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Manager, Research Quality Assurance

Employer
Novartis Gene Therapies
Location
San Diego, CA, US
Start date
Jul 3, 2020

View more

Discipline
Regulatory, Research/Documentation, Science/R&D
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Beach
Overview

Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission.

AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene.

The Manager, Research Quality Assurance is responsible to contribute, drive, execute and support the implementation of a robust Quality Management program for the diverse activities conducted at AveXis globally within the Research, Pre-Clinical safety and Scientific areas utilizing labs involved in clinical trials.

Responsibilities
  • Collaborates with AveXis Research to support the implementation of applicable data integrity, quality and regulatory requirements that are relevant to the fast-changing research/exploratory environment.
  • Collaborates with business partners to assess and improve internal processes and systems; monitor and review study conducts, records and reports; develop standard operating procedures for various efficacy and safety studies; identify and provide appropriate QA support and guidance to meet business and regulatory requirements while maintaining the highest scientific standards and promoting a culture of quality and compliance.
  • Drive quality by close business partnering and consensus building to positively impact the business and implement simplification and improvement initiatives in compliance with AveXis and regulatory requirements. Provide Quality support and oversight for research, preclinical and GLP/GCLP regulated activities both in-house and externally. Interact with the research team and relevant stakeholders to provide consultation on applicable quality and regulatory requirements.
  • Conduct review of research and laboratory activity documentation ( e.g. Lab Notebooks, study reports and systems) for potential data integrity and data quality gaps. Provide summarized reports on the review results, and support issue resolution and closure.
  • Monitor and assess existing research, preclinical and lab processes/systems for the identification of risks in quality and data integrity and potential impact of regulatory requirements.
  • Support the development and implementation of processes and standards for research and lab activities, including study ID/naming, protocol documentation and amendment, data management, record keeping and archiving.
  • Create standard operating procedures (SOPs) to be performed in research and preclinical studies (e.g. efficacy and safety studies in mice).
  • Observe study activities and procedures performed by the research team, collaborators or service providers to ensure that activities follow study protocol and established SOPs.
  • Participate in the review of research study reports and IND package for accuracy, completeness and data traceability.
  • Provide consultation and guidance on the use of Human Tissue for research and exploratory activities following regulatory practices.
  • Support the evaluation and risk management of external collaborators and service providers to ensure Novartis quality requirements and/or GLP standard are met.
  • Plan and execute quality project initiatives providing oversight, monitoring and proactive communication of such efforts.
  • Support and execute the communication and training program to ensure that all research associates understand relevant quality and regulatory requirements, including internal standards and processes.
  • Identify, monitor and report effective KPIs and metrics relevant to the research quality program to help identify trends, gaps and focus areas for sustained compliance and improvements.
  • Keep abreast with regulatory requirements and industry trends and assess their potential impact on AveXis.
  • Foster a quality culture and mindset within the research team and business partners.
  • Other related duties as assigned.

Qualifications
  • B.S. degree in the life sciences. A Master of Science degree is preferred.
  • 8 years of research experience within the pharmaceutical/biotech/scientific industry. Experience with gene therapy or animal studies is considered a plus.
  • Excellent oral and written English communication skills.
  • Ability to work with a wide range of business functions along with demonstrated success in a "matrix" type role.
  • Experience supporting research activities, lab operations and vendor management.
  • Demonstrated experience in risk assessment, identifying gaps and implementing action plans for quality improvement. Experience with non-GxP or GxP (GLP/GCLP) quality areas is considered a significant advantage.
  • Broad knowledge of data integrity, best scientific and documentation practice, and GLP regulations.
  • Demonstrated ability to successfully work in a cross-functional team.
  • Ability to synthesize detailed information and provide clear communication and messaging across quality, research teams and business partners.
  • A clear sense of personal accountability, an ability to empower people, ability to drive a quality culture with partners and a high degree of mutual respect and integrity are essential factors to succeed.
  • May be required to travel internationally.


The level of this position will be based on the final candidate's qualifications.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.

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