Manager, QA

CSL•Holly Springs, NC

6d•Onsite

About The Position

Seqirus has an exciting opportunity to join our expanding team in Holly Springs, NC. With an advanced manufacturing facility and expertise in influenza science we are one of the world leaders in the production of the influenza vaccine. We operate as one integrated global company, drawing together expert staff from different countries to collaborate. Together, we're 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. You will report to the Sr. Manager, FLQA and will manage one of the day shifts of QA professionals who provide floor support to manufacturing, laboratories, utilities, maintenance, and logistics. You will manage daily workload, performance management and development of direct reports. Additionally, you will lead quality decision making on shift and ensure maintenance of quality systems and provide technical support onsite at our Holly Springs, NC site.

Requirements

Bachelor's degree or equivalent in related engineering or scientific field required.
5+ years' relevant experience within the biopharmaceutical industry with experience in biotechnology and aseptic processing
Demonstrated knowledge of GMPs and FDA requirements
2+ years Quality Assurance experience in a FDA regulated environment preferred.
2+ years of supervisory experience or demonstrated leadership role preferred.
Previous experience directly operating or supporting a Bulk/API, Formulation, Filling, or Packaging process.
Technical understanding of the production processes used in the pharmaceutical/biotechnology industry.

Responsibilities

Manage a staff of QA Specialists to ensure coverage of shift workload.
Oversight of team's training plans and ensuring team's maintain training compliance.
Coach staff to hold team accountable to performance expectations and our values.
Document and deliver performance reviews to staff with clear messaging.
Focus on improving team cohesion on shift and across the quality organization.
Manage the required workload on shift by performing the following:
Provide clear allocation of daily workload throughout the shift to meet site demands.
Ensure appropriate and information is communicated during team shift handovers.
Apply knowledge of regulatory requirements to support proper decision making as well as drive continuous improvement on site.
Ensure collaboration of the Frontline QA (FLQA) team with other functions and departments to provide response to issues arising on shift.
Delegate activities related to review and approval of workload in electronic enterprise systems – Trackwise, Veeva, Documentum, etc.
Main contact on shift for assessing and influencing quality issues arising throughout multiple areas of business:
Influence other leaders across multiple departments including manufacturing, quality laboratories, utilities, maintenance and warehouse.
Knowledgeable in multiple departments of the business and knowledgeable in each quality system across site.
Ensure appropriate documentation of non-conforming events and any real time corrective actions taken during shift.
Collaborate with other departments to assess, segregate and control product as required for any potential batch affecting issues identified.
Ensure appropriate escalation and communication of the status of non-conforming issues arising on shift to required stakeholders.
To support team workload, performs the following FLQA core tasks:
May perform approval of deviation investigation for minor to major issues as well as change control approval in electronic enterprise system
Perform review and approval of batch record and operating procedures in electronic enterprise system.
Perform real time batch record/logbook review.
Perform routine quality walkthroughs in manufacturing.
Support quality systems related to QA for in-process sampling and controls.
Provide quality oversight of site alarm reports and maintenance program.
Support regulatory inspections and site self-inspections as required