• APAC Auditor, DCM

    Requisition ID
    2018-5464
    # of Openings
    1
    Job Location(s)
    N/A 31 China
    Travel
    20-30%
    Education
    Bachelor's Degree, Master's Degree
    Position Type
    Full Time
    Category
    Contract Mgmt/Legal/Patents
  • Overview

    Under the direction of the Global Audit Manager, DCM, coordinate the DCM audit process in the Asia Pacific Region, including the detailed auditing of distributors, sub distributors and all relevant third and/or fourth party intermediaries in this region.

    Responsibilities

     

     

    • Ensure our distributors and other third and/or fourth party intermediaries governance practices are assessed in all laws under The US Foreign Corrupt Practices Act (FCPA), UK Bribery Act and other relevant legal and all applicable regulatory requirements.
    • Ensure our distributors and other third and/or fourth party intermediaries quality practices are assessed in terms of the applicable elements of ISO13485:2016, the Medical Device Regulation 2017/745 (5.5.2017) and other relevant quality standards.
    • Work with the Global Audit Manager, DCM, to create a comprehensive audit schedule for all distributors, sub distributors and relevant third and/or fourth party intermediaries in the region.
    • Responsible for the planning, execution and post-processing of distributor audits, maintaining records and reporting findings cited during audits on an effective and timely basis.
    • Prepare audit reports and communicate with our internal team and to our distributors within agreed time frames, ensuring all audit findings are effectively contained and communicated and/or escalated to the appropriate parties.
    • Manage post-audit activities, and follow up on any necessary corrective and preventive actions.
    • Create and foster a strong working relationship with the different regional functions and divisions, and additional key interfaces to facilitate effective collaboration.
    • Support change and process improvement initiatives related to Auditing, Inspections and other compliance processes.
    • Where required, serve as lead auditor, leading a team of auditors, technical experts, or auditors-in-training.
    • Support the preparation of the global annual audit schedule, using risk-based approaches.
    • Perform a risk-based verification and effectiveness check on key distributor audits and inspections.
    • Willingness & availability to travel on company business.
    • Ensure that Cooks Code of Conduct is considered in all business matters carried out on Cook’s behalf.

     

    Qualifications

    • Relevant bachelor’s degree or equivalent in business, risk, quality, audit or compliance related fields desired.
    • A minimum of five years’ experience in life science compliance / regulatory auditing function.
    • Fluency in English and one Asian language.
    • Demonstrated ability to keep abreast of and adapt to changing regulatory environments.
    • Understanding risk and risk management techniques, to include identifying and analysing business processes, key risks and controls.
    • Familiar with international Anti-Corruption standards and enforcement efforts.
    • Analytical approach to problem solving with the ability to identify and implement solutions.
    • Ability to take experiences from one market and consider possible implications in other markets. Ability to adapt to fast changing environment.
    • Demonstrated ability to establish priorities, meet deadlines, work under pressure & ensure quality standards are achieved.
    • Excellent interpersonal and communication skills. Able to work with people from different levels and countries.

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