AUDIT PROGRAM MANAGER (M/F/D) – QUALITY ASSURANCE

DESCRIPCION DEL PUESTO About Abbott 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 employees working in manufacturing, research and development, logistics, manufacturing, 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 a healthier and full life, grow your career, and learn, be your true self.
You will have access to.
Career development with an international company where you can grow the career you dream of An attractive benefits package (e.
.
attractive Abbott Pension Plan, a company bike, employee stock purchase program) A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
A challenging position in a fast-growing crisis independent industry To become part of a dynamic, highly educated, highly skilled, and motivated team Flat hierarchies, open appreciative mentality, and efficient, constructive lines of communication Multi-national environment, where we foster the development of our talents within the enterprise Abbott's Diagnostics Division is looking for an Audit Program Manager (m/f/d) – Quality Assurance in Wiesbaden, Germany (remote) or other locations in Europe.
This position administrates regulatory compliance activities related to the Internal Audit Program.
The position is key in the facilitation/execution of the internal inspection process and ensures the Internal Audit Program across the Abbott Diagnostic business Sites/Commercial Affiliate Sites serves to identify Quality System improvements.
Independently conducts assigned audits of Suppliers and Third Party Manufacturers (TPM) to assess compliance to all applicable external standards and regulations as well as Abbott Quality System requirements at a standard commensurate with regulatory external audits.
Main responsibilities.
Plans and conducts internal audits across the Abbott Diagnostic business Sites/Commercial Affiliate Sites to assess compliance to all applicable External Standards and Regulations as well as Abbott Quality System requirements.
Identifies compliance risks to current regulations and guides the sites in the planning and execution of Quality System improvements.
Prepares and implements Internal Audit schedules spanning the Abbott Diagnostic business manufacturing sites, Commercial Affiliate sites, as well as the scheduling and performance of Supplier / TPM audits.
Uses current regulatory trends to identify potential compliance risks or opportunities for improvement in the Abbott Diagnostic business Quality System.
Conducts internal audits at a standard commensurate with regulatory external audits.
Leads initiatives to address compliance gaps across the Commercial Affiliate Sites.
This may include the development of CAPA plans and resulting follow-up guidance activities in support of the Commercial Affiliates to attain the required level of compliance.
Reports progress of audits within Sites and to Division personnel as appropriate.
Provides guidance to applicable “Inspection-Readiness” activities across the Abbott Diagnostic business Sites.
Performs topic specific SIM audits at the Abbott Diagnostic business sites as requested by management.
Reports audit findings in a timely manner.
Generates and reports internal audit metrics to Site and Division Management.
Maintains files and documentation associated with internal and external inspections.
Participates as subject matter expert (SME) in audits; provides compliant, and strategic solutions to complex quality issues.
Leads projects that are cross-functional in scope; directly influences project direction and scope; champions new initiatives and acts as the catalyst for change within and potentially across Divisions.
Maintains and demonstrates an understanding of global standards, regulations and regulatory bodies.
Your profile.
Degree preferably in science or technical discipline such as biology, chemistry, engineering or certification in Medical Technology or Quality Management.
Minimum 5 years in pharmaceutical or medical device industry or other regulated industry.
Working knowledge of Good Manufacturing Practices (GMPs), Quality System standards and regulatory requirements such as 21 CFR CFR Part 600, ISO , and IVDD etc.
Trained in auditing techniques; Certified Auditor qualification or equivalent is preferred.
Knowledge/background in In-Vitro Diagnostics (IVD) is an advantage.
Fluent in English, additional German language skills are preferred.
The role requires travel during a typical year at a rate of up to 75%.
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.
Abbott is an Equal Opportunity Employer, committed to employee diversity.
We ask for your understanding that we only consider online applications via our online application portal.
Applications by email or post cannot be processed.
Original documents will not be returned.
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The base pay for this position is N/A In specific locations, the pay range may vary from the range posted.
FAMILIA DE TRABAJO Operations Quality DIVISION CRLB Core Lab UBICACION Germany > Wiesbaden-Delkenheim.
G20 UBICACIONES ADICIONALES TURNO DE TRABAJO Standard VIAJES Yes, 75 % of the Time VIGILANCIA MEDICA Not Applicable ACTIVIDADES LABORALES SIGNIFICATIVAS Not Applicable Abbott significa el poder de la salud.
Durante más de 125 años, Abbott ha ayudado a las personas a alcanzar todo su potencial, porque el mejorar la salud permite a las personas y a las comunidades alcanzar mucho más.
Con una red mundial diversa que brinda servicios a clientes en más de 160 países, creamos nuevas soluciones en todos los ámbitos de la salud, a nivel mundial y en todas las etapas de la vida.
Ya sea que se trate de diagnósticos de última generación, dispositivos que cambian la vida, nutrición basada en la ciencia o reformulaciones innovadoras, proponemos algunas de las tecnologías más innovadoras y revolucionarias para el cuidado de la salud, y así ayudamos a las personas a vivir al máximo su vida gracias a una mejor salud.
Los empleados de Abbott vienen a trabajar todos los días con incansable energía y entusiasmo, y con la promesa de mejorar la salud y el bienestar de millones de personas.
Traspasan las barreras para ayudar a manejar y a tratar algunos de los desafíos de salud más grandes de la vida.
Te invitamos a explorar las oportunidades en Abbott, a evaluar si tu talento y expectativas profesionales coinciden con los puestos que tenemos vacantes.
Como empleador que brinda empleo sobre la base de la igualdad de oportunidades, Abbott acoge y promueve la diversidad en la fuerza laboral.
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