Job Responsibilities:

1. Manage on site audit for EPD Manufacturing sites and Global Suppliers and Third Party Manufacturers (TPMs) worldwide.
2. Support effective management of EPD quality Due Diligence process and activities related to EPD global product acquisition and in-licensing deals.  
3. Plan and lead due diligence audits for new playbook deals through on site audits/ desk to audits.  Compile the DD audit reports/elevation slides to summarize the risks associated with potential partners and to ensure timely communication with cross functional teams/project leads
4. Support any assigned EPD company acquisition activities providing support to the QA Lead and ensuring key quality risks and mitigation measures are identified, protecting Abbott and patient.
5. All activities required to plan, prepare for, conduct, report and close the assigned audits. 
6. Ensure that all audit related information is documented into the Audit Tracking system in a timely manner.
7. Assess the appropriateness and timeliness of proposed CAPAs, and track designated CAPA follow-up to close for EPD Manufacturing Sites, Suppliers and TPMs globally.
8. Timely information on the audits to management and stakeholders. Escalation of any critical findings or negative audit outcomes to EPD senior management, in line with the applicable policy and procedures. 
9. Reviewing any Quality Questionnaires returned by the Suppliers and resolve any issues. 
10. Read and extract developing regulations and trends from available sources to provide recent perspectives during audits.
11. Ensure a proactive determination of regulatory, compliance and quality issues and integrate them into audits/assessments on a priority basis.  
12. Responsible for communication and documentation of internal and external compliance related information.  Includes changes in regulations, new guidelines and guidance documents from regulatory authorities and trade organizations. 
13. Responsible for leading continuous improvement initiatives including creation, scoping and implementation.
14. Manage assigned global quality projects and compliance initiatives. 
15. Participate as member of Global Audit Peer Review team responsible for review of audit reports and identification of training needs for the team.
16. Train and support global auditors and monitor effectiveness of training and compliance to requirements.
17. Takes lead on assigned cross-functional team projects in a structured business environment in accordance with internal procedures and external regulations
18. Provide support to EPD plants and Global Third Party Manufacturing Operations QA, Distribution QA and Development QA in the timely resolution of issues related to suppliers and TPMs.  Discuss with and agree with the supplier and TPM on a timely implementation of corrective and preventive actions, as needed to prevent recurrence. 

Required Qualifications:

1. Bachelor Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area 
2. At least 10 years in the Pharmaceutical Industry and/or Government Regulatory Agency; and at least 5 years of GXP Auditing experience, with a minimum of 3 years as lead auditor, leading audits related to GMP, GDP or ISO 
3. Strong knowledge and understanding of the EU, FDA, PICs, WHO and other relevant GMP and ICH guidelines and regulations.
4. General knowledge of technical, chemical and pharmaceutical processes, validation procedures and analytical methodology,
5. Capable of understanding and overcoming different cultural and language obstacles to provide solution that satisfy, corporate, regional and local objectives.
6. Capable of analyzing data in in order to support the development of strategies to effectively manage the action plans that will resolve the issues.
7. Excellent verbal and written communication skills in Business English
8. Excellent project management skills. 
9. Excellent knowledge of data integrity regulations and requirements

#LI-DNI