Abbott Global Audit and Due Diligence Quality Manager in Dublin, Ireland
Abbott in Ireland
In Ireland, Abbott employs almost 3,000 people across 10 sites. Abbott has six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third party manufacturing management operation in Sligo. It has commercial, support operations and shared services in Dublin. Abbott serves the Irish market with a diverse range of health care products including diagnostics, medical devices, nutritionals and branded generic pharmaceuticals. Abbott has been operating in Ireland since 1946.
Abbott Established Pharmaceuticals Division – Dublin
Abbott Mature Products Management Ltd./Established Pharmaceuticals Division in North Dublin supports the growth of Abbott’s mature pharmaceutical brands globally. Strategic Medical Affairs, Marketing, Quality Assurance, Business Development, Purchasing and Regulatory Affairs at EPD Dublin support Abbott affiliates in both developed and emerging markets.
We currently have a vacancy for a Global Audit and Due Diligence Quality Manager to be based in Dublin Ireland, Basel Switzerland or Weesp the Netherlands.
This position will include the following:
Primary Job Function
The role of the Global Audit and Due Diligence Quality Manager function is to manage on-site audits and Quality Questionnaires, related to Suppliers and Third Party Manufacturers that fall under the responsibility of EPD Global Audit and Compliance. As experienced senior level auditor, function is responsible for continuous improvement initiatives, global quality projects, auditor training program, risk assessments and due diligence audits/projects as applicable. The individual may function as the primary Quality Lead for assigned EPD global product acquisition and in-licensing deals. Additionally, support on company acquisition due diligence activities is performed as assigned.
List the primary tasks and/or activities this job performs on an ongoing basis.
Manage on site audit for 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.
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 CAPA follow-up to close for 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
A Global Audit and Due Diligence Quality Manager, 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. It serves to protect Abbott stakeholders by providing gap analyses, recommendations, and assurance that priorities are addressed based on risks/benefits for existing global Suppliers and TPMs and due diligence activities.
Bachelor Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area
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
EPD Established Pharma
Ireland > Dublin : Block B
Ie - 35.0Hst0 (Ireland)
Yes, 50 % of the Time
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 150 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.
The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.
We invite you to explore opportunities at Abbott , to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.
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