Laboratory Manager - Medical Devices

PROJECTUS; Lyon; Sur place; EUR 50 000 - 70 000; Plein temps

Résumé du poste

PROJECTUS is seeking a Laboratory Manager in Lyon, France to oversee laboratory activities and ensure compliance. The role involves managing a team of 5-10 people and collaborating with various stakeholders in a dynamic environment.

The ideal candidate will have at least 5 years of laboratory management experience, a Life Science degree (preferably in Microbiology), and strong knowledge of regulatory standards like ISO 13485 and FDA QSR. Excellent leadership and communication skills are essential.

Qualifications

• Minimum 5 years of experience in laboratory management.
• Experience in cleanroom environments.
• Strong knowledge of audit processes and quality tools.

Responsabilités

• Manage laboratory activities and ensure compliance onsite.
• Monitor regulatory changes affecting laboratory operations.
• Manage departmental budgets, KPIs, staffing, and operational priorities.
• Lead a team of 5-10 people through performance management.
• Coordinate with regulatory authorities and external laboratories.

Connaissances

Leadership skills

Communication skills

Problem-solving abilities

Stakeholder management

Formation

Life Science Degree (Microbiology preferred)

Outils

ISO 13485

FDA QSR

GMP standards

Description du poste

Salary and bonus: available upon application

Projectus are exclusively representing our global Medical Device partner, who are on the lookout for their next Laboratory Manager.

With consistently new projects coming onto site and huge investment, we are on the lookout for someone who can handle change, lead a team of around 5-10 people and work with various stakeholder groups.

Are you this person? Please read on…..

KEY ACCOUNTABILITIES

• Manage laboratory activities and ensure compliance onsite.
• Monitor regulatory changes affecting laboratory operations.
• Manage departmental budgets, KPIs, staffing, and operational priorities.
• Manage a team of 5-10 people, lead and develop through performance management, recruitment, training and coaching.
• Collaborate cross-functionally with Production, Supply Chain, R&D, and Process teams.
• Coordinate with regulatory authorities, notified bodies, and external laboratories.
• Represent during absence of the Site Quality & Regulatory Compliance Director

SKILLS/EXPERIENCE REQUIRED

• Life Science Degree background (ideally from Microbiology)
• Experienced in Cleanroom environments & clean lines
• Multiyear experience within laboratory management (at least 5+ years’).
• Strong knowledge of:
• • ISO 13485, MDR, FDA QSR, ISO 14971
  • Sterilization, biocompatibility, GMP and analytical laboratory standards
  • Audit processes and quality tools
• Must come from a people management background i.e. strong leadership, decision making and problem solving abilities
• Communication and stakeholder management skills.