Place of work:

from 1800EUR/month (The final salary depends on the amount of experience)

Contract type:

Start date:

About the role:

R&D Manager is a member of global T&I (Technology and Innovation) team with responsibility for process and product development and project management.

R&D Manager is a critical function for project execution and team management of T&I work streams. The T&I Manager is responsible for project management and assigned resource utilization (both in project and direct reports in T&I Team) with focus on maintaining the T&I workstream flowing. R&D  Manager contributes to development of business strategy as well as all T&I processes in accordance with legislation and expectation of CvT Senior Manager Team. The function leads the individual and T&I team development.

Your key duties and responsibilities:

Internal Audit Process:

  • Execute the Internal Audit Process in the organization according to the site schedule
  • The position provides leadership, oversight, and strategic guidance for site issues related to Quality Compliance
  • Ensure that the Quality Management System is periodically evaluated and audited and appropriate CAPA is taken to meet the business and regulatory requirements
  • Ensure robust investigation of Audit Observations and adequate CAPA action plans, ensure alignment in Audit Non Conformance Ratings
  • Liaise with Site Leaders on assessing gaps and defining actions plans related to Internal Audit Non Conformances
  • Analyse Internal Audit data for systemic trends, drive compliance and improvement in Internal Audit Metrics
  • Gather and analyse data as an input to the Management Reviews to allow meaningful review
  • Support Internal Audit and Corporate Audits as required

External Audit Process:

  • External audit process execution, from readiness, to execution, response and tracking of commitments
  • Provides leadership, oversight, and strategic guidance for companywide issues related to Quality compliance
  • Liaise with Quality Leaders on assessing gaps and defining actions plans related to External Audit Non-Conformances, reviewing and approving responses to Notified Body/Health Authorities as applicable
  • Gather and analyse data as an input to the Management Reviews and/or CAPA Review Board

Compliance and Education Program:

  • Contribute to the development of Corporate training materials to execute the Internal Audit Program and compliance education trainings (QSR, ISO, GMPs)
  • Coach/train internal auditors
  • Keep abreast of all current regulatory and statutory expectations
  • Support Regulation/Standard Gap Assessments and implementation as required

Inspection readiness:

  • Enable successful product realization and compliance through readiness compliance activities, assessments, and other consultation
  • Ensure sites are in permanent state of inspection readiness using readiness tools
  • Support coordination of responses to Notified Bodies to ensure SME and Management engagement and buy-in
  • Performs and lead Gemba walks as part of readiness activities

Health Authority:

  • Support External Audits and responses

Other responsibilities:

  • Support other projects as required by the business


About you:

  • Internal Lead Auditor Certification and experience in executing audits
  • Excellent written and verbal communication skills, with an open, collaborative, interactive leadership style
  • Ability to build and nurture strong and positive relationships with other leaders to partner effectively
  • Balanced technical understanding of products and processes combined with business and compliance acumen


Education / Qualifications:

  • Minimum of B.S., or equivalent, in a scientific/technical discipline is required
  • Five to Ten (5-10) years in the medical device and/or pharmaceutical industry preferred. We welcome candidates also from other regulated industries
  • Two to Four (2-4) years’ experience in a QA/QC role
  • Practical experience and global mastery in global quality standards and regulations governing medical products.
  • Communicative level of English language


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