Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
In Germany, Abbott has more than 4,000 employees working in manufacturing, research and development, logistics, sales, and marketing. They are located at Abbott's German headquarters in Wiesbaden and its sites in Hanover, Neustadt am Rübenberge, Wetzlar, Eschborn, Cologne, Jena, and Hamburg.
Working at Abbott
At Abbott, you can do work that matters and help people to live healthier and fuller lives, grow your career, and learn, be your true self. You will have access to:
* Career development within an international company where you can grow your dream career
* An attractive benefits package (e.g., Abbott Pension Plan, a company bike, employee stock purchase program)
* A company recognized as a great place to work in many countries and named one of the most admired companies by Fortune
* Acknowledgment as one of the best large companies to work for, especially for diversity, working mothers, female executives, and scientists
* A challenging position in a fast-growing, crisis-independent industry
* The opportunity to be part of a dynamic, highly educated, and motivated team
* Flat hierarchies, an open and appreciative culture, and efficient communication
* A multinational environment fostering talent development
Abbott's Diagnostics Division is seeking an
Audit Program Manager (m/f/d) – Quality Assurance
based in Wiesbaden, Germany (remote) or other locations in Europe.
This role manages regulatory compliance activities related to the Internal Audit Program. It is key in facilitating and executing internal inspections, ensuring the audit program identifies quality system improvements across Abbott Diagnostic sites and commercial affiliates. The role includes conducting audits of suppliers and third-party manufacturers to assess compliance with external standards, regulations, and Abbott Quality System requirements at a level comparable to external audits.
Main responsibilities :
* Planning and conducting internal audits across Abbott Diagnostic sites to assess compliance with standards and regulations.
* Identifying compliance risks and guiding sites in quality system improvements.
* Preparing and implementing internal audit schedules for manufacturing sites, commercial affiliates, and supplier audits.
* Using current regulatory trends to identify potential risks or opportunities for improvement.
* Conducting audits to meet external audit standards.
* Leading initiatives to address compliance gaps, including developing CAPA plans and follow-up activities.
* Reporting audit progress to sites and division management.
* Providing guidance on inspection readiness activities.
* Performing specific topic audits as requested.
* Reporting audit findings promptly and generating internal audit metrics.
* Maintaining documentation related to inspections.
* Participating as SME in audits and providing strategic solutions to quality issues.
* Leading cross-functional projects and championing new initiatives.
* Staying informed on global standards, regulations, and bodies.
Your profile :
* Degree in science or a technical field such as biology, chemistry, engineering, or certification in Medical Technology or Quality Management.
* At least 5 years of experience in pharmaceutical, medical device, or regulated industries.
* Knowledge of GMPs, Quality System standards, and regulations like 21 CFR 820, 21 CFR Part 600, ISO 13485, IVDD.
* Training in auditing techniques; Certified Auditor or equivalent preferred.
* Background in In-Vitro Diagnostics (IVD) is advantageous.
* Fluent in English; German skills are a plus.
* Willingness to travel up to 75% annually.
Quality Assurance Manager
* Remote position in Spain
J-18808-Ljbffr
#J-18808-Ljbffr