Senior Clinical Quality Auditor performing internal audits, analyzing results, and collaborating with clinical operations teams at DaVita. Assisting leadership with daily operations of the Clinical Quality Auditing team.
About the role
- Quality and Regulatory Compliance Auditor managing BPS operations quality audit programs across various locations in Germany, France, or the UK. Collaborating with teams to ensure compliance with regulations and standards.
Responsibilities
- In this position you take an active role in writing and reviewing governing procedures to ensure a compliant and effective quality system for the relevant site or process within the business unit
- In your day‑to‑day work, you support continuous process improvement efforts and perform or maintain risk assessments for all compliance‑related elements to ensure that products and processes remain audit‑ready across the Sartorius business entities
- You make sure that all regulatory and business unit operational requirements within the quality management system are consistently fulfilled, including staff training records, personnel files, master schedules, and the tracking of deviations
- By reviewing protocols and reports, you contribute essential quality and compliance expertise to both internal initiatives and externally sponsored projects
- Working closely with colleagues, you help coordinate responses to observations and take part in resolving deviations, change records, and incidents
- You keep relevant databases up to date to ensure accuracy, completeness, and compliance
- As part of your responsibilities, you support the Regulatory Affairs team by preparing, reviewing, editing, and submitting required documentation to the appropriate authorities
- You develop, manage, and implement operating documents, guidelines, and shared work practices, contributing your expertise as a subject matter expert
- For assigned projects, you help create optimal strategies and support teams in making informed decisions
- You stay alert to new or upcoming regulations and collaborate with the appropriate teams to implement suitable regulatory strategies within the quality management system
- When needed, you interact with global regulatory authorities and external consultants, offering guidance to colleagues in providing regulatory compliance advice to multidisciplinary teams
- You train, mentor, and supervise team members, consultants, and contractors, contributing to the growth and development of the entire team
Requirements
- You have a successfully completed Master's degree in a relevant scientific discipline, e.g. Biotechnology, Bioprocess Engineering, Chemistry or comparable
- First years of experience at supervisory level in regulated environment e.g. medical device | biotechnology industry
- Competence and qualifications for the quality and regulatory elements for medical device and ISO related certifications
- Proven ability to work effectively and collaboratively in cross-functional and international teams
- Experience with notified bodies and auditing processes
- Qualification to act as an auditor in medical device manufacturing industry
- Deep knowledge in interpretation of regulations, guidelines, policy statements, etc. and in interfacing with relevant regulatory authorities
- Expertise in the preparation of major regulatory submissions and understanding of applicable regulations
- Strong interpersonal skills and the ability to effectively dealing with a variety of personnel of different areas and hierarchies
- Advanced organizational skills, including the ability to prioritize the own such as direct reports’ workload
- Business fluent in German and English (oral and written) as well as willingness to travel (approx. 20%)
Benefits
- Personal and Professional Development: Mentoring, leadership programs, Talent Talks, internal seminar offerings, coaching for managers
- Work life balance: Remote options, flextime, flexible work schedules, sabbaticals
- Attractive compensation: Vacation and holiday bonuses including pension benefits with a 35 hr. week, 30 vacation days
- Large, modern campus: Open office spaces, terraces, company restaurant with vegetarian and vegan options, cozy Italian bistro with ice cream sales, fitness studio and daycare center
- Making an impact right from the start: Comprehensive onboarding, including a virtual online platform even before joining, Welcome Workshops, "buddy" as point of contact
- Welcoming Culture: Mutual support, teamspirit and international collaboration; communities on numerous topics, such as coaching, agile working and business women network
- We support diversity and inclusion and welcome applications from people of all nationalities, genders, sexual orientations, religions, ages, disabilities and cultural backgrounds.
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