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QA Manager

Celyad

Mont-Saint-Guibert, Belgium

Role & Responsibilities

  • Collaborate with Manufacturing, Quality Control and Research and Development to continually improve compliance with quality systems, internal SOPs and regulatory requirements and to resolve deviations & CAPA’s;
  • Lead or participate as required in investigation teams to resolve quality assurance issues, as necessary;
  • Lead & participate in GMP compliance audits of suppliers, contract manufacturers, contract research organizations and contract laboratories;
  • Lead & participate in GMP compliance audits of quality systems and support functions as required;
  • Lead or support Document Control related processes;
  • Support and conduct training for employees, as necessary;
  • Prepare trend reports related to in-process monitoring, deviation reports, investigation reports. Follow up with functional department for timely completion of corrective and preventive actions recommended, as necessary;
  • Serve as the QA representative on project teams;
  • Support the qualification/validation of equipment and computer based systems; support process validation studies and tech transfer as needed;
  • Work with other departments (non-clinical, clinical, and regulatory) as an active crossfunctional team member to ensure the appropriate document/data integrity for regulatory submission and preparation;
  • Support Quality Management in the development and infrastructure of the Quality function in view of product commercialization;
  • Evaluate compliance of completed Manufacturing records (batch records & forms);
  • Perform QA contract manufacturing oversight and/or contract research organizations activities to ensure required quality standards are maintained in GMP, GCP and other relevant regulations and guidelines;
  • Perform other related duties as assigned from time to time based on company needs.

Qualifications & Experience

  • Scientific Master degree in Bioengineering/Industrial Pharmacy/Biomedical Sciences, min. 10 years of relevant experience;
  • Good knowledge of GMP and GDP within the bio-pharmaceuticals environment, preferably in product development or early clinical stages;
  • Experience with regulatory inspections (including FDA);
  • People management experience;
  • Experience with Advanced Therapy Medicinal Products (ATMPs) is an advantage.

Skills & Competencies

  • Autonomous;
  • Taking the lead, being accountable;
  • Demonstrated knowledge of risk management tools;
  • Excellent organizational skills and strong attention to details;
  • Works precisely as per procedures, rules and regulations;
  • Team spirit & will to develop others;
  • Negotiation & communication skills;
  • Flexible & creative thinking;
  • Excellent English and French knowledge (oral and written).

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