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, 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.
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As the Senior Manager of the 24/7 FLQA Team, you will report to the Head of Front Line QA at the Holly Springs, NC Facility. Benefits Include Outdoor Amenities, Onsite Café, Medical, Dental, Vision, Life Insurance, 401K with a 6% match, and PTO available from your first day of hire. You will be responsible for 24x7 quality team oversight on the front line/shop floor including providing technical or compliance guidance, responses:
- Review batch specific documentation and data to ensure compliance with requirements defined processes and all relevant cGMP regulatory requirements including batch record review, logbook review, AQL, line clearance, alarm response, etc.
- Maintain and promote a cGMP compliant culture, ensuring that the highest standards of quality, housekeeping, and safety are applied within all GMP areas across the Holly Springs site, through QA walk-throughs and presence and quality oversight on the operations floor.
- Help develop SOPs, batch records, and supplemental documents, ensuring that the most current process and standards are being performed.
- Provide 24/7 FLQA coverage across the Holly Springs site.
- Ensure compliant use of Quality Systems such as Veeva, GLIMS, etc.
- Represent Quality during regulatory inspections, internal audits, self-inspections, and customer audits.
- Ensure team is prepared to support during inspections, conducting tours, as an SME, or on the inspections team.
- Drive teams to ensure comprehensive inspection responses corrective actions.
- Ensure areas of oversight are always inspection ready.
Be a primary Quality partner to Operations:
- Provide technical advice and expertise and support decision-making on any important topics or issues that arise.
- Drive strategy and direction as the Quality Assurance contact in the respective leadership forums
In collaboration with their counterparts in FLQA, and the Head of FLQA, provides strategy and direction to the FLQA team.
- Ensure the strategic deployment of FLQA, ensuring risk-based QA oversight over all cGMP manufacturing operations.
- Promote and maintain a cGMP-compliant culture, ensuring that the highest standards of quality, housekeeping, and safety are applied within all cGMP areas across the site, through QA walk-throughs and presence on the operations floor.
- Provide QA support for projects and activities relating to all cGMP operations on site.
- Build and manage a collaborative, team of quality professionals by defining expectations, driving individual accountability, managing prioritization/workload allocation, recognizing accomplishments, managing performance, and ensuring professional development.
- Ensure staffing, training, and development of team to support the needs of the operational facility.
- Acquires, maintains, and shares knowledge of current local and international regulatory and legislative requirements and trends to ensure that advice and appropriate technical support on all quality/compliance related matters are provided to the site.
Qualifications:
- Degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry); advanced degree preferred
- 7+ years' experience in quality/GMP in the pharmaceutical/biotech industry
- 3+ years' leadership/team management experience
- Experience within a global matrix organization
- Experience in project management and business/QA systems
- Knowledge of appropriate regulatory requirements including GMP/GQP
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
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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 what's available to you as a CSL Seqirus employee.
About CSL Seqirus
CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about CSL Seqirus.
We want CSL Seqirus to reflect the world around us
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL Seqirus.
Do work that matters at CSL Seqirus!
Watch our 'On the Front Line' video to learn more about CSL Seqirus