Manager, QC (Compliance, Stability & Logistics) at Seqirus

Posted in Other 8 days ago.

Location: holly springs, North Carolina

Job Description:

Come join a company that tackles fascinating problems and find solutions to complex challenges. With deep expertise in influenza science, our team works on cutting-edge research, pioneering technologies to optimise the manufacturing process and improve the effectiveness of influenza vaccines. We operate as one integrated global organisation, drawing together expert staff from different countries to collaborate. Together, we are working on the front line to protect communities from seasonal influenza and global pandemic threats. When you join Seqirus, you join a team dedicated to making a difference in people's lives. It's a feeling of possibility, creativity, and purpose that inspires us every day.

Job Purpose:

Provide leadership to the Quality Control teams responsible for QC Compliance, Stability, GLIMs, Logistics and Sample management. Individual will recruit and develop resources to ensure full cGMP compliance. The role includes review and preparation of regulatory filing sections, review and oversight of QC investigations, change controls, and relevant document revisions. This individual is responsible for the team's timely completion of activities as well as budget oversight. This individual will provide strategic and technical knowledge to ensure all relevant cGMP requirements are met and the team is supported for development and growth.

Major Accountabilities:

  • Management of employees

  • Ensure adequate resources are available to complete key tasks on time and in full

  • Provide coaching and development of team to ensure attrition rates remain low

  • Ensure team lead coordinate's time, resources, and schedules

  • Ensure training of staff is appropriate and completed to yield a high level of competence

  • Set, monitor and evaluate goals and performance

  • Manage KPI's and metrics

  • Ensure on-time completion of work including timely closure of investigations

  • Maintain and improve cGMP compliance

  • Maintain compliance with legal regulations on occupational safety and health

  • Implement and maintain laboratory policies and procedures as necessary

  • Drive lean laboratory operation, 5S laboratory layout, preventive action & continuous improvement programs to reduce operating costs

Minimum Qualifications:

  • BS degree in Microbiology, Virology, Chemistry, Biochemistry, Biology or other related scientific field.

  • Minimum of 5 years directly relevant industry experience required, 8+ years preferred.

  • Prior supervisor/management experience required.

  • Advanced knowledge of stability programs for pharmaceuticals or vaccines preferred.

  • Advanced knowledge of Quality Systems preferred.

  • Statistical knowledge, Investigational technical writing skills and LIMS experience a plus.

  • Advanced knowledge of GMPs, safety regulations and data integrity.

Watch our 'On the Front Line' video to learn more about Seqirus