Quality Assurance Operations Manager

Quality Assurance Operations Manager

Your new company

For our client, a global manufacturing pharmaceutical company, we are looking for a senior Quality Operations Manager, responsible for ensuring the GxP compliance of the quality processes in operational manufacturing activities at the site, to ensure products are manufactured according to established quality standards and the quality compliance of the products throughout their lifecycle.

Your new role

  • Quality representative and the main point of contact for quality topics related to production activities and products
  • Lead the QA Operations Team promoting a quality culture in line with the company's values
  • Assure production operations are executed in compliance with GxP, internal procedures and guidelines and provide expertise to support the resolution of issues.
  • Work with different stakeholders to ensure business needs are met in a compliant manner
  • Support the investigation process to ensure the timely evaluation of deviations and complaints and their escalation when needed
  • Review and approve risk assessments, change controls, deviation and compliant investigations and their associated CAPAs
  • Edit, review, approve GMP documents and internal procedures
  • Oversee the coordination and the completion of Product Quality Reviews
  • Appropriate and timely reporting of KPIs
  • Support internal, external, customer audits and assist during Health Authority Inspections as required
  • Adheres to the principles of GxP to the extent related to the performed activities, regularly train to policies

What you'll need to succeed

  • University degree in Pharmacy, Chemistry, Biology, or relevant Life Science
  • Minimum of 5 years of relevant experience in Quality Assurance within the pharmaceutical industry, with at least 2 years in a managerial position
  • Proven cross-functional project management skills
  • Strong knowledge of GMP processes and regulations, pharmaceutical quality assurance principles and regulatory requirements
  • Excellent analytical problem-solving skills
  • Leadership and team management capabilities
  • Flexibility and ability to manage competing priorities
  • Effective communication and negotiation skills
  • Collaborative, team-spirited, positive, and energetic person
  • Fluent in English and local language

What you'll get in return

  • Developing your career in a prestigious multinational Life Sciences company
  • Promoting and developing various projects for a top portfolio of products
  • Competitive salary package

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now. If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion on your career.


What you need to do now


If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.

If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion on your career.


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Sumar

Tipul locului de muncă
Permanent
Industrie
Produse farmaceutice
Oraș
Bucharest
Domeniu
Life Sciences
Referinţă
1194563
Data de incetare
31 Aug 2025

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