JOB DESCRIPTION:

Abbott is a global health player, committed to more than just helping people live longer and better lives. Abbott employs approximately 110,000 employees in160 countries worldwide on a diverse portfolio of diagnostics, medical devices, nutrition and pharmaceuticals. In the Netherlands, 2000 colleagues at 9 locations are working on sustainable solutions for important health challenges.

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. 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

• 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.

Education & Experience/ Knowledge Required

• 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 for Pharma, Medical Devices and Nutritional product types.
• 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

How do you apply?

Do you enjoy working in an international organization that contributes to healthcare and do you recognize yourself in this profile, then we would like to receive your response.

You can apply with your CV and motivation via our website. For more information, please contact the Abbott recruiter at recruitment.netherlands@abbott.com.

What are the next steps after the application?

The recruiter will contact you. If it appears that your profile fits the position, the job interviews will be scheduled. Part of our selection procedure is checking references and submitting a Certificate of Good Conduct. An assessment can be part of the application process.

We are looking forward to your reaction!

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Quality Assurance

DIVISION:

EPD Established Pharma

LOCATION:

Netherlands > Weesp : WHS 02

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 50 % of the Time

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Not Applicable