Head of Global Quality Management & Regulatory Affairs Bioprocess (m/w/d)

Your challenges

• The Head of Global Quality Management and Regulatory Affairs Bioprocess is responsible for the strategic and operational Bioprocess Quality Management System and regulatory compliance, including:

  • Ensure and further develop compliance regarding ISO 9001, 13485, GMP and potentially US FDA 21 CFR Part 820 of the company in the QM matrix

  • Driving the development of the global Bioprocess Quality and RA strategy as well as targets

  • Establishment and development of the Customer/Case Management process

  • Managing the Bioprocess Quality Manager and Regulatory Affairs Manager in the respective area of responsibility including direct and indirect responsibility for employees which will operate within a matrix environment

  • Leading, developing the global Bioprocess quality team incl. all related budget responsibilities

• Quality Management

  • Responsible for implementing and maintaining the effectiveness of the quality management system according to ISO 9001, 13485, GMP and US FDA 21 CFR Part 820 Quality Systems Regulation

  • Being the representative of the Bioprocess Quality Department towards external Authority inspections and client audits (Management Representative acc. to 13485)

  • Proactively provides leadership in Bioprocess Quality System definition and deployment with focus on prevention, continuous improvement programs, and customer satisfaction

  • Provide quality and process related training

  • Conduct internal functional/organizational Audits as well to interfaces like Sales & Service organization, Competence Center and supplier, distributor

  • Establish and monitor KPI performance including data collection and providing reports to the management

• Complaint Management

  • Establishment and development of the Customer/Case Management process

  • As Complaint Management process owner monitor the uniformity of the complaint management process and analyze the effectiveness and identify improvement opportunities

  • Prepare reporting for internal review meetings (create reports, pattern search, trend identification)

  • Work closely with the Product Management, Production and Service teams to prioritize and answer the most important questions where our product and service performance will have impact to our customers

  • Support in the design and implementation of the company-wide data management strategy in Customer Complaint Management

• CAPA Management

  • As process owner of Non-Conformance Process establish and monitor a Bioprocess Eppendorf group wide harmonized process

  • Build-up competence of resources within Bioprocess that reasonable and effective executes CAPA, NC

  • Ensure timely and compliant execution of corporate NCs, CAPAs by driving cross-collaboration across functions, monitoring progress, and elevating issues in a timely manner for resolution

  • Provide tracking reports for NC, CAPA and Corporate Complaint Investigations

• Regulatory Affairs

  • Provide regulatory input to new product development and product lifecycle planning for our Bioprocess products

  • Develop multi-country regulatory strategies with regard to the customer target market, which is based on the requirements of internationally recognized quality standards of pharma/biotech (GMP)

  • Compile, prepare, review and submit regulatory submissions to authorities in cooperation with local country/Regional Regulatory Affairs colleagues

  • Anticipate regulatory obstacles and emerging issues throughout the product lifecycle

  • Monitor validity of licenses, registrations and listings and renew in time

  • Drive the development and improvement of Regulatory processes and procedures and in the harmonization of processes within the Global Bioprocess QM/RA group

• Leadership/people management

  • Manage efficiently and motivate cross-functional and intercultural teams (direct and indirect reports)

  • Establish individual goals and expected levels of performance, evaluate performance, give feedback and provide people development measures (e.g. training, coaching) where needed

  • Support all Human Resources processes and procedures to ensure compliant and engaged region, participate in developing compensation and people development plans in line with the company strategy

  • Initiate and realize the change process (behaviour, mindset), being a role model

Your expertise

• Deep knowledge in Q-Systems ISO 9001, 13485, GMP, beneficial experiences with US FDA 21 CFR Part 820 Quality Systems Regulation

• At least 10 years of experience in the Life Science or Medical Device industry

• Many years of experience in the design and implementation of QM systems and business processes

• Degree in engineering in natural sciences or comparable technical education

• Fluent in German and English

• Life science/ Medical device Industry experience

• Strong interpersonal skills, ability to collaborate and network effectively