Manager, Quality Assurance - 4th Shift

The Opportunity

Manage one shift of Quality Assurance professionals who provide floor support to manufacturing, laboratories, utilities, maintenance, and logistics. Manages daily workload, performance management and development of direct reports. Additionally, leads quality decision making on shift and ensures maintenance of quality systems. Provides technical support for the US Holly Springs site to ensure cGMP compliance with consideration to regulatory requirements, the Quality Manual, and site SOPs. 

4th shift HOURS:

7AM – 7PM Sat – Mon,

12PM-4PM Tuesday

The Role

Successfully manage a staff of QA Specialists (exempt level professional employees) to ensure adequate coverage of shift workload. Includes the following:

• Recruitment of staff including reviewing resumes, and interviewing candidates
• Oversight of team’s training plans and ensuring team’s maintain training compliance.
• Real time coaching of staff to hold team accountable to performance expectations and the company values.
• Professional development of staff to cultivate highly talented personnel.
• Document and deliver performance reviews to staff with clear messaging.
• Consistently focuses on improving team cohesion on shift and across the quality organization.

Successfully manage the required workload on shift by performing the following:

• Provide clear allocation of daily workload and prioritize tasks throughout the shift to meet site demands.
• Ensure appropriate and consistent 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.
• Ensures collaboration of the FLQA team with other functions and departments to provide timely response to issues arising on shift.
• Delegate activities related to review and approval of workload in electronic enterprise systems – Trackwise, Veeva, Documentum, etc.

Single point of contact on shift for assessing and influencing quality issues arising throughout multiple areas of business:

• Influences other leaders across multiple departments including manufacturing, quality laboratories, utilities, maintenance and warehouse.
• Knowledgeable in multiple departments of the business as well as knowledge and expertise in each quality system across site.
• Ensures appropriate documentation of non-conforming events and any real time corrective actions taken during shift.
• Collaborates with other departments to properly assess, segregate and control product as required for any potential batch impacting issues identified.
• Ensures appropriate escalation and communication of the status of non-conforming issues arising on shift to required stakeholders.

As needed to support team workload, performs the following FLQA core tasks:

• 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.

Your skills and experience

• Bachelor’s degree in related engineering or scientific field required.
• Minimum of 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.
• Strong technical understanding of the production processes used in the pharmaceutical/biotechnology industry.
• Strong knowledge and comfort with Microsoft Office software such as Office, Word, Excel
• Strong communication skills

Benefits: Medical, Dental, Vision, Life Insurance, 401K, and PTO available from your first day of hire.

Our Benefits

Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join Seqirus.

Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus.

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus.