Audit Manager, APAC

Reporting to the Director Global Audit - GCA, the APAC Audit Manager - GCA will oversee the GCA audit process in the Asia Pacific Region, including the planning of governance and quality audits of distributors, sub distributors and all relevant third and/or fourth party intermediaries in this region. This role will lead the audit team and work with a broad range of Cook Medical functional units, including Quality Assurances, Ethics & Compliance, Legal and Finance, along wiht their GCA colleagues.

1. Ensure that our distributors and other third and/or fourth party intermediaries governance practices are assessed against the Cook Business Handbook for Distributor, the US Foreign Corrupt Practices Act (FCPA), the UK Bribery Act, and all other relevant National Anti-Bribery and Anti-Corruption Acts, Competition Acts and Data Privacy Acts, as well as all other applicable legal and regulatory requirements.

2. Ensure that our distributors and other third and/or fourth party intermediaries quality practices are assessed against the applicable elements of the ISO13485:2016 standard, the Medical Device Regulation 2017/745 (5.5.2017), and other national quality standards (e.g. GDP, GSP, etc.) and the requirements in the Cook RAQA Policy as part of the Third Party Distributor Agreement.

3. Ensure that the CMMS Procedures for the GCA Audit function meet all regulatory requirements in the Asia Pacific region and support the Director Global Audit in change and process improvement initiatives related to Auditing, Inspections and other compliance matters.

4. Prepare the audit schedule for all distributors, sub distributors and relevant third and/or fourth party intermediaries in the region by using a risk-based approach.

5. Serve as lead auditor, leading a team of auditors, subject matter experts, executing the scheduled distributor audits, maintaining records and escalating findings to the appropriate parties on an effective and timely basis.

6. Manage post-audit activities, and follow up on any necessary corrective and preventive actions.

7. Create and foster a strong working relationship with the different regional functions and divisions, to facilitate effective collaboration.

8. Supervise, coach and develop other audit team members.

1. Degree holder in relevant discipline
2. A minimum of 8 years’ experience in life science compliance / regulatory auditing function.
3. Solid working background in multinational medical device company is required and experiences in regulatory requirements in APAC market is preferred.
4. Familiar with international Anti-Corruption standards and enforcement efforts.
5. Fluency in English and one Asian language.
6. Ability to travel domestically, internationally and weekends as needed up to 30%.
7. Demonstrated ability to keep abreast of and adapt to changing regulatory environments.
8. Understanding risk and risk management techniques, to include identifying and analyzing business processes, key risks and controls.
9. Proficient in Microsoft Office Excel, Word, Access and PowerPoint
10. Excellent analytical and problem-solving skills to identify and implement solutions.
11. Ability to take experiences from one market and consider possible implications in other markets. Ability to adapt to fast changing environment.
12. Demonstrated ability to establish priorities, meet deadlines, work under pressure & ensure quality standards are achieved.
13. Excellent interpersonal and communication skills. Able to work with people from different levels and countries.
14. Leads by example, guides performance & support development of others, acknowledging strengths and accomplishments.