Senior Manager – QA Operations

Our client in the biopharmaceuticals sector is looking for a Senior Manager – QA Operations to support the cGMP manufacturing operations for manufacture of clinical biopharmaceutical products.

Responsibilities

  • You will manage all activities of the QA Batch Release and Deviations/CAPA organizations
  • You will interact directly and facilitate communications with clients regarding product quality-related events
  • You will ensure patient safety and regulatory compliance while supporting product lifecycle activities for punctual delivery of products to clients for patients
  • You will give general direction to Quality Supervisors and Managers supporting master and executed batch record reviews/approvals for commercial programs, shop floor QA oversight, and the Deviation/CAPA system
  • You will make sure that all department and company employees comply with required procedures
  • You will provide coaching and mentoring to direct reports and QA specialists
  • You shall develop and/or support training materials for Quality Systems and give training and certification of QA personnel
  • You will ensure timelines are achieved in support of manufacturing batch release by managing workloads across the teams
  • As the Deviation/CAPA quality system owner you will provide compliant investigations, reviews and approve investigations as and when needed
  • You will issue compliant review and approval of master batch records and supporting records and procedures
  • You shall support manufacturing change controls as a QA SME, performing supplemental impact assessments and QA approvals as required
  • You will supply data for specific reports, client and internal meetings by tracking trends and compiling client specific quality metrics and internal quality metrics
  • You will attend relevant operational meetings in support of Manufacturing operations and batch disposition activities
  • You will support client audits and regulatory inspections
  • You shall provide QA Support to other departments

Requirements

  • You will be degree (Bachelor/Master/PhD) qualified with significant relevant experience in a QA or cGMP environment in Biopharmaceuticals
  • You will have experience in a similar role within the biotech sector
  • Have experience in providing QA support of Quality systems to include Deviations/CAPAs and Change Controls with supervisory experience
  • Having a solid understanding of cGMP regulations is required
  • Fluent English, spoken & written and a good level of spoken French is required

Interested? Please do not hesitate in sending your CV and/or the best contact details for yourself to info@thetechrg.com and our team of skilled consultants would be very happy to contact you with more details.

Proud to be working in partnership with Talentory AG.

To apply for this job email your details to info@thetechrg.com.