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Senior Manager QA Site Compliance
3 months ago
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.
As the Senior Manager QA Site Compliance you will be reporting to the Sr. Director, Quality Assurance & Quality Site Head. You will be you will work onsite at our CSL Seqirus in Holly Springs, NC location Monday-Friday during primary business hours. Benefits Include flexible hours M-F, Onsite Caf, Medical, Dental, Vision, Life Insurance, 401K, and PTO available from your first day of hire.
Responsibilities:
- Build and manage a collaborative, high performing team of quality assurance professionals by clearly defining expectations, holding individuals accountable, managing prioritization/workload allocation, recognizing accomplishments, managing performance, and ensuring professional development.
- Manage the internal self-inspection program in accordance with global procedures to ensure compliance with local and global GMP expectations, regulations and requirements.
- Manage external domestic and international Regulatory Inspections including audit readiness activities, inspection preparation and logistics, communications, and post inspection deliverables.
- Manage and coordinate assigned deliverables for Local and Global Quality Management Reviews and site compliance including but not limited to the Site Quality Plan, key performance indicators, regulatory intelligence and gap assessments, and other compliance responsibilities.
- Acquires and maintains knowledge of local and international regulatory and legislative requirements for pharmaceutical current good manufacturing practices and trends, for all markets to which the site distributes product and utilize this knowledge to implement continuous improvement at the site.
Qualifications/Position Requirements:
- Degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry, Engineering); advanced degree preferred
- 7+ years' experience in GMP in the pharmaceutical/biotech industry including 1-3 years' leadership/team management experience
- Must have GMP and risk management knowledge and experience, prior experience in Quality preferred
- Demonstrated organizational skills, and experience with regulatory inspections.
- Experience operating within a global matrix organization and demonstrated ability to influence key stakeholders
- Strong project management skills with proficiency in Quality Management Systems
- Knowledge of appropriate regulatory requirements including GMP/GQP/GDP, etc.
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
#LI-Onsite
Our BenefitsCSL 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 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 usAs 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 SeqirusWatch our On the Front Line video to learn more about CSL Seqirus
