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Senior Quality Manager (189786BR)

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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.

Requirements

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.

The Company Offers:
  • 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.

Contacts

Contact person:

Lina Eidikytė

E-mail:

 with subject "Senior Quality Manager (189786BR)"