Abbott QA Manager Global Audit and Due Diligence in Shanghai, China
Core Job Responsibilities
List the primary tasks and/or activities this job performs on an ongoing basis.
Manage on site audit for EPD Manufacturing sites and Global Suppliers and Third Party Manufacturers (TPMs) worldwide.
Support effective management of EPD quality Due Diligence process and activities related to EPD global product acquisition and in-licensing deals.
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
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.
All activities required to plan, prepare for, conduct, report and close the assigned audits.
Ensure that all audit related information is documented into the Audit Tracking system in a timely manner.
Assess the appropriateness and timeliness of proposed CAPAs, and track designated CAPA follow-up to close for EPD Manufacturing Sites, Suppliers and TPMs globally.
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.
Reviewing any Quality Questionnaires returned by the Suppliers and resolve any issues.
Read and extract developing regulations and trends from available sources to provide recent perspectives during audits.
Ensure a proactive determination of regulatory, compliance and quality issues and integrate them into audits/assessments on a priority basis.
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.
Responsible for leading continuous improvement initiatives including creation, scoping and implementation.
Manage assigned global quality projects and compliance initiatives.
Participate as member of Global Audit Peer Review team responsible for review of audit reports and identification of training needs for the team.
Train and support global auditors and monitor effectiveness of training and compliance to requirements.
Takes lead on assigned cross-functional team projects in a structured business environment in accordance with internal procedures and external regulations
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.
Position Accountability / Scope
The Quality Manager Global Audit and Due Diligence works with guidance from the Director of Global Audit and Due Diligence. This position partners with Global Compliance, Operations, Contract QA, Development, Purchasing and Supply Chain to ensure GxP compliance risks are raised and addressed globally in EPD sites, global Supplier and TPMs. A QA Manager Global Audit and Due Diligence, has the primary responsibility to perform audits and assessments, to participate in and lead strategic projects to evaluate and improve compliance to regulations and standards, to help assure availability of products and to prevent regulatory/quality problems. Serves to protect Abbott stakeholders by providing gap analyses, recommendations, and assurance that priorities are addressed based on risks/benefits for EPD manufacturing sites and existing global Suppliers and TPMs and due diligence activities.
Bachelor Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area
Minimum Experience/ Knowledge Required
-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
-Strong knowledge and understanding of the EU, FDA, PICs, WHO and other relevant GMP and ICH guidelines and regulations.
-General knowledge of technical, chemical and pharmaceutical processes, validation procedures and analytical methodology,
-Capable of understanding and overcoming different cultural and language obstacles to provide solution that satisfy, corporate, regional and local objectives.
-Capable of analyzing data in in order to support the development of strategies to effectively manage the action plans that will resolve the issues.
-Excellent verbal and written communication skills in Business English
-Excellent project management skills.
-Excellent knowledge of data integrity regulations and requirements
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org