Director Corporate Quality Compliance (f/m/d)

82319 Starnberg (Stadt), 82319 Starnberg
30.10.2019

Daten dieser Anzeige

Job-ID: 011505373
Director Corporate Quality Compliance (f/m/d)

Aenova Group

Germany

recruiting@aenova-group.com

Continuous development and harmonization of company guidelines (manual, guidelines, process documents, etc.) according to various standards (cGMP and HACCP) and legislations (national, European, US FDA) in coordination with the QA managers in the plants and with the management Establishment and implementation of new guidelines and regulations in the internal system on the basis of official, legal and customer requirements with regard to GMP Exchange and harmonization of superior Quality Procedures / Processes (Best Practice) Negotiation and approval of group-wide quality agreements with key customers Quality Key Contact for defined key account customers within the Aenova Group, including participation in BRM´s and product-related, cross-departmental project groups Identification and analysis of quality problems as well as introduction of solutions and preventive measures to reduce costs Support in the preparation and active participation in international official inspections (FDA, ANVISA, etc.) at the various sites Regular organization and implementation of quality conferences with the local QP´s and the heads of Quality / QA within the Group

Director Corporate Quality Compliance (f/m/d) for our headquarters in Starnberg, Germany   With a planned turnover of around EUR 750 million in the current financial year, the Aenova Group is one of the leading companies in the global pharmaceutical and healthcare industry. The group's portfolio of services covers the entire value chain for the development and production of all the main dosage forms and product groups in the field of medicines and dietary supplements. The Aenova Group's high standards of quality, innovative technologies and clear vision for the future have enabled it to become European market leader in the business-to-business field. The company, which has its headquarters near Munich, operates 22 sites in ten countries throughout the world. More than 4300 employees contribute to the group's success. What can you expect? Continuous development and harmonization of company guidelines (manual, guidelines, process documents, etc.) according to various standards (cGMP and HACCP) and legislations (national, European, US FDA) in coordination with the QA managers in the plants and with the management Establishment and implementation of new guidelines and regulations in the internal system on the basis of official, legal and customer requirements with regard to GMP Exchange and harmonization of superior Quality Procedures / Processes (Best Practice) Negotiation and approval of group-wide quality agreements with key customers Quality Key Contact for defined key account customers within the Aenova Group, including participation in BRM´s and product-related, cross-departmental project groups Identification and analysis of quality problems as well as introduction of solutions and preventive measures to reduce costs Reporting on quality status and escalating quality problems Carrying out regular self-inspections and Mock FDA inspections within the Aenova Group Support in the preparation and active participation in international official inspections (FDA, ANVISA, etc.) at the various sites Regular organization and implementation of quality conferences with the local QP´s and the heads of Quality / QA within the Group Training of pharmaceutical personnel   What should you bring? BSc / BA in Natural Sciences or comparable education Proven experience as Qualified Person according to §14/§15 AMG and several years of professional experience in a leading position in the pharmaceutical industry (quality control / quality assurance, production and / or development) as well as sound cGMP knowledge are advantageous Proven experience in organizational and process optimization, outsourcing opportunities, cost savings, with international customer audits / authority inspections (FDA / ANVISA, etc.) Excellent understanding of cGMP and QP obligations, manufacturing of pharmaceuticals, packaging of finished pharmaceuticals and market introduction Experience in Business Process Management and Project Management High self-motivation to make a difference in the area of pharmaceutical compliance Safe handling of MS Office products Excellent attention to detail and ability to analyze and solve complex problems Exceptional analytical, conceptual and problem-solving abilities in combination with a high degree of communication- and team skills Fluent in German and English   What we offer? We offer a growth-oriented, dynamic and international environment, which offers challenging tasks  across the sites as well as active participation opportunities. If these tasks in a future-proof corporate group attract you, then we would like to get in touch with you.   Have we inspired your curiosity? Please submit your complete application documents stating your salary expectations, the period of notice and the reference code STA 2019.042 preferably by email to recruiting@aenova-group.com. For any questions please contact the human resources department at +49 8151 9987 116. Aenova Group, Aenova Holding GmbH, Personalabteilung, Berger Str. 8-10, 82319 Starnberg Members of the Aenova Group C.P.M. o Dragenopharm o Haupt Pharma o Swiss Caps o SwissCo o Temmler www.aenova-group.com  

Pharma, Chemie, Med.-/ Biotechnologie

Projekt- und Produktmanagement/ Qualitätsmanagement

Unternehmensführung/ Management

Chemie/ Pharma/ Biotechnologie

Gesundheits-/ Sozialwesen/ Medizin

Bereichs-/ Abteilungs-/ Gruppenleitung

Vollzeit

82319 Starnberg (Stadt)

82319 Starnberg