QA Manager Global Audit and Due Diligence

QA Manager Global Audit and Due Diligence - Abbott Pharma JOB DESCRIPTION:
Abbott Established Pharmaceuticals (EPD) is looking for two
QA Manager Global Audit and Due Diligence This Position can be hired within the EPD Locations in Italy, Germany, Ireland or Netherlands and will have travel of 30-50% globally
Primary Job Function
The role of the EPD QA Manager Global Audit and Due Diligence is to manage the evaluation of Global Suppliers, Third Party Manufacturers, and EPD internal locations via the supplier and internal audit program and aligned with scope of auditor certification.
Additionally, responsible for APO AG Medical Device Internal Audit program support and audit execution. As experienced senior auditor, 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.
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. Manage on site and desktop audits of Global GCP/GLP Suppliers, CROs and investigating Sites (aligned with scope of completed auditor certification).
Responsible for APO AG Medical Device Internal Audit execution and support of all necessary schedule and audit process activities.
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 Importante Azienda 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, asneeded to prevent recurrence.
Supervisory/Management Responsibilities
None
Position Accountability / Scope
The Quality Manager Global Audit and Due Diligence reports to the Head of Global Audit and Due Diligence. This position partners with Global GCP/GLP QA, 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, APO AG Medical Device organization, CRO and Investigator sites and due diligence activities.
Minimum Education
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 for Pharma, Medical Devices and Nutritional product types. Additional on the job training and certification in GCP audits or equivalent work experience.
Strong knowledge and understanding of the EU, FDA, PICs, WHO and other relevant GMP and ICH guidelines and regulations, including ISO 9001 and ISO 13485.
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
JOB FAMILY:
Operations Quality DIVISION:
EPD Established Pharma LOCATION:
Italy >Rome:
Via Giorgio Ribotta 9 ADDITIONAL LOCATIONS:
Germany >Hannover:
48, Germany >Neustadt am Rübenberge:
210, Ireland >Dublin:
Block B, Netherlands >Olst:
OAA/OAB, Netherlands >Weesp:
WHS 02 WORK SHIFT:
Standard TRAVEL:
Yes, 25 % of the Time MEDICAL SURVEILLANCE:
Not Applicable SIGNIFICANT WORK ACTIVITIES:
Not Applicable
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 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s Importante Azienda-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 Importante Azienda.