Manager Global Quality Systems Auditor

US-NJ-Princeton
Requisition ID
2017-9683

Overview

Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) is an innovative, fast-growing healthcare company that discovers and develops new compounds that address unanswered medical needs and advance human health. With a strong focus on neuroscience, oncology, and cardio-renal treatments, OPDC is dedicated to improving the health and quality of human life. For more information, visit www.otsuka-us.com.   

 

OPDC is a subsidiary of Otsuka America, Inc. (OAI), a holding company established in the U.S. in 1989. OAI is wholly owned by Otsuka Pharmaceutical Co., Ltd. The Otsuka Group employs approximately 42,000 people globally and its products are available in more than 80 countries worldwide. Otsuka welcomes you to visit its global website at https://www.otsuka.co.jp/en/.

Responsibilities

The Manager of Global Quality Systems Auditor will provide leadership, expert advice, and hands on capabilities to various types of audits that includes, but not limited to, supplier audits, computerized systems audit, and data integrity audit for regulated pharmaceutical industry. Primary responsibilities will be manager contributions for all audit activities risk-based computerized systems validation internal and third party supplier audit plan, including CAPA reviews and approvals, computerized system validation audit metrics management, and vendor management.  This role also will provide support for assigned Global Quality Systems operational responsibilities, such as the audit budget and intelligence sharing.  

  1. Participate in the creation and maintenance of the risk-based computerized systems validation internal and third party supplier audit plan and contributions to the global audit plan in coordination with the Global Quality Management and Global Product Quality teams, within the audit universe.
  2. Manage the computerized systems audits, including planning, supervising, conducting, follow up and support.
  3. Manage contract auditors in line with Otsuka’s business model and applicable SOPs.
  4. Ensure computerized systems validation audit contributions to other Global Quality team audits as required.
  5. Support continuous improvements, such as addressing areas of risk identified from individual audits and lessons learned that can be leveraged globally to assist in corporate risk reduction and inspection readiness.
  6. Maintain an understanding of relevant regulatory requirements for computerized systems validation audits and keep informed on relevant changes to ensure information sharing and advice, to enable Otsuka to improve and maintain a computerized system audit program in a manner consistent with these requirements.
  7. Support the globalization of computerized system validation audit SOPs (Standard Operating Procedures), where applicable, and in line with company practices and applicable worldwide guidelines and regulations.
  8. Assist in Global Quality Systems audit related budget preparation, updates, and management, as well as related contracts.
  9. Contribute to local, regional, or global regulatory inspection preparation, participation, and responses, as applicable to computerized system validation.
  10. Collaborate with Global Quality to support necessary cross-training for computerized systems validation audit foundational understanding and support on-going efforts as needed.
  11. Assist Global Quality Management in establishing corrective action and preventative action (CAPA) management services for Functional teams around computerized system validation audit CAPAs to improve and streamline CAPA closures.
  12. Provide data for the Global Quality System computerized system audit metrics and key performance indicators (KPIs), including trends analyses from internal / external audits and lessons learned to advise on risk mitigation plans.
  13. Partners with the other Global Quality teams in order to ensure a cohesive and effective functioning model for Global Quality.
  14. Supports the onboarding and ongoing training of Global Quality Systems Computerized System Validation Audit personnel (employees and contractors), including access and tool / system uses.
  15. Liaises with other external non-Otsuka quality groups as needed.

Qualifications

Required:

  • Bachelor’s degree and at least 8 + years professional work experience in audit. A minimum of three years’ experience as a lead auditor.
  • Demonstrated experience in computerized systems audits and audit management
  • Significant knowledge/understanding of GxP and non-GxP relevant regulations.
  • Preference for experience in performing audits in a global quality environment
  • Familiarity with FDA, EMA, and PMDA requirements
  • Strong knowledge of Pharmaceutical industry systems and processes
  • Excellent knowledge of regulatory requirements as they relate to systems development, validation and data Integrity audits 
  • Ability to manage and supervise other including managed service providers and vendors 
  • Demonstrated skills in quality & compliance – CAPA programs, Internal audit programs, SOP programs
  • Leadership on external audit facilitation and corrective action programs
  • Proficient use of Microsoft Office products suite
  • Results oriented: Maintains focus that yields outcomes. Demonstrates the ability to meet goals and targets whether they are individual goals, team deliverable, or the timely completion of duties and projects
  • Communication skills: Effective in written, spoke and listening activities. Thoughts are conveyed in a clear, concise and timely manner. Must be able to effectively convey complex or difficult information. Listens carefully to understand various points of view and is easy to approach.
  • Problem solving skills: Demonstrates the ability to anticipate and identify core problems, apply insightful analysis, and solve problems effectively. Must be willingly confronts tough or difficult issues.
  • Detail Oriented: Demonstrates ability to set and communicate audit goals and standards for Otsuka. Administratively sound in the running of the audit office and meeting Otsuka and industry requirements for reporting. Maintains good records, organized, and timely. 
  • Initiative: Must be proactively seeks out and accepts accountability for new and difficult challenges in the field of responsibility.
  • Flexibility: Demonstrates the ability to manage change. Maintains controls for outcomes even when confronted with changes or new direction. Understands that there are often no single right answers. 
  • Enthusiasm: Demonstrates a strong desire to accomplish and earn success. Instills a sense of team spirit among peers and team groups. Affects group in a positive manner. Maintains a realistic perspective balanced with strong optimism.

Preferred:

  • Lead Auditor/Internal Auditor Certificate for quality management systems
  • Experience with Trackwise System for handling deviations, change controls, investigations, CAPAs.

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