Associate Director, R&D QA

2 days ago

Seqirus USA NC Holly Springs, United States CSL Seqirus Full time
The Opportunity

Do you want to work with a company that tackles fascinating problems and find solutions to complex challenges? CSL 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.

Reporting to the Sr. Director, Product Development Quality, you will:

  • Drive the implementation of Quality Initiatives, Systems, Processes, and Quality Operations for early clinical phases (Phase I to III) for cell culture and mRNA platforms.
  • Develop Quality strategies for Phase appropriate Quality Assurance for clinical phases (Phase I to III) stage.
  • Ensuring regulatory compliance with requirements for therapeutic products manufactured for toxicology studies and clinical trials.

The Role
  • Implement R&D quality systems, policies, and procedures in line with CSL Global Quality Management System (QMS)
  • Primary representative for R&D Quality in site quality management forums and discussions
  • Develop and maintain Phase appropriate Quality systems
  • Represent R&D Quality as a senior member of the Change Control Panel
  • Provide QA disposition on R&D deviations/CAPAs and Investigations for R&D clinical trial materials and Non-Clinical Toxicological studies
  • Provide QA expertise to establish programs such as raw material receipt release and routine EM monitoring for the Holly Springs site.
  • Manage the R&D quality unit to provide change control, batch release, and deviation management functions for early clinical phases
  • Conduct internal audits of R&D functional areas as they relate to non-Clinical trial materials and clinical materials manufacture
  • Assist with 3rd Party Quality audits as required
  • Drive and implement Quality Continuous Improvement Projects
  • Develop and build strong business relationships with local and global quality sites where manufacturing operations are shared between sites
  • Develop Quality Key Indicators with key PD stakeholders to ensure the effectiveness of quality systems
  • Attend and provide Quality oversight for CPT (Core Project Teams representing Quality) for new Product Development projects as required
  • Manage performance and development of QA staff
  • Educate and inform R&D on international trends in quality and compliance in the pharmaceutical industry as they relate to biotechnology product development
  • Develop and implement a "Quality on the Floor" culture

Your skills and experience
  • Bachelor's degree in pharmacy, Chemistry, Biology, or Biochemistry; advanced degree preferred
  • 10+ years' experience in quality in the biopharmaceutical industry with 1 – 3+ years' leadership plus team management experience. Experience in commercial or clinical manufacturing is advantageous, including knowledge of phase appropriate quality systems.
  • Sound knowledge of GxP, FDA, and EMA regulations
  • Sound knowledge of pharmacopeias such as USP, EP, and other country-specific requirements
  • Experience in the application of Quality Systems
  • Previous experience managing a team of direct reports

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

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

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