Job Information
Sartorius Head of Quality & Regulatory Affairs BPS (x|f|m) in United States
We are currently seeking a Head of Quality & Regulatory Affairs BPS (x|f|m) for the our BPS division. In this position you will be a member of the BPS Operations leadership team and will interact closely with the Head of quality LPS as well as the Quality management ATS to ensure achievement of quality and operational priorities in alignment with divisional business and ATS business objectives.
Grow with us – Your Responsibilities
Provide strategic direction for the pragmatic harmonisation of quality management systems, including electronic systems, across the global BPS network of empowered sites to ensure consistent high standards
Manage and develop local quality leadership, ensuring adherence to industry standards, regulatory requirements, and company policies
Provide guidance to BPS quality teams and manage projects related on global initiatives to meet divisional level quality objectives
Stay abreast of international regulatory requirements and ensure compliance
Develop and maintain relationships with regulatory agencies, ensuring timely submissions and approvals for products/services
Work closely with sales and marketing to translate quality expertise and regulatory support to establish differentiated leadership proposition in the market and ensure highest customer service level
Monitor and assess internal and external quality standards, leading continuous improvement initiatives in alignment with LPS and ATS Quality
Develop and implement strategy for regional and global collaboration across the BPS quality and regulatory organisation for value-adding contributions to the overall customer experience as well as the productivity and scalability of the BPS
Implement and monitor EHS programs across BPS, (product safety compliance) to create and maintain a safe working environment, together with legal, to ensure product compliance and supply in all territories
Support the global BPS Operations leadership, in managing the development, maintenance, and adherence to global and local business continuity plans for transparent, risk mitigated business operations
What will convince us
Master’s degree in a relevant life-science or engineering field
A minimum of ten years industry experience and proven experience as Head of Quality (x|f|m) or similar leadership role from regulated ISO, Medical device or GMP regulated Industry
In-depth knowledge of international quality standards (ISO and cGMP) and regulatory requirements
Deep familiarity with all quality functions including quality control, quality assurances, validation, regulatory affairs, and EHS
Outstanding communication and negotiation skills
Excellent organizational and leadership skills in a global organization
Analytical mind with high personal initiative and strong ability to motivate self and others
Fluent in English
What we offer
As a growing global life science company , stock listed on the DAX and TecDAX, Sartorius offers a wide range of benefits:
Personal and Professional Development: Mentoring, leadership programs, Talent Talks, LinkedIn Learning, internal seminar offerings , coaching for managers
Work life balance: Remote options, flextime, flexible work schedules, sabbaticals
Attractive compensation
Large, modern campus: O pen 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
Travel benefits: C ar leasing, bike leasing, large free parking garage, good bus connections
About Sartorius
Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide.
We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment.
Join our global team and become part of the solution. We are looking forward to receiving your application. www.sartorius.com/careers