Head of SQA and CSV, RDS IT - Director
Company: IQVIA Argentina
Location: Durham
Posted on: April 10, 2021
|
|
Job Description:
Primary Location: Durham, North Carolina, United States
Additonal Locations: Plymouth Meeting, PA Full time R1185839 Date
Posted: 03/19/2021 Head of SQA and CSV, RDS IT Job Overview:--
Accountable for strategic leadership and overseeing of R&DS
IT's end to end Software Quality assurance (SQA) and Computer
systems validation (CSV) function globally. The role serves as the
primary interface for internal and/or external audits and
inspections including but not limited to coordination with
applicable authorities, IQVIA's security, privacy, or legal
offices. The key responsibilities include:-- SQA & CSV Standards,
Tools, and SDLC methodology:-- Own, manage, evolve, and enforce RDS
IT SQA tools, standards, and methodologies, identify and implement
improvement opportunities, establish, measure and report on
appropriate KPI for the department. The incumbent is also
responsible for the evolution and agile transformation of RDS IT
SDLC, SOPs, work instructions including tools /process
implementation and training/change management. This also includes
overseeing the certification and recertification process of CMMI
Maturity Levels. Quality risk management and mitigations:--
Provides strategic direction and oversight to development,
execution, and continual improvement of quality risk
management/mitigation strategies for all RDS IT program area as
well as partner with the broader IQVIA tech organization to resolve
applicable issues and concerns including coordination with IQVIA's
privacy, legal and security office for such privacy and security
issues. Provide oversight to the Implementation of risk-based
approaches to quality for IT programs e.g. Quality by Design
principles, risk-based quality management (RBQM) and ensures
effectiveness of mechanisms for ongoing quality risk monitoring,
mitigation, and management. Track the effectiveness of corrective &
preventative actions (CAPA) developed by product teams and ensure
the adequate and timely implementation of CAPA commitments.--
Periodic internal IT audits and inspections readiness:-- Perform
periodic audits and inspections of all RDS IT program area in
accordance with internal SQA and CSV functions to ensure
compliance. The incumbent is also responsible to coordinate all
audits and inspections activities for the organization in
accordance with relevant IQVIA stakeholders or internal /external
inspectors, business stakeholders as applicable to support quality
outcomes and real time inspection readiness.-- Collaboration with
Software engineering teams:-- Collaborate with software engineering
team leaders and members to leverage technical experience and depth
to help bring more automation and efficiency to the development
process, contributing to DevOps , agile, CICD pipeline for higher
frequency, high quality software releases. Provide timely, accurate
updates to executive management. Incumbent is also responsible to
provide strategic guidance on all performance, scalability and
non-functional requirement (NFR), establishing and ensure adherence
to quality by design principal including privacy matters. Quality
metrics, measurement, and reporting:-- Develop, implement, and
maintain set of KPIs across RDS IT to perform quality assessments
and analyses, gain insights into program and systematic /procedural
risks , issues, drive continuous improvements initiatives, and
proactively communicate to relevant stakeholders including KPI
reporting to senior management. Provides leadership coordination
and direction to benchmarking with external peers and industry for
establishing QA operational performance
targets/goals in support of excellence, value, and, impact.
Proactively research and communicate industry and global quality
trends and initiatives to ensure compliance and to identify
continuous process improvement opportunities.-- People management
and leadership:
Lead team of SQA and CSV professionals in accordance with
organization's policies and applicable legislation to deliver on
business outcomes for RDS IT. Responsibilities include planning,
assigning, departmental goal settings, and directing work,
appraising performance, and guiding professional development.
Approve actions on human resources matters, including salary
administration.-- Departmental Budget, resources, software
products, and financial management:--
Develop SQA and CSV departmental budget, estimate SQA and CSV
estimate for IT programs and deliver according to project timeline
and allocated budget. Lead quality program activities for assigned
products - including but not limited to product quality reviews,
risk reviews, SDLC/process consulting, and audit support. Oversee
the tracking of quality programs. Software products, and
releases/projects with respect to milestones, deliverables, and
quality of demonstrated results. --- B.S./M.S./MBA (or equivalent
degree) and 12+ years of relevant work experience or relevant
comparable background combined with at least 5+ years of
management/supervisory experience.--
--- Broad and deep global health regulatory agency knowledge and
experience interpreting and applying GxP requirements. Extensive
experience in quality assurance, computer system
validation/qualification, Software Development and/or Software
Testing experience. Strong knowledge in CFR 21 Parts 11, GAMP5, IT
controls methodologies, Annex 11 electronic record/electronic
signature, and data integrity requirements, standards and
guidelines. Strong background and understand of MHRA, FDA and other
regulations. Working knowledge of software development lifecycle
(SDLC) models.
--- Professional association membership and participation
preferred, not required (e.g. RAPS, SQA (GCP/GLP), RQA etc.). Ideal
candidate is expected to be well versed in GDPR, HIPAA and other
patient privacy and safety relevant regulations. Ability drive
privacy and security matter with legal, privacy and security
functions are an added plus.
--- Knowledge and demonstrated experience in application of
risk-based quality principles in a pharmaceutical environment.
Proven ability to design/evolve and /or implement quality
strategies and operational planning and oversight in a
fit-for-purpose manner enabling effectiveness, flexibility and
adaptability in a dynamic and evolving business model.
--- Demonstrated budgeting, strategic planning, execution, and
project management skills required including working knowledge in
validation practices of various computerized systems (configurable
software, non-configurable software, off-the-shelf software).
--- Current knowledge of industry trends and best practices- for
progressive quality risk management in a regulated environment
including SQA functions, software testing, test automation and
quality by design principals.--
--- Creative, innovative leadership experience complemented with
strong change management experience, adaptability, resourcefulness.
Excellent communication skills and a proven track record of
Influencing/building/promoting a culture of Quality and Excellence.
Ability to multi-task and meet deadlines in a fast-paced
environment.
--- Prior experience with agile software development processes,
version control, configuration management, release management,
and/or software quality assurance combined with experience in
requirements decomposition and requirements a preferred
Qualifications.
--- Knowledge of established Software Quality Standards - CMMI
and/or ISO, specifically, experience working in organizations
achieving and maintaining CMMI certifications.
--- Experience working in biotech/pharmaceutical, software product
management or consulting/ services companies with relevant
experience. 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 IQVIA's
Talent Acquisition team at workday_recruiting@iqvia.com to arrange
for such an accommodation.
Keywords: IQVIA Argentina, Durham , Head of SQA and CSV, RDS IT - Director, Executive , Durham, North Carolina
Click
here to apply!
|
Didn't find what you're looking for? Search again!
Other Executive JobsAnalyst Relations Director, Utilities Global Business Unit Description: Development and implementation of business plans, marketing strategy, and forecasts for a product/service or vertical market. As a product analyst you will participate in every stage of the product life (more...) Company: Oracle Location: Raleigh Posted on: 04/19/2021 Sr. Technical Project Manager - Remote Description: Sr. Technical Project Manager - Remote- Req 218United States /Services - Professional Services /Full-timeCleo is a cloud integration technology company focused on business outcomes. Every day we ensure (more...) Company: Cleo Location: Raleigh Posted on: 04/19/2021 Restaurant General Manager Description: We Are Still Open, Growing, and Hiring Get Into the Burrito Business Last year, we promoted 11,000 Crew Members to Managers. This year, we don't plan on stopping. In 2021, we're adding 200 new restaurants (more...) Company: Chipotle Location: Raleigh Posted on: 04/19/2021 Salesforce Manager Description: Title Tech Lead At least 5 to 7 years of solid experience in Salesforce development Lightning Components Web Aura , Declarative, Apex Coding, Visual Force JavaScript with at least 3 full lifecycle (more...) Company: Xoriant Corporation Location: Raleigh Posted on: 04/19/2021 People Services Manager Description: Description br br Serves as the people manager responsible for attraction, selection and retention programs for company operations. Responsible for new Restaurant General Manager and above-store leadership (more...) Company: Pizza Hut Location: Raleigh Posted on: 04/19/2021 Production Manager [Management Consultant-New York Description: Management Consulting New York City, New York Atlanta, Georgia Boston, Massachusetts Washington, District Of Columbia Charlotte, North Carolina Milwaukee, Wisconsin Detroit, Michigan Columbus, Ohio Indianapolis, (more...) Company: DeWolff, Boberg & Associates Location: Raleigh Posted on: 04/19/2021 Physician - Family Medicine - Medical Director Primary Care Physician in Smithfield, NC Description: UNC Health consists of 13 hospitals and multiple clinics across the state. The coast to the mountains UNC Health provides expert and compassionate care to all. UNC Physicians Network UNCPN in partnership (more...) Company: UNC Health Care Location: Smithfield Posted on: 04/19/2021 CEO - Growing Inpatient Behavioral Health/RTC facility (Physician #) Description: If you are a Behavioral Health CEO looking to grow a well respected inpatient/RTC facility don't miss this opportunity Join this inpatient mental health facility Company: Medsource Consultants Location: Raleigh Posted on: 04/19/2021 Assistant Manager - Hospitality - #537 - Days/Evenings Description: Assistant Company: Sheetz Location: Raleigh Posted on: 04/19/2021 Medical Director / Psychiatrist / Inpatient - Raleigh, NC Description: Medical Director, Behavior Health Services - PsychiatryStatus: Full time / Permanent OpportunityLocation: Raleigh, NCGroup profile:One the largest hospital systems Company: Reap Healthcare Agents Location: Raleigh Posted on: 04/19/2021 |