Senior Manager/ Associate Director (gn) Quality Assurance GCP
At MorphoSys, our ambition is to redefine how cancer is treated. As a global, commercial-stage biopharmaceutical company, we are driven by the urgency to discover, develop, and deliver groundbreaking medicines, aspiring to give more life for people with cancer.
Our success is created by our people and we bring together exceptional talent from around the world. We are an equal opportunity employer and take pride in offering our colleagues an open, flexible, and diverse work environment. We are looking for people who share our values and are motivated to improve the lives of people impacted by cancer.
Our headquarters are in Planegg, Germany and our U.S. operations are anchored in Boston, Massachusetts. To learn more, visit us at www.MorphoSys.com, and follow us on Twitter and LinkedIn.
We would like to fill the following vacancy as soon as possible:
Mission of Quality Assurance is to achieve excellence in auditing, quality management, quality risk assessment and enhance quality mindset for the benefit of our patients.
The job holder for this role is responsible for managing business relationships with defined stakeholder groups and senior leaders in Development / Clinical Functions for the strategic development and delivery of a GXP risk based robust quality assurance program and quality management activities for these stakeholders. Additionally, the job holder is responsible for delivery of proactive end‐to‐end GXP inspection support and management as well as managing and improving effective audit programs and perform audits.
Our success is created by our people and we bring together exceptional talent from around the world. We are an equal opportunity employer and take pride in offering our colleagues an open, flexible, and diverse work environment. We are looking for people who share our values and are motivated to improve the lives of people impacted by cancer.
Our headquarters are in Planegg, Germany and our U.S. operations are anchored in Boston, Massachusetts. To learn more, visit us at www.MorphoSys.com, and follow us on Twitter and LinkedIn.
We would like to fill the following vacancy as soon as possible:
Mission of Quality Assurance is to achieve excellence in auditing, quality management, quality risk assessment and enhance quality mindset for the benefit of our patients.
The job holder for this role is responsible for managing business relationships with defined stakeholder groups and senior leaders in Development / Clinical Functions for the strategic development and delivery of a GXP risk based robust quality assurance program and quality management activities for these stakeholders. Additionally, the job holder is responsible for delivery of proactive end‐to‐end GXP inspection support and management as well as managing and improving effective audit programs and perform audits.
Your Responsibilities:
- Leading and / or providing oversight to major regulatory inspections and provision of expert advice to Senior Managers on emerging regulatory issues
- Actively leading or contributing to the strategic direction for a risk-based assurance program
- Leading, planning and conducting audits in GCP / GVP areas
- Working with contract personnel or consultants to prepare, conduct and report outsourced audits within GCP / GVP
- Managing business relationships with stakeholder groups and senior leaders
- Leading or participating in the investigation of critical quality issues and ensure timely reporting of issues to relevant authorities
- Oversight of significant CAPAs for clinical activities
- Support and continuous improvement of the QM system related to GCP / GVP
- Accountable for providing expertise / consultations on GXP related issues to internal company Stakeholders / Departments as well as representing QA in interactions with Vendors
- Support Vendor Selection activities as assigned
- Primary contact partner for advice to GCP relevant departments for creation of SOPs
- Conduct of internal trainings related to GCP as required
- Contributing to functional budget management
Job Qualifications:
- University degree in biology, chemistry, medicine or related discipline or degree in area related to clinical development
- Ideally 8+ years professional experience in the area of clinical quality assurance / quality management including system and study audits at e.g. CROs, clinical trial sites
- Fluent in English
- Expert knowledge in the area of GCP and GVP preferably in national and international regulations
- Excellent Team Player and strong personality
We offer:
- Creative working in X-functional teams
- Acting as a change leader
- Open and appreciative corporate culture
- Multicultural environment
- Working in an attractive, high-quality equipped building with restaurant
- Free sports and language courses
- Simplified application for people from Ukraine (fast track via LinkedIn Profile); additional relocation package
Thank you for your interest! We are looking forward to receiving your pertinent application documents. For your application please use exclusively our career portal. We offer not only excellent career prospects, but also support you from the very beginning – even helping you move if necessary.
MorphoSys AG, Semmelweisstraße 7, 82152 Planegg
MorphoSys AG, Semmelweisstraße 7, 82152 Planegg