Senior Manager

Geneva Com; Genf; Hybrid; CHF 150,000 - 190,000; Full time

Job summary

Geneva Com seeks a Senior Manager of Quality & Regulatory Affairs to ensure regulatory and quality compliance for FIND-sponsored human subject research. The role maintains the quality management system and oversees regulatory activities within the organization.

The candidate will engage with internal and external partners, lead audits, and drive CAPA-driven quality improvements across geographies, with strong English and French communication skills.

Qualifications

• Graduate or post graduate degree in an appropriate scientific discipline.
• Min 5 years of professional experience in Regulatory Affairs (RA) and Quality Management (QM).

Responsibilities

• Leads the revision of the Clinical QMS with other FIND departments and research teams.
• Identifies QM systemic gaps and coordinates remediation with stakeholders.
• Provides expertise in ISO14155 / ISO20916 / ISO13485 to ensure study quality.
• Provides QA oversight of partners, vendors, and investigator sites for compliance.
• Oversees regulatory compliance for all products in portfolio (ISO 13485).
• Handles submissions, maintenance, and renewals of product approvals in various regions.
• Monitors regulatory requirements across target geographies and updates accordingly.
• Leads audits of partners, sites, and vendors and facilitates CAPA implementation.
• Advises on internal audits and leads some as required.
• Maintains understanding of global standards, regulations, and regulatory bodies.

Skills

Regulatory Affairs

Quality Management

QA Audits

GCP/ISO

Education

Graduate degree in science

Tools

MS Office

Job description

Administration, HR, Management, Accounting/Finance

Communications, IT, Media, Knowledge Management, Editor

Monitoring, Evaluation, Policy, Research, Analysis

Senior Manager Quality & Regulatory Affairs

Job Purpose:

The Regulatory and Quality Affairs Manager will be responsible for ensuring that all FIND sponsored Human Subject Research (HSR) is compliant with applicable regulatory and quality requirements. He/she will be responsible for updating and maintaining FIND’s quality management systems and for overseeing all regulatory activities within the organization. He/she will be responsible for engaging with internal and external partners for regulatory and quality assurance matters.

Detailed responsibilities:

• Leads the revision of the Clinical QMS, working with other FIND department and research teams for updates, improvements and new document creation.
• Identifies potential HSR level QM systemic gaps and coordinates with the appropriate stakeholder to ensure timely remediation. As appropriate, escalates issues of critical noncompliance and/or urgency for remediation to the senior management
• Provides expertise in ISO14155 / ISO20916 /ISO13485 to ensure the quality of studies conducted and sponsored by FIND.
• Provides QA support in oversight of partners, vendors, and clinical investigator sites while assessing compliance with local regulations, GCP/ISO requirements, study protocols and SOPs.
• Oversees and implements regulatory compliance for all products in portfolio (ISO 13485)
• Handles the submission, maintenance, and renewal of product approvals in various geographies
• Monitoring regulatory and legal requirements of target countries and keeping abreast with changes in requirements.
• Leads or assists with identifying non-compliances with requirements, provides suitable recommendations and facilitates ongoing quality improvements using risk-based methodology.
• Leads qualification, routine and for-cause audits of partners, investigator sites, laboratories and other vendors and collaborates with auditors and auditees to ensure appropriate implementation of Corrective and Preventive Action Plans (CAPAs)
• Advises on the need for internal audits (TMF, systems, processes, vendors, sites, computer system validation) and leads some of those as required.
• Oversees audit observations and CAPAs documentation and implementation.
• Supports interdisciplinary teams in regulatory matters.
• Maintains and demonstrates understanding of global standards, regulations, and regulatory bodies

Experience/Skills required:

Qualification and Experience:

• Graduate or post graduate degree in an appropriate scientific discipline
• Min 5 years of professional experience in Regulatory Affairs (RA) and Quality Management (QM)

Knowledge, skills, and abilities:

• Working knowledge of tools, methods, and concepts of quality assurance
• Expert knowledge of IVDR, ISO9001, ISO 15189:2022, ISO 17025:2017 and ISO 13485
• Strong attention to details
• Experience with In vitro diagnostic (IVD) medical devices is a big plus
• Genuine team player with a positive mindset and result-oriented approach
• Flexibility, "hands-on" and "can do" attitude
• Ability to work independently and without close supervision
• Excellent interpersonal and communication skills and experience in working in a multi-cultural environment
• Excellent written and oral communication skills in English and French
• Advanced computer knowledge of MS Office programs