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Manager Quality Assurance CAPA in Bernards, NJ at DSI

Date Posted: 5/16/2019

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 manages the CAPA process for audits, inspections, deviations and assessments in the Clinical development and pharmacovigilance area. Establishes a framework for CAPA process and appropriateness of action plans. Works in close collaboration with CAPA owners in the development of sound CAPA activities and rigorousness. Ensure proper deviation management in the GxP area.

Responsibilities:

CAPA and Deviation Management:
  • Ensure processes and systems are defined and implemented for central notification and tracking to oversee the CAPA management process for audits, inspections, deviations and assessments in the clinical development and pharmacovigilance area.
  • Collaborate with Clinical development (QM, PERM) on implementation of CAPA activities and ensure that CAPAs are appropriately investigated to ensure that the non- conformance would not be repeated; that CAPAs are assigned appropriate root cause and effectiveness of actions are duly implemented.
  • Ensure rigorous assessment of CAPA activities and documentation to assure compliance with applicable regulations and adequate compliance by partnering with GCP/PV QA and other QA teams as appropriate.
  • Develop a systematic approach for managing process deviations and assessing its impact. Ensure robust process is in place within DS on managing CAPAs and Deviations.
  • Takes a leadership role to review and asses all CAPAs stemming from Critical and / or major non-conformance as appropriate.
  • Accountable for assessing the efficiency of tools being utilized for CAPAs and deviation process and pioneer improvement as necessary.
  • Accountable for providing departmental training and guidance on CAPA and deviation system.
  • Develop business case and establish performance goals for continuous process improvement and organizational awareness, oversight plan for CAPAs and Deviations.
  • Ensure proper notification and oversight for full execution of CAPA commitments and due dates
CAPA Metrics and Trending:
  • Provide and ensure weekly, monthly CAPA updates to cross functional teams across the GxPs to ensure that the organization is in perpetual state of compliance.
  • May be required to present on CAPA status / effectiveness and or improvements at senior leadership team within the DS organization.
  • Liaise with QA vendor management to ensure that CAPAs / trends stemming from Vendor activities are remediated and that internal process controls are in place to prevent re-occurrence.
  • Ensure that a process is in place to collect minor observations trending reports and ensure it is duly classified and appropriated for necessary improvements and / or escalation.
  • In collaboration with QA standards and procedures, QM, GRDSOP committee; ensures that lessons learned from audits, process deviations, inspection trends, are duly reviewed and gaps assessed from a procedural standpoint to initiate process improvements as necessary.
  • May be tasked to lead a working group to introduce development metrics to engineer a performance management culture and accountability through implementation of KQI/KPIs across various functions in DS (ie, operations area, PV, regulatory affairs etc.),
  • Responsible for reviewing and evaluating corrective/preventive actions (CAPA) and the CAPA effectiveness program and communicating CAPA status to cross-functional departments and management.
  • Provides management support to CAPA owners, assessment of the CAPA metrics and its effectiveness.
  • Responsible for providing the status of CAPA to the GxP Quality Council.

CAPA update and supports for eQUTE:
  • In collaboration with QA audit planer, responsible for updating and maintaining the all GxP audit information to enter the eQUTE in timely manner
  • Responsible for entering CAPAs to the eQUTE and follow-up /implementation check for each CAPA on the eQUTE with auditors.

Administrator for eQUTE:
  • Responsible for providing the eQUTE training to the auditors and QA GCP CSPV PV team.
  • Responsible for the eQUTE as an administrative role and may be required to lead and or participate in change control management for eQUTE.

Review and evaluate CAPA:
  • Review Critical and / or Major CAPAs from HAs, audits and process deviations to determine their effectiveness.
  • Ensure and track on-time completion of CAPAs.
  • Identify opportunities for continuous improvement.

Information gathering and meeting:
  • Responsible for the GxP Quality Council Meeting as a facilitator role including the set up the meeting and prepare the meeting minutes etc.
  • May join the Quality Issues assessment meeting with QA GCP CSPV PV members.
  • Provide guidance for using CAPA related tools and processes, including leading root cause investigations and effectiveness check follow-ups
  • Mentoring and coaching cross functional teams on the CAPA process
  • Providing guidance on best practices and issue methodologies
Qualifications

Education and Experience
  • Required B.S. degree in scientific, health care, or related discipline; and/or background in Medical Health Profession (RN, Medical technologist, etc.)
  • At least 5+ years work experience in Quality or related field experience; Less experience may be appropriate with advanced degree.
Preferred Qualifications/Skills
Minimum 5 years of Quality Management System (QMS) management experience in the medical Pharma industry
Minimum 5 years of people/talent management experience
Minimum of 5 years of FDA experience inspections
Has a history of completing successful cross-functional projects and driving positive compliance outcomes.

Competencies
  • Strong people leadership skills and ability to influence others without direct authority
  • Should be creative and show initiatives, customer focused, results driven and be able to work effectively in a global environment.
  • Strong interpersonal and collaboration skills – collaborates across boundaries to create improvement initiatives.
  • •Experience with frontline auditor interface
  • •Experience in Root Cause Analysis methodologies
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.