Overview

CordenPharma is a leading full-service contract development and manufacturing organization (CDMO) of active pharmaceutical ingredients (APIs), excipients and pharmaceuticals Drug Products (DP) and packaging capabilities with > 2’600 employees across the world. Our services enable pharmaceutical and biotech companies to manufacture medicines with the ultimate goal of improving people’s lives.
Our network in Europe and the US offers flexible and specialized solutions across five technology platforms: Peptides, Lipids & Carbohydrates; Injectables; Highly Potent & Oncology; and Small Molecules. We strive for excellence in supporting this network and are committed to providing the highest quality products for the well-being of patients.

To strengthen our Global team in Basel (CH) or Plankstadt between Heidelberg and Mannheim (Germany) we are looking as soon as possible for a
Global Quality Excellence Manager (m/f/d) 100 %

Plankstadt, Basel
ASAP
Full-time
Permanent

Main activities and responsibilities

Act as a Subject Matter Expert on QMS and Quality Execution Excellence across the CP network e. g. enhancement of systems / processes, quality standards
Perform internal audits and offer trainings to the sites regarding new compliance topics
Supervise CP sites on regulatory inspection readiness and inspection management, including regulatory responses and action implementation adherence.
Lead Best Practise and benchmarking activities in the CP network supporting Quality Culture and cross-functional transformation projects
Drive optimization projects to improve and harmonize compliance workflows in electronic IT applications in tight collaboration with the sites and global IT
Participate in global Quality projects with focus on continuous improvement and enhancement to the QMS integrating risk management and gap assessment principles
Moderate Quality ad-hoc boards for Escalations to Management cases rapidly after notification raised by the sites to ensure and support timely actions, effective communication (if needed) and closure of the issue
Model action plans to continually improve performance in KPIs, with specific focus on RFT and overdue compliance activities to minimize Costs of Poor Quality
Champion the visualization of regular KPI and QMR reporting in an electronic format to increase transparency and enable the build of organizational efficiencies

Your Profile

University degree or similar qualification with at least 10 years of working experience in a GxP controlled environment
In depth-knowledge of FDA- / EU-Guidelines and other relevant quality system requirements
Skills in risk management and gap assessment principles
Fluent German and English language skills
Flexibility and willingness to travel (< 20%), Internal auditor trained Confident handling in electronic systems, ideally familiarness with Trackwise, LIMS, SAP, eCTD, EDMS Excellent interpersonal and communication skills; ability to develop and maintain good working relationships and work productively with others in a team environment Highly self-motivated with «Can do» mentality and a strong sense of ownership What we offer 30 days of vacation Dynamic and exciting work environment Positive working atmosphere and open management culture with focus on continuous improvement of processes to stay innovative Free Parking Subsidy for fitness studio Home Office Interested? If you enjoy working in a team and are interested in a varied area of responsibility, if you think and act beyond your own areaof responsibility, then you should join our team. Do you require more information? In case of questions to your application, the position or something else I am very happy to support you. Raphael Brandt Global HR Business Partner E-Mail: bewerbung.cpi@cordenpharma.com APPLY NOW Corden Pharma GmbH Otto-Hahn-Strasse | 68723 Plankstadt Corden Pharma International GmbH https://files.relaxx.center/kcenter-google-postings/kc-16016/logo_google.png 2023-06-24T06:07:00.601Z FULL_TIME EUR YEAR null 2023-05-25 Plankstadt 68723 Otto-Hahn-Straße 49.4056226 8.5783011 bei Heidelberg 69115 49.4035106 8.681388 Mannheim 68159 49.49200020000001 8.455677999999999 Basel 4410 Eichenweg 1 47.4913588 7.7270673

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