Quality Consultant, Leiden

QC Consultant - Contractor (project - 6 months), Leiden We are a biotechnology company with operations in Europe and the U.S. dedicated to developing transformational medicines for more years of life and quality of life. We are in the business of changing lives. Focusing on high unmet medical needs, we synergize compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class small molecules, CAR-T therapies and biologics in oncology and immunology. With capabilities from lab to patient, including a decentralized CAR-T manufacturing network, we are committed to challenging the status quo and delivering results for our patients, employees and shareholders.Scope of the role: We are seeking a highly motivated QC consultant to join the EU Quality Control team located in Leiden, The Netherlands. The EU QC team is mainly responsible for method transfer, training, and SME support to our decentralized manufacturing units (DMUs). Furthermore, the team is involved in the overall strategy on scaling our decentralized network, ensuring compliant and efficient processes to strengthen and enhance our model.In this role, the QC consultant will be hands-on with QC SME support of clinical runs, quality record management, implementation of Changes, CAPAs and procedural updates and be a back-up for training of methods. Responsibilities Clinical runs support as QC SME (troubleshooting and QC review) Quality record management (Deviation, CAPAs and Change controls)Write and review documentation related to the QC EU Review and approve procedures Function as back-up for QC training if needed Collaborate cross-functionally to ensure that the processes are aligned and communicated Ensure improvements that are designed and implemented are compliant while keeping simple and efficientJob requirements Who are you? BSc/MSc in life sciences, biotechnology, or related discipline Around 5-years’ experience in QC in the pharmaceutical / biotech industry Experience with quality record management and root-cause investigation Experience with various analytical techniques such as Flow Cytometry, PCR and cell-based assays is preferredStrong knowledge of GMP guidelines Strong interpersonal, verbal and written communication skills Ability to be flexible with changing priorities Self-driven and can-do mindset Combination of conceptual thinking with pragmatic approach to implementation Fluent in English and ability to travel What's in it for you?We prioritize your continuous growth and development, fostering a culture of empowerment. Our employees are the driving force behind our mission to lead in pharmaceutical research and innovation. We offer a competitive compensation package and a supportive work environment with strong focus on your health and well-being. Join us in our journey towards sustainability, as we strive to make a lasting impact on both the industry and the planet.We are dedicated to ensuring equal employment opportunities. Our hiring decisions are based on merit, considering qualifications, skills, performance, and achievements. We strictly prohibit discrimination against any employee or job applicant based on personal characteristics that are unrelated to their job.

#J-18808-Ljbffr