QC Manager

Do you want to work with a company that tackles fascinating problems and find solutions to complex challenges 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 were 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 peoples lives. Its a feeling of possibility creativity and purpose that inspires us every day.

The QC Manager will be reporting to the Head of QC. You will work onsite at our CSL Seqirus in Holly Springs NC location. Our benefits include an Onsite Café 1/2 mile Walking Trail Basketball and Tennis Courts; access to Medical Dental Vision Life Insurance 401K with a 6% match and an annual bonus; and accrued PTO wellness days and floating holidays.

Responsibilities

This position is for a member of the Quality Control (QC) team in Holly Springs Influenza Vaccine manufacturing facility supporting their specific laboratory. The position provides front line support from a compliance and technical perspective related to their department to ensure services provided to the customers are accurate and patient safety is maintained.

The role will be fundamentally compliance related and includes overseeing the QC Logistics team and the group of Compliance Specialists who own deviations for the department managing CAPAs document revisions providing guidance related to equipment/work orders and ensuring compliance within the group.

• Oversees daily operations of the Logistics and Compliance teams ensuring alignment with established procedures and performance expectations.
• Ensures timely completion of SAP Work Orders across the entire QC department.
• Tracks and manages Periodic Reviews in Veeva to uphold compliance with review timelines and ensure accurate updates.
• Oversees the change control process internal self-inspections and Health Authority (HA) inspections. Monitors all TrackWise and Veeva workflows (including Deviations Change Controls CAPAs and Product Complaints) to ensure records progress efficiently and meet internal deadlines.
• Leads the response process for both formal and informal auditor inquiries ensuring timely and thorough communication.
• Aligns team objectives with site-wide quality performance measures and strategic goals.
• Conducts regular performance reviews provides mentorship and develops tailored growth plans for direct reports.
• Actively participates in succession planning identifies high-potential talent and fosters team development.
• Leads recurring operational meetings and ensures COS-related sessions (e.g. PCTs QA/QC huddles) are held consistently and meet SMS/COS requirements.
• Tracks and reports key performance indicators (KPIs) and project statuses for both teams driving accountability and continuous improvement.
• Delivers clear engaging presentations to internal teams and cross-functional groups including contributions to LQMR (Local Quality Management Review).
• Liaises with non-Quality Control business units such as QA Validation AST MST etc to ensure cross-functional support is obtained when trying to meet objectives.
• Communicates campaign-impacting information up the organizational structure and ensures investigations are completed on time and with relevant information.

Minimum Qualifications

• Bachelors degree or equivalent required. Degree in a science discipline preferred.
• 7 years related industry experience required
• Direct experience with regulated environments (i.e. cGMP OSHA EPA) is required.
• Basic knowledge of cGMP and FDA requirements preferred.
• Experience with Laboratory Systems and Investigation/Deviation/CAPA writing.
• Excellent organizational planning and time management skills.
• Strong oral written and interpersonal communication skills. Demonstrated technical writing skills.
• The ability to work effectively in both a team environment and an individual contributor role.

Our Benefits

CSL Seqirus employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL Seqirus offers resources and benefits from health care to financial protection so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family need help paying for emergency back up care or summer camp looking for mental health resources planning for your financial future or supporting your favorite charity with a matching contribution CSL Seqirus has many benefits to help achieve your goals.

Please take the time to review our benefits site to see whats available to you as a CSL Seqirus employee.

About CSL Seqirus

CSL Seqirus is part ofCSL. As one of the largest influenza vaccine providers in the world CSL Seqirusis a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S. the U.K. and Australia CSL Seqirus utilizes egg cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.

We want CSL Seqirus to reflect the world around us

At CSL Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy we are able to better understand and connect with our patients and donors foster strong relationships with our stakeholders and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging CSL.

Do work that matters at CSL Seqirus!

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