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:

1. 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
2. Driving the development of the global Bioprocess Quality and RA strategy as well as targets
3. Establishment and development of the Customer/Case Management process
4. 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
5. Leading, developing the global Bioprocess quality team incl. all related budget responsibilities

Quality Management

1. 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
2. Being the representative of the Bioprocess Quality Department towards external Authority inspections and client audits (Management Representative acc. to 13485)
3. Proactively provides leadership in Bioprocess Quality System definition and deployment with focus on prevention, continuous improvement programs, and customer satisfaction
4. Provide quality and process related training
5. Conduct internal functional/organizational Audits as well to interfaces like Sales & Service organization, Competence Center and supplier, distributor
6. Establish and monitor KPI performance including data collection and providing reports to the management

Complaint Management

1. Establishment and development of the Customer/Case Management process
2. As Complaint Management process owner monitor the uniformity of the complaint management process and analyze the effectiveness and identify improvement opportunities
3. Prepare reporting for internal review meetings (create reports, pattern search, trend identification)
4. 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
5. Support in the design and implementation of the company-wide data management strategy in Customer Complaint Management

CAPA Management

1. As process owner of Non-Conformance Process establish and monitor a Bioprocess Eppendorf group wide harmonized process
2. Build-up competence of resources within Bioprocess that reasonable and effective executes CAPA, NC
3. 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
4. Provide tracking reports for NC, CAPA and Corporate Complaint Investigations

Regulatory Affairs

1. Provide regulatory input to new product development and product lifecycle planning for our Bioprocess products
2. 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)
3. Compile, prepare, review and submit regulatory submissions to authorities in cooperation with local country/Regional Regulatory Affairs colleagues
4. Anticipate regulatory obstacles and emerging issues throughout the product lifecycle
5. Monitor validity of licenses, registrations and listings and renew in time
6. 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

1. Manage efficiently and motivate cross-functional and intercultural teams (direct and indirect reports)
2. Establish individual goals and expected levels of performance, evaluate performance, give feedback and provide people development measures (e.g. training, coaching) where needed
3. 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
4. Initiate and realize the change process (behavior, mindset), being a role model

Your expertise

1. Deep knowledge in Q-Systems ISO 9001, 13485, GMP, beneficial experiences with UD FDA 21 CFR Part 820 Quality Systems Regulation
2. At least 10 years of experience in the Life Science or Medical Device industry
3. Many years of experience in the design and implementation of QM systems and business processes
4. Degree in engineering in natural sciences or comparable technical education
5. Fluent in German and English
6. Life science/ Medical device Industry experience
7. Strong interpersonal skills, ability to collaborate and network effectively

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