Director, Clinical Quality Assurance RWE Clinical Trials
Company: WALGREENS
Location: Deerfield
Posted on: June 23, 2022
Job Description:
Job Summary
The Director, Clinical Quality Assurance for the RWE Clinical Trial
business will be responsible to proactively assess and identify
risks, provide leadership for the development of the new quality
function, and expertise to ensure business is performing to Good
Clinical Practice (GCP) standards. This role will also be
responsible to provide quality assurance oversight and management
activities of clinical trial operations and study protocols in
accordance to GCP guidelines, applicable regulations and quality
standards. The Director, Clinical Quality Assurance will work
closely with the Senior Director, Regulatory Affairs, to develop
the clinical trial quality framework to support the execution of
clinical trials including individual clinical trial review plans to
be delivered to internal and external project teams. The Director,
Clinical Quality Assurance will be responsible to proactively
identify and communicate key business or study risks and oversee
action plans to mitigate the risks. The role will also be
responsible for the monitoring and trending of quality issues,
metrics, investigation, and CAPA management to ensure the clinical
trials business is biopharmaceutical inspection readiness
activities are in place. This role will also be responsible to
ensure the internal Walgreens clinical trial study team members are
prepared to represent GCP. Reports to Senior Director, Regulatory
Affairs, RWE Clinical Trials
Job Responsibilities
- Provide overall leadership for the clinical trial quality
function and responsible to establish comprehensive clinical trial
quality processes and systems
- Lead the development, implementation, and communication for the
overall quality strategic plan in line with GCP and other clinical
trial regulations.
- Responsible for writing and maintaining procedural documents
(SOPs) to ensure clinicals business adheres to the industry
regulatory standards (e.g., audit, CAPA and Quality Issue
Management, regulatory inspections, quality risk management).
- Accountable for the QA review of documentation and documents
submitted to regulatory agencies, including IRBs, biopharmaceutical
customers, and publications
- For the assigned studies, leads quality issue investigations,
root cause analysis and CAPA development and assist study teams in
implementing corrective and preventive actions in support of
sustainable compliance.
- Maintain a contemporary knowledge of current industry trends,
standards and methodologies as it relates to GCP
- Understand and interpret FDA agency policies and guidance as it
pertains to the clinical trial work being conducted
- Liaise with other Walgreens clinical trial team members and
external parties including, physician and Walgreens sites and
partners to promote high level of quality and consistency across
and within clinical trials
- Provide QA review of study protocols to identify operational
risks and collaborates with study team in development of risk
mitigation strategies.
- Develops risk-based audit plans for assigned programs, ensures
audits are conducted in accordance with the plan, reviews audit
reports, evaluates responses and CAPA plans in accordance with
SOPs
- Leads the development and implementation of continuous quality
improvement initiatives by establishing and tracking key
performance quality standard metrics and utilizing data to embed
continuous improvement principals across the clinical trials
business
- Perform ongoing review of existing policies and procedures
(SOPs) identifies gaps, and leads the development of new and
updated SOPs align with the current regulatory standards and
Walgreens Corporate policies
- Develop and mentor staff through on-boarding, open
communication, training and development opportunities and
performance management processes; build and maintain employee
morale and motivation; ensure the team is appropriately staffed
with required competencies; foster a diverse and inclusive
workplace.An Equal Opportunity Employer, including
disability/veterans
About Walgreens Boots Alliance
Walgreens Boots Alliance (Nasdaq: WBA) is a global leader in retail
pharmacy, impacting millions of lives every day through dispensing
medicines, and providing accessible, high-quality care. With more
than 170 years of trusted healthcare heritage and innovation in
community pharmacy, the company is meeting customers' and patients'
needs through its convenient retail locations, digital platforms
and health and beauty products.
Including equity method investments, WBA has a presence in more
than 25 countries, employs more than 450,000 people and has more
than 21,000 stores.
WBA's purpose is to help people across the world lead healthier and
happier lives. The company is proud of its contributions to healthy
communities, a healthy planet, an inclusive workplace and a
sustainable marketplace. WBA is a participant of the United Nations
Global Compact and adheres to its principles-based approach to
responsible business.
WBA is included in FORTUNE's 2021 list of the World's Most Admired
Companies. This is the 28th consecutive year that WBA or its
predecessor company, Walgreen Co., has been named to the list.
More company information is available at
www.walgreensbootsalliance.com
Basic Qualifications
- Bachelor's degree and at least 6 years OR High School/GED and
at least 9 years biopharmaceutical, CRO, or other related
industry
- Experience in biopharmaceutical, CRO, or other related
industry
- Experience in a Quality and or Clinical Operations environment
with expert knowledge and hands on experience with GCP audits
- Knowledge of ICH GCP guidance for clinical development
including operating in a real world evidence environment
- Experience with all phases of clinical trial development
involving drugs, biologics, devices and drug/ device
combinations
- Experience with management processes and requirements,
including investigation, root cause analysis, CAPA plan development
and effectiveness checks
- Experience translating biopharmaceutical needs for innovation
and creative approaches to quality management
- Knowledge of scientific education and experience managing
quality oversight for clinical trials, understands medical
terminology, standards of care and disease states to assure the
ethical treatment of subjects enrolled into trials
- At least 2 years of experience contributing to financial
decisions in the workplace.
- At least 3 years of direct leadership, indirect leadership
and/or cross-functional team leadership.
- Willing to travel up to/at least 20% of the time for business
purposes (within state and out of state).
Preferred Qualifications
- Master's degree
- Proficient in using Microsoft Office applications is an asset
(MS Word, MS Excel, MS PowerPoint, Visio)
Keywords: WALGREENS, Arlington Heights , Director, Clinical Quality Assurance RWE Clinical Trials, Healthcare , Deerfield, Illinois
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