff in accordance with organization's policies and
applicable regulations. Responsibilities include planning,
assigning, and directing work, appraising performance and guiding
professional development, rewarding and disciplining employees,
addressing employee relations issues and resolving problems.
Approve actions on human resources matters.
Oversee documentation, reporting, and closure of significant
compliance issues, audit/inspection findings
Support QA Management Leadership in proposal reviews and reporting
QA metrics and insights as assigned
Act as primary back-up for QA Leadership as assigned
Required Education and Experience:
Bachelors degree in life sciences or related field preferred
12 years Quality Assurance experience in pharmaceutical, CRO,
biotech or related area
5 years of Line Management Experience
Or equivalent combination of education, training and
experience.
GCP Auditing skills (Planning, preparation, conduct, reporting and
follow up)
Ability to train and coach junior GCP auditors
Required Knowledge, Skills and Abilities:
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.
Senior Management experience in Quality Assurance.
Ability to influence and guide others at all levels of
management.
Demonstrated ability to lead and manage multiple
responsibilities.
Ability to manage costs effectively through appropriate resource
allocation.
Ability to articulate and define departmental needs and
processes.
Ability to establish and maintain effective working relationships
with coworkers, managers and clients.
Travel Requirement:
Domestic travel may be required. 2-3 times on average per
quarter.
May also include some international 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, Nashville , QA Director - GCP Clinical Trials, Executive , Nashville, Tennessee
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