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Quality assurance (qa) manager (m/f/d)

Münster
Festanstellung
Symbio Clinical Research GmbH
Manager
Inserat online seit: Veröffentlicht vor 5 Std.
Beschreibung

Your mission

About the Role

We are seeking an experienced Quality Assurance (QA) Manager to lead and further develop our quality and compliance framework across Europe. In this role, you will ensure adherence to GCP guidelines and applicable regulatory requirements (FDA, EMA, ICH), while overseeing our Quality Management System (QMS) and audit activities.

You will act as the central QA contact for internal stakeholders, vendors, and external auditors, and play a key role in maintaining inspection readiness across the organization.

Your Responsibilities
* Ownership and continuous development of the Quality Management System (QMS)
* Planning, conducting, and reporting of internal and external audits (e.g. vendors, investigational sites)
* Acting as QA representative during regulatory inspections and sponsor audits
* Oversight and tracking of CAPA processes through to closure
* Management of SOPs, Working Practices, and document change control
* Ensuring compliance of training and qualification documentation
* Driving continuous improvement of quality processes and systems
* Supporting company-wide quality training and awareness initiatives
* Line management and development of QA team members (as applicable)
* Responsibility for hiring, onboarding, and performance management
* Allocation of workload and ensuring timely delivery of QA activities
* Providing guidance and quality oversight across projects and stakeholders


Your profile

* Bachelor’s degree in Life Sciences, Pharmacy, or related field
* 10+ years of experience in clinical research, including 4+ years in GCP QA
* Proven experience conducting audits (e.g. vendors, sites, systems)
* Solid understanding of GCP and regulatory frameworks (FDA, EMA, ICH)
* Experience working with QMS and controlled documentation
* Prior experience in team leadership or mentoring
* Structured, independent working style with strong decision-making skills
* Fluent English (written and spoken)


What do we offer? Great Opportunities!

* Hands-on mentality from the beginning
We support you at all times in your development and collaboratively find projects that you enjoy and offer significant creative freedom.
* Flat hierarchies, an open feedback culture, and a fantastic team spirit
We emphasize a culture of informal address (Duz-Kultur) and an open-door policy! Following our motto "Stronger Together," you can expect a motivated team. We tackle challenges together!
* Welcome to our innovative work environment
Our hybrid workplace combines the best of both worlds - the flexibility of working from home and the dynamism of collaborative work in the office.
* Start-up meets Grown-up mentality
Experience the spirit of over 25 years of clinical trial expertise combined with the latest innovative trends in the industry.
* Exciting insights into clinical research
Our team consists of many long-term employees who are eager to share their expertise with you.
* Learning & Development Culture Personal and professional growth is a priority for us!
We believe that continuous learning and professional development are crucial for the individual success of our employees.
Additional Information
* Europe-based position (remote/hybrid depending on location)
* Willingness to travel to Münster approximately once per quarter, with additional travel as required to support audits
* Occasional international travel required
Are you interested? Then we look forward to receiving your meaningful application, including your salary expectations and details about the earliest possible start date! As you will be working in an English-speaking team, please submit your application documents in English.


About us

Symbio is a globally operating, specialized Clinical Research Organization (CRO) with locations in the USA and Europe. The mission is to improve the quality of life for thousands of people through innovative clinical research, prioritizing fast, transparent processes that allow patients to benefit from new treatments sooner.
Symbio values a flexible work culture that empowers dedicated team members to manage their work independently, whether from home or in an inspiring office environment. For those looking to advance their career while making a meaningful impact on people’s lives, Symbio offers an ideal opportunity.


Find more infomation on our website .

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