Careers

Quality Assurance Manager

Job Description

JOB TITLE                                           Quality Assurance Manager

REPORTING TO                                 Vice President, Regulatory Affairs and Quality Management

DEPARTMENT/FUNCTION               Regulatory Affairs

PLACE OF WORK                               Geneva, Switzerland

TYPE OF CONTRACT                        Permanent

 

The Quality Assurance Manager guarantees the efficiency and appropriateness of the ObsEva activities, in compliance with the applicable requirements, by implementing and maintaining an integrated Quality, Process and Risk Management System.


KEY TASKS & RESPONSIBILITIES

  • Maintain and improve an efficient Quality Management System
    • Keeping Quality Manual up to date
    • Ensuring Quality Document periodic reviews and update
    • Retirement and archival of obsolete Quality Documents
    • Keeping the current approved versions of Quality Documents accessible to ObsEva's personnel
  • Audit Plan Management
    • Audit Plan preparation at the beginning of the year
    • Update of the Plan through the year and preparation of closure of the Plan at the end of the year.
    • Yearly summary of the audit data.
    • Act as connection point between ObsEva's and the auditors.
    • Participation in audits performed by external auditors
    • Independent execution of GMP and GCP audits as required
    • Review of external audit reports and CAPAS
    • Preparation of reports and CAPAS for autonomous executed audits
    • Follow up on audit observations and CAPA plans with auditors and auditees
  • Ensure that ObsEva personnel is trained on internal procedures and policies
    • Onboard training of new personnel
    • Training of personnel on new versions of SOPs
  • Third Parties Quality Management
    • Review and co-signature of Quality Agreements with Third Parties
    • Qualification of Third Parties
    • Monitoring of Third Parties Quality Performance
  • Guarantee of the compliance of the conduct of clinical trials and also the compliance of the clinical trial documentation with applicable regulation and requirements, with potential support of external experts
  • Set-up of an appropriate regulatory intelligence process. Support on Quality topics to ObsEva's stakeholders as required


PROFESSIONAL SKILLS & EXPERIENCE

  • 5 to 10 years of experience in Quality Management
  • Experience in small to medium size pharma company 
  • Strong knowledge of applicable standards: applicable quality standards and appropriate clinical trial regulations and guidelines
  • Excellent computer skills.

 

PERSONAL SKILLS & COMPETENCIES

  • Good team player and ability to work in functional matrix organization
  • Excellent communication, negotiation and interpersonal skills
  • Organized, rigorous, reliable, rapid and precise
  • Self-starter, pro-active and high sense of initiative
  • Strong ethics and creativity
  • Flexible, mature and able to work under pressure
  • Willing and able to travel (mainly Europe), as needed.

 

EDUCATION/LANGUAGES

  • Degree in Health or Life Sciences, or equivalent
  • Complete fluency in English is a must

 

Should your profile match the above requirements, and you are willing to join a passionate and committed team, please apply online using the following link: Quality Assurance Manager

We will only reply to applications in line with the above requirements.


In line with its culture, ObsEva is committed to ensuring full confidentiality in the treatment of all received data.