AdresAre you ready to play a pivotal role in ensuring the highest standards of quality and compliance in early and late phase oncology studies?
Join us in Oss as an Associate Director Clinical Quality Management and be our key player in maintaining and elevating our global standards in clinical studies. In this role, you will provide invaluable compliance and process advice to our Clinical Operations teams, driving quality improvements on a worldwide scale.
You will be at the forefront of developing and communicating high-quality standards. As our quality compass, you'll collaborate with a passionate and collaborative team to ensure the delivery of tomorrow's groundbreaking medicines in Haematology.
What will you be doing?
As our Associate Director Clinical Quality Management, you will collaborate with a passionate group of professionals to uphold our commitment to excellence. You will be responsible for maintaining, enhancing, as well as communicating high-quality standards throughout the clinical study delivery process. Key responsibilities include:
• Collaborate effectively with colleagues and stakeholders to champion quality across R&D.
• Drive strategic focus on quality for the Haematology portfolio.
• Ensure adherence to GCP and Clinical Operations Quality objectives.
• Provide first-line quality advice to Study Management Operations and Program Management.
• Drive a culture of quality in Clinical Operations, striving for an 'always inspection ready' mindset.
• Support study/program level activities during Regulatory Inspection Support Team (RIST) events.
• Provide insights from quality metrics analysis for continuous performance improvement.
• Facilitate quality review meetings with Clinical Operations leadership team.
• Collaborate with other quality functions in the Clinical Operations Quality Network for sustainable issue resolutions.
• Continually seek opportunities for improvement and feedback, fostering a culture of knowledge sharing and learning.
What do you bring:
• Degree in life sciences or equivalent discipline.
• Demonstrable experience in clinical compliance or quality-related position.
• In-depth knowledge of drug development process and GXP activities.
• Understanding of skills required for successful clinical study delivery. Experience with Oncology and/or Haematology studies is an advantage.
• Excellent knowledge of international regulations and guidelines.
• Strong analytical, problem-solving, negotiation, and conflict resolution skills.
• Outstanding interpersonal and communication skills with influence capabilities.
• Ability to multitask and work efficiently and independently under pressure.
• Fluency in English.
What do we offer you?
• A dynamic, innovative and international working environment. You are part of the development process of new drugs that can make a difference in the lives of cancer patients and their loved ones.
• The opportunity to further develop yourself, for example, into a position offering even more responsibility. International growth (within AstraZeneca) is also one of the possibilities.
• Good primary & secondary benefits including 8% holiday allowance, 25 holidays on a full-time basis plus office closure between X-mas and New Year + Good Friday.
• Collective pension with a fixed percentage personal contribution, bonus scheme.
• Personal budget which can be used for vitality, home office equipment, sustainability or personal development.
• Access to internal training and learning and development offerings.
• You can partly work from home (2 days per week on a full time base).
Expats (already living in the EU)
• For expat candidates from the EU we offer a good relocation package (including support for an application to the tax authorities for the 30% tax ruling).
• For expat candidates we offer an expat program, including a language course and the opportunity to learn more about the Dutch culture.
The Team
You will work in the Clinical Operations Team in Oss which consists of >30 experienced professionals in various roles. We work closely with AstraZeneca's Haematology Clinical Operations teams in Toronto (CAN), US, UK (Cambridge) and Spain (Barcelona). The culture in Oss is informal, there is a great team spirit and a willingness to share and learn from each other. We all work for the same purpose: to develop drugs that make a difference in patients' quality of life. The team is looking forward to welcome new, experienced and inquisitive colleagues.
Acerta Pharma
At our international headquarters in Oss, the Netherlands, we are working to develop new treatment options for patients with specific types of blood cancer. Together with our colleagues of AstraZeneca in US, Canada, Spain and UK we are committed to innovative drug discovery and development, especially in the field of haematological oncology.
Acerta has received approval from both the US (FDA) and the European Regulator (EMA) for its small molecule BTK inhibitor for treatment of patients with chronic lymphocytic leukaemia (CLL). In addition, AstraZeneca and Acerta Pharma are collaborating on a large number of other innovative medicines to treat haematological malignant diseases.
Apply:
If you have any questions about this vacancy, our Recruitment Team, Caroline van Oppen, Karin Raadschelders can be reached at info@werkenbijacertapharma.nl or by phone on +31(0)85 - 047 0244.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
