Quality and Regulatory Compliance Auditor; x|f|m- Hybrid

Overview

Within the Regulatory Affairs and Compliance department, we are looking to fill immediately on an unlimited basis a Quality and Regulatory Compliance Auditor (x|f|m) at the locations in Goettingen (Germany) or in Aubagne (France) or Royston (UK).

In this position you are responsible for steering and management of bioprocess solution (BPS) operations business unit level quality audit program across all relevant sites, providing specialist input to the regulatory affairs team and processes requiring governmental or other external compliance communications and approvals, including filing of necessary applications and handling all required interactions. The goal is to ensure regulatory requirements are fulfilled in a comprehensive manner within the business unit and to shape the future with us.

The job is full-time and is performed remotely on some days as well as on site.

• 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 environments (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 the 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 deal with personnel of different areas and hierarchies.

• Advanced organizational skills, including the ability to prioritize own and direct reports’ workload.

• Business fluent in German and English (oral and written) and willingness to travel (approximately 20%).

• You identify with our values Sustainability, Openness & Joy and are motivated to work in a rapidly growing company.

• Write and review governing procedures to ensure a compliant and effective quality system for the relevant site or process within the business unit.

• Support continuous process improvement efforts and perform or maintain risk assessments for all compliance-related elements to ensure products and processes remain audit-ready across the Sartorius business entities.

• Ensure that all regulatory and business unit operational requirements within the quality management system are fulfilled, including staff training records, personnel files, master schedules, and the tracking of deviations.

• Review protocols and reports to contribute essential quality and compliance expertise to internal initiatives and externally sponsored projects.

• Coordinate responses to observations and participate in resolving deviations, change records, and incidents in collaboration with colleagues.

• Keep relevant databases up to date to ensure accuracy, completeness, and compliance.

• Assist the Regulatory Affairs team by preparing, reviewing, editing, and submitting required documentation to the appropriate authorities.

• Develop, manage, and implement operating documents, guidelines, and shared work practices, contributing as a subject matter expert.

• Support assigned projects by creating optimal strategies and helping teams make informed decisions; stay alert to new or upcoming regulations and collaborate with appropriate teams to implement suitable regulatory strategies within the quality management system.

• Interact with global regulatory authorities and external consultants when needed, offering regulatory compliance guidance to multidisciplinary teams.

• Train, mentor, and supervise team members, consultants, and contractors, contributing to the growth and development of the entire team.

• Personal and Professional Development:
  Mentoring, leadership programs, Talent Talks, internal seminar offerings, coaching for managers.

• Work life…