Join Our Team at CSL Plasma!
At CSL Plasma, part of the CSL Behring Group, we are proud to be one of the world's largest collectors of human plasma. Our mission is to produce high-quality coagulation and immunoglobulin products that help people with rare and serious diseases lead normal, healthy lives. We believe that our success is driven by our dedicated and skilled employees—like you!—who contribute to our goals every day.
Your Opportunity
We are currently seeking a passionate and experienced Regional-Leiter Quality Center Operations (m/w/x) to join our Quality Assurance department in Germany. This is a full-time, permanent position where you will play a crucial role in ensuring the highest quality standards across our plasma centers.
Your Responsibilities
As the Regional Leader, you will:
* Oversee compliance with established quality standards at assigned plasma centers in Germany, collaborating closely with various departments (e.g., Operations, Medical, Laboratory, IT).
* Establish and implement an effective QA management system, ensuring regular communication with the Management Leadership Team and other stakeholders about safety, quality, identity, and purity of collected plasma.
* Lead and develop your team, managing organizational workflows to achieve strategic company goals, including personnel planning, recruitment, and employee development.
* Ensure "Inspection Readiness" in your area and assist in preparing for, conducting, and following up on regulatory inspections and internal audits.
* Provide "Quality Oversight" and guidance on our established quality management systems, utilizing risk-based analysis tools and process optimization methods.
* Manage the timely processing and approval of deviations and related actions, including risk assessments and QA evaluations in the change control process.
* Standardize the goods receipt and release process across all plasma center locations in collaboration with LQK centers.
* Trend and manage complaints within your area, working closely with LQK centers and material manufacturers.
* Lead and actively participate in national and international projects.
Your Qualifications
We are looking for candidates who possess:
* A degree in a scientific, medical, or quality management-related field, or equivalent training with further education and several years of professional experience.
* At least 5 years of practical experience, including 2-3 years in quality assurance and 2 years in a leadership role.
* Fluent German and English communication skills, both written and spoken.
* Knowledge of regulations (e.g., GMP guidelines, AMWHV, AMG) and a balanced understanding of regulatory cGMP and operational requirements.
* Strong leadership skills: you are a guiding force, motivating, empathetic, observant, resilient, organized, decisive, honest, fair, and reliable.
* Willingness to travel up to 40% of your working time.
* Experience in project management and familiarity with risk-based analysis tools and/or knowledge of statistical methods, Six Sigma, or similar process optimization techniques is a plus.
What We Offer
Join us for a diverse range of responsibilities within a rapidly growing international company. You can look forward to:
* Flexible working hours
* A collegial work environment in a motivated and successful team
* Competitive compensation, including a 13th-month salary and annual bonus
* 30+2 vacation days and additional perks (e.g., DB BahnCard)
Our Commitment to You
At CSL, we prioritize your well-being. We care about our employees and strive to create an inclusive and supportive workplace. Learn more about how we care at CSL.
About CSL Plasma
CSL Plasma is dedicated to ensuring that individuals with rare and serious diseases can lead fulfilling lives. Our commitment to quality and safety is unwavering because lives depend on us. Discover more about our mission and values.
Inclusion and Belonging
At CSL, we believe that diversity fuels innovation. By celebrating our differences and fostering a culture of curiosity and empathy, we can better connect with our patients and donors, build strong relationships with our stakeholders, and sustain a diverse workforce that drives our company forward. Learn more about our commitment to inclusion and belonging.
Make a Difference with CSL Plasma!
Join us in doing work that truly matters!