Director, GxP Audits
Company: Daiichi Sankyo
Location: Basking Ridge
Posted on: April 9, 2021
Director, GxP Audits in Basking Ridge, NJ at DSI Job
DescriptionJoin a Legacy of Innovation 110 Years and Counting!
Daiichi Sankyo Group is dedicated to the creation and supply of
innovative pharmaceutical therapies to improve standards of care
and address diversified, unmet medical needs of people globally by
leveraging our world-class science and technology. With more than
100 years of scientific expertise and a presence in more than 20
countries, Daiichi Sankyo and its 15,000 employees around the world
draw upon a rich legacy of innovation and a robust pipeline of
promising new medicines to help people. Under the Group's 2025
Vision to become a "Global Pharma Innovator with Competitive
Advantage in Oncology," Daiichi Sankyo is primarily focused on
providing novel therapies in oncology, as well as other research
areas centered around rare diseases and immune disorders.
This role is accountable for providing leadership to audit function
primarily based in the US reporting to the Head, Global GxP audits
with a cross collaboration of teams based in, Europe, Asia, and
Latin America. Oversight of end to end audit activities per audit
program of GxP relevant audit activities that encompasses the
systems and processes of the Daiichi Sankyo's GxP group and its
partners, affiliates, and vendors.
Ensure the coordination and execution of a risk-based audit program
and effective CAPA management resulting from audits, health
authority inspections, non- compliance and incidence or deviations.
Ability to implement proactive Global GxP Audit vision and strategy
within the responsible line function as well as improving
efficiency by optimizing process simplification and continuous
improvement initiatives at the regional and global levels. Together
with Regional DSI Management teams, plans, supports, conduct and
reports pre-clinical, Clinical Research (GCP), Pharmacovigilance
(PV) and Global Medical affairs (GMA) audits/inspections at
regional level and support across the organization and
- Leadership/Audit Program
- Provide proper oversight of the GxP Audit Program to contribute
to the DSG business priorities and strengthen and renew in
accordance to the changes in the clinical landscape.
- Manage and coordinate with the audit program for all types of
audits in the audit program of clinical studies that encompasses
the systems and processes of the Daiichi Sankyo's GxP group and its
affiliates and vendors.
- Ensure the Annual Audit Plans are fully aligned with the
company's strategy and objectives and adjust the plan using a
risk-based approach which would support business functions,
internal and external stakeholders to execute audits
- Ensure direct reports are qualified and assigned to execute the
annual audit plan effectively in the team based on the experience
- Lead the GxP compliance auditing program to fulfill regulatory
requirements, including and not limited to, performing internal
audits and identification of compliance issues and trends, review
of systems and procedures with appropriate education and
- Support quality metrics for audits and inspections and execute
against these metrics consistently.
- Execute and report to senior management on high profile audits
such as directed audits and fraud investigations.
- Support the GCP/PV and or GMP/IMP QA teams in identifying and
defining quality improvement initiatives for development
- Lead and support inspection readiness by preparing clinical
teams and CSPV for FDA/EU/key HA pre-approval and sponsor-monitor
inspections; provide inspection management support and follow-up
post inspection. Ensure that compliance commitments are fulfilled
- Corrective and Preventative Action (CAPA) Plans and CAPA
- Responsible for review, track and ensure the completion for
CAPA plans provided by vendors as part of monitoring activities for
Vendor Qualification Program.
- Establish a consistent framework for monthly and quarterly CAPA
updates across the audit team to ensure that the organization is in
a perpetual state of compliance.
- Provide management support for direct reports, assessment of
the CAPA metrics and its effectiveness, check system related to
audits to global QA management and to stakeholders of internal and
- Take initiatives to report on CAPA trends, common root cause,
effectiveness checks and areas of improvement and in close
collaboration with other QA, internal and external
- Responsible for updating and maintaining the all GxP audit
information to enter in the QMS in a timely manner for overseeing
and providing the metrics and trending Quality Status to global QA
management and to stakeholders of internal and external
- Collaborate with QA groups and business functions, to provide
strategy for regulatory inspection preparation, and align
regulatory inspection activities for complex inspection
preparation, facilitation, and follow up activities.
- Strategic Quality Leadership
- Applicable GCP, PV and GMA Quality standards/requirements and
their implementation supported.
- No delays in the launch of products due to insufficient GxP QA
- Development, completion, and execution of GxP audit program
(Audits, audit reports, corrective and preventive action plans)
according to defined process (SOPs) and timelines.
- Issues are adequately and timely escalated.
- Continuous improvement opportunities and system/process
upgrades are identified and built into the annual
objectives/Quality Plan cycle.
- KPIs related to audits are routinely reported from the line
functions consolidated across all regions and reported to the Head,
Global GxP Audits.
- Organizational and personnel leadership
- Talent management and performance of direct reports and ensure
adequate succession planning.
- Ensure that audit planning and audit assignment of complex/ key
projects to meet or exceed business needs by ensuring on-time
delivery of the audit program
- Providing QA leadership to multiple functions requires a
profound understanding of the science, processes, operations,
stakeholder management, influence& diplomacy.
- Understanding of global expectations of Health Authorities
- Organizational awareness including significant experience
working cross-functionally and in global teams across different
regions of the world.Qualifications: Successful candidates will be
able to meet the qualifications below with or without a reasonable
Education Qualifications (from an accredited college or
Required Bachelor's Degree or higher in Life Sciences, Pharmacy or
Master's Degree Life Sciences, Pharmacy or Medicines ,PhD in Life
Sciences, Pharmacy/Medicines preferred
- No less than 10 or more years of experience in Quality and
clinical development in the pharmaceutical industry with
involvement in regulated clinical trials/ PV Demonstrated
leadership and accomplishments in a global/matrix environment
Ability to travel up to 30% Domestic, International
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action
employer. Qualified applicants will receive consideration for
employment without regard to sex, gender identity, sexual
orientation, race, color, religion, national origin, disability,
protected veteran status, age, or any other characteristic
protected by law.
Candidates with Disabilities Who Require Assistance Daiichi Sankyo,
Inc. provides reasonable accommodation in job application
procedures for qualified individuals with disabilities and disabled
veterans. If you have a disability that inhibits your ability to
apply for a position through our online application process or you
otherwise need accommodation in connection with the recruiting
process due to a disability, you may use the alternative methods
described below to contact us about your interest in Daiichi
Sankyo, Inc. and/or to request an accommodation. Daiichi Sankyo,
211 Mt. Airy Road Basking Ridge, NJ 07920-2311
Attn: Staffing Dept. By Phone: Phone: 908-992-6400 Equal
Opportunity Employment Daiichi Sankyo, Inc. is an equal opportunity
/ affirmative action employer. Qualified applicants will receive
consideration for employment without regard to sex, gender
identity, sexual orientation, race, color, religion, national
origin, disability, protected veteran status, age, or any other
characteristic protected by law.
Keywords: Daiichi Sankyo, Newark , Director, GxP Audits, Accounting, Auditing , Basking Ridge, New Jersey
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