Darbo aprašymas

Position summary:

The role is responsible for ensuring compliance, manage KPIs and improvements to Quality Management Systems across the Molecular Biology BU sites in Biosciences Division (BID) , part of our Life Sciences Solutions Group (LSG).

Roles and functions:

• Partners with Regulatory Assurance team to identify applicable QMS requirements for diverse product portfolios across MolBio BU sites.
• Manages to ensure QMS processes are updated in compliance with applicable regulations and standards (ICH, 21 CFR 211, MDR, IVDR, 21 CFR 820, ISO 9001, and ISO 13485).
• Manages to strengthen and harmonize key Quality Systems processes across MolBio sites (Management Review, Change Control, Complaint management, CAPA).
• Shares audit results and best practices to drive proactive change within all MolBio BU sites.
• Monitors all reports of non-compliance resulting from customer, registrar and regulatory audits to ensure corrective action plans are in place
• Monitors Quality KPI’s to ensure its meeting defined goals
• Manages to ensure review boards for key QMS processes are implemented and fully operational across all MolBio Bu sites.
• Manages to ensure new products are introduced meeting all regulator, QMS and customers requirements (NPI PAC meetings).
• Manages to ensure all sites follow Leader Standard Work on communication - Regulatory inspections & notified body audits are communicated upon notification, daily status updates are provided, and final closure.
• Manages to ensure that agreements are created and sustained and responsibilities are properly defined between MolBio BU sites and customers.
• Manages to ensure that training resources are available for MolBio sites QA personnel and personnel is trained to applicable regulations: MDR, IVDR, 21 CFR 820, 21 CFR part 11, and standards: ISO 13485, ISO 9001.
• Ensures information impacting QMS processes is cascaded appropriately throughout MolBio BU Leadership team.
• Ensures Management is informed in a timely manner of changes / trends in the Quality Management System regulations and standards impacting MolBio BU.

Reikalavimai

Skills and Abilities

• Well organized and structured.
• Previous management-level experience required - experienced in managing through others in a matrix organization.
• Ability to effectively lead, manage, train and motivate a diverse, multicultural group of employees.
• Ability to communicate effectively, both verbally and in writing, with a wide variety of internal and external customers.
• Ability to use some or all of the following PC applications: Word, Excel, PowerPoint.

Qualifications

• Minimum 5 years’ experience with multi-site Quality Systems management.
• Global quality experience.
• Working experience with ISO 13485 and compliance with Medical Devices or Pharmaceutical products (ICH, 21 CFR 211, MDR, FDA 21 CFR Part 820).
• Bachelor’s degree in related field, or consideration of an equivalent combination of education and experience.
• Lead Auditor Certification (ISO 13485) preferred.

Įmonė siūlo

• Meaningful, mission-based work;


• The innovative environment of the rapidly growing international company;


• High performing, driven and supportive working culture and outstanding development possibilities to increase your potential;


• An exciting opportunity to be part of a dynamic global organization and work with experienced professionals.


• Professional career opportunities;


• Monthly salary 3800-5800 Eur (Brutto) and additional benefits package.