Head of Quality And Regulatory Affairs

About the job

We are currently seeking a Head of Quality & Regulatory Affairs BPS (x f m) for the Quality System Compliance BPS division for our site in Goettingen, Aubagne or Royston.

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 the achievement of quality and operational priorities in alignment with divisional business and ATS business objectives.

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 consistently high standards
• Manage and develop local quality leadership, ensuring adherence to industry standards, regulatory requirements, and company policies
• Guide BPS quality teams and manage projects related to 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 propositions in the market and ensure the 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

Qualifications :

• Master’s degree in a relevant life-science or engineering field
• A minimum of ten years of industry experience and proven experience as Head of Quality (x f m) or similar leadership role from a 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 organisation
• 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, we offer 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 : Open office spaces, terraces, company restaurant with vegetarian and vegan options, cosy Italian bistro with ice cream sales, fitness studio and daycare centre
• Making an impact right from the start : Comprehensive onboarding, including a virtual online platform even before joining, Welcome Workshops, "buddy" as a point of contact
• Travel benefits : Car leasing, bike leasing, large free parking garage, good bus connections.
Vor 16 Tagen