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Senior Director, GxP Audits in Bernards, NJ at DSI

Date Posted: 4/27/2019

Job Snapshot

Job Description

Join a Legacy of Innovation 110 Years and Counting!

With over 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. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with a Competitive Advantage in Oncology,” Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.

Job Summary:
This role is accountable for setting the strategic direction & providing leadership of audit functions of teams primarily based in the US, with a cross collaboration of teams based in, Europe, Asia and Latin America. Ensures the development, execution of a risk based audit program and effective CAPA management resulting from audits. HA Inspections, non- compliance and incidence or deviations. Provides vision and strategy of high complexity & provides global / local leadership for the audit program. 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.
This position establishes framework for monthly corrective/preventive actions (CAPA) updates across the GxPs to ensure that the organization is in perpetual state of compliance. This position is responsible for reviewing and evaluating CAPA and the CAPA effectiveness program and communicating CAPA status to cross-functional departments and management and ensures that the CAPA metrics and trending are being reported on a monthly basis.

Responsibilities:

Leadership/Audit Program:
  • Establish a central audit function across GxPs and ensures proper oversight of GxP audit program to contribute to DSG business priorities and strengthen and renew in accordance to a change of environment.
  • Responsible for managing and establishing 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 partners, affiliates, and vendors.
  • Ensures quality update of the audit program and ensures the plan is fully aligned with the company’s strategy and objectives.
  • Oversee compliance auditing program to fulfill regulatory requirements.
  • Audit and qualify vendors and services providers for GxP activities and assure GxP compliance of vendors and services providers.
  • Leads, directs and / or performs internal audit and assure GxP compliance of internal operations.
  • In collaborate with global QA management and stakeholders of internal and external functions to establish and provide the effective audit plan and manage the effective audit.
  • Establishes quality metrics for audits and inspections and execute against these metrics consistently.
  • Executes and reports to senior management on high profile audits such as directed audits and fraud investigations.
  • Supports GCP/PV and or GMP/IMP QA team in identifying and defining quality improvement initiatives for development activities/ programs
  • Approve the GxP audit plan including Study Specific Audit Plan (SSAP), Vendor audit, System audit and submission audit etc.
  • Responsible for review and approval the audit report and CAPA.
Corrective and Preventative Action (CAPA) Plans and CAPA Effectiveness Check:
  • Establishes framework for monthly CAPA updates across the GxPs to ensure that the organization is in perpetual state of compliance.
  • Provides 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 external functions.
  • Takes initiatives to report on CAPA trends, common root cause and areas of improvement and in close collaboration with CAPA Manager.
  • Responsible for updating and maintaining the all GxP audit information to enter the eQUTE in timely manner for overseeing and providing the metrics and trending Quality Status to global QA management and to stakeholders of internal and external functions.
Regulatory Inspections Leadership:
In collaborate with Head of QA GCP CSPV PV and business function, to provide strategy of regulatory inspection preparation, and aligns regulatory inspection activities for complex inspection preparation, facilitation, and follow up activities.

Strategic Quality Leadership:
  • Applicable GCP, CSPV and PV Quality standards/requirements and their implementation supported
  • No delays in the launch of products due to insufficient GxP QA compliance
  • Continuous improvement opportunities and system/process upgrades are identified and built into the annual objectives/Quality Plan cycle
  • KQIs related to GCP, CSPV and PV that are routinely reported from the line functions are consolidated across all regions and reported to strategy and operations lead.
  • Issues are adequately and timely escalated.
  • Development, completion and execution of GxP audit program (Audits, audit reports, corrective action plans) according to defined process (SOPs) and timeline
​ Organizational and personnel leadership:
  • Manages talent, performance of direct reports and ensure adequate succession planning.
  • Recruitment/ retention and development of talent
  • Providing QA leadership to these multiple functions re-quires a profound understanding of the science, processes, operations, stake holder management, influence& diplomacy.
  • Understanding of global expectations of Health Authorities
  • Thorough and extensive knowledge of ICH- GCP including FDA/PMDA/EU regulations, pharmacovigilance, new drug regulations, other key HA guidance’s, and current industry practice
  • Organizational awareness
Qualifications

Education and Experience
  • Required Bachelor’s Degree or higher in Life Sciences, Pharmacy or Medicines. PhD in Life Sciences, Pharmacy or 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 trial/ PV
  • Knowledge of drug development
  • Understanding of global expectations of Health Authorities
  • Thorough & extensive knowledge of ICH- GCP including FDA/PMDA/EU regulations, pharmacovigilance, new drug regulations, other HA guidance’s, & current industry practice
  • Considerable organization awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally and in global teams across different regions of the world
Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. All 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.