QA Manager

At Mind Capture you are not just starting a new role. You are joining a community that invests in your development and gives you the opportunity to grow in a meaningful technical career within healthcare.

You can count on:

• A competitive salary with a full benefits package including meal vouchers, eco vouchers, health insurance, group insurance, net expense allowance and a company car with charging or fuel card
• Personal growth support with tailored training and clear career development
• A stable environment where your technical skills directly contribute to improved patient care
• The chance to work with high tech diagnostic systems at top tier healthcare institutions
• A warm and collaborative culture focused on trust, ownership and long term impact

Take ownership of quality assurance leadership within a regulated biopharma setting.

Our client is seeking an experienced QA Manager to coordinate quality activities across laboratory testing, outsourced manufacturing and quality systems. You will lead the QA team, maintain compliance with current GMP requirements and support inspection readiness. The role may also include Qualified Person responsibilities for investigational medicinal products when the required qualifications are present.

• Team leadership:
  Allocate resources, set priorities, plan activities and evaluate QA personnel
• Quality systems:
  Implement, maintain and continuously improve a compliant Quality Management System
• Compliance oversight:
  Ensure activities follow current GMP requirements, procedures, specifications and quality agreements
• Audit management:
  Lead vendor qualification, internal audits, external audits and authority inspections
• Quality review:
  Organise annual management reviews, monitor quality indicators and oversee corrective actions
• Laboratory oversight:
  Review and approve methods, specifications, validations, protocols, reports and certificates
• Quality records:
  Review deviations, change controls, corrective actions and atypical laboratory results
• Validation oversight:
  Approve equipment qualification and computerised system validation documentation
• Training governance:
  Establish GMP training systems, training plans and performance indicators
• Inspection readiness:
  Support regulatory inspection preparation and ensure findings are addressed effectively

• Education:
  
  Master’s degree in pharmaceutical sciences, bioengineering, biomedical sciences or a related discipline
• Quality experience:
  At least ten years of QA management experience within a GMP regulated pharmaceutical or biotechnology environment
• Laboratory oversight:
  At least five years overseeing quality control laboratory activities, preferably involving biological products
• People management:
  At least five years of experience leading and developing teams
• Regulatory knowledge:
  Strong knowledge of current GMP, European Pharmacopoeia, United States Pharmacopeia, ICH, WHO and relevant United States regulations
• Inspection experience:
  Participation in health authority inspections, preferably involving European and United States authorities
• Communication:
  Strong written and verbal communication, planning and organisational skills
• Languages:
  
  Fluent written and spoken English with knowledge of Dutch
• Leadership:
  Demonstrated ability to motivate teams, share expertise and support organisational development
• Additional expertise:
  Experience with process performance qualification and biological licence submissions is a plus