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Novartis Gene Therapies Associate Director, Global Compliance GMP in Libertyville, Illinois

Overview

Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? Since 2013, Novartis Gene Therapies (formerly AveXis) has had one focus: bringing change to those devastated by genetic diseases.

The Novartis Gene Therapies culture embraces this mission. As a compassionate and dedicated team, we are enthusiastic about the science behind our work and finding answers to difficult questions. We are dedicated to communities affected by rare diseases, and these patients and families are the motivation for everything we do.

We have built a team with exceptional depth of experience, unified by a common vision; to develop gene therapies with the potential to positively impact the lives of the patients and families devastated by rare and life-threatening neurological genetic diseases. Though we are proud of what we have achieved to date, we remain relentlessly focused on making that vision a reality.

The Associate Director, Global Compliance GMP, supports the globalization of the compliance program, based on prioritization and risk, across GMP operations worldwide. This role reports to the Director, Global Compliance GMP GDP.

Responsibilities

  • Act as an expert resource for sites that self-identify potential risks or request solutions for potential compliance issues.

  • Contribute significantly to site inspection preparation, management and response process. Ensure that corrective actions to inspection observations are propagated through the organization and lead lessons learned exercises to support continuous improvement.

  • Contribute to a monthly Global Quality Management Review meeting (QMR) to review compliance metrics, ensure a state of control and drive action where appropriate along with reporting on a specific set of quality and compliance metrics.

  • Support management of the Escalation process, ensuring reporting and closure timelines.

  • Contribute to execution of the Quality Plan and continuous improvements efforts.

  • Support development and deployment of Global GxP compliance procedures and standards for optimized efficiency and effectiveness, meeting all appropriate compliance requirements worldwide and optimally supporting and enabling strategic goals.

  • Work with the Quality Systems teams to contribute to developing robust quality systems, including both implementation and operation at all sites, including:

  • SOPs/Document Management: Approve instruction sets, specifications, instructions and other Quality Assurance procedures directly related to GXP activities.

  • Deviation/CAPA Management: Ensure all deviations from established procedures are appropriately documented and investigated to determine and fix root cause and CAPAs are executed appropriately.

  • Training: Ensure all personnel, including contractors, consultants and temporary employees have the proper qualifications, skill sets, education, and training to perform their job in accordance with applicable procedures and regulations.

  • Contribute to assurance of data integrity.

  • Other related job duties as assigned.

Qualifications

  • Bachelor's degree in Microbiology, Chemistry, Biochemistry or related relevant field with 10 years of experience in bio pharmaceutical based GMP operations and 5 years in a leadership role.

  • Experience with viral gene therapies and/or orphan disease indications is a plus.

  • Comprehensive knowledge of FDA and EU regulations and experience in US and international regulatory agency inspections.

  • Direct experience in GMP auditing, supplier auditing, and Health Authority inspection management including preparation of responses and corrective action plans.

  • Excellent oral and written communication skills with strong technical writing experience.

  • Experience working with sites to improve performance and mitigate risks.

  • Ability to synthesize data and summarize outcomes to provide recommendations on compliant path forward.

  • Demonstrated ability to perform long-term project planning, team building, budgeting and operational excellence.

  • Approximately 50% travel.

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.

Novartis Gene Therapies 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. #LI-MG1

Job Locations US-IL-Libertyville

Posted Date 2 weeks ago (11/12/2020 2:47 PM)

Job ID 2020-5792

# of Openings 1

Category Quality

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