Quality and Regulatory Compliance Auditor (x|f|m) - Hybrid

Sartorius

1d • Hybrid

About The Position

Within the Regulatory Affairs and Compliance department, we are looking to fill immediately on a 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 programm across all relevant sites, specialist input towards the regulatory affairs team and processes requiring governmental or other relevant external compliance related communications and approvals, including the filing of necessary applications and handling all required interactions. The goal is to ensure regulatory requirements are fulfilled in comprehensive manner within the business unit and so to shape the future with us The job is to be filled full-time and is performed remotely on some days as well as on site. Grow with us – Your 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

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

Responsibilities

• writing and reviewing governing procedures to ensure a compliant and effective quality system
• support continuous process improvement efforts
• perform or maintain risk assessments for all compliance‑related elements
• ensure that products and processes remain audit‑ready
• ensure that all regulatory and business unit operational requirements within the quality management system are consistently fulfilled
• contribute essential quality and compliance expertise to both internal initiatives and externally sponsored projects
• coordinate responses to observations and take part in resolving deviations, change records, and incidents
• keep relevant databases up to date to ensure accuracy, completeness, and compliance
• support 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
• help create optimal strategies and support teams in making informed decisions
• stay alert to new or upcoming regulations and collaborate with the appropriate teams to implement suitable regulatory strategies within the quality management system
• interact with global regulatory authorities and external consultants
• train, mentor, and supervise team members, consultants, and contractors

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level