Manager, Compliance

Location
Libertyville, IL, US
Posted
Aug 28, 2020
Ref
5370
Hotbed
BioMidwest
Required Education
Bachelors Degree
Position Type
Full time
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 Manager, Compliance is responsible for making quality decisions and addressing or resolving issues based on experience, written procedures and analytical analysis. This role is also responsible for the oversight of regulatory audits, complaints, annual product quality review, self-assessments, and quality management review.

Responsibilities
  • Manage Quality Assurance/ Compliance Associates by providing work direction, time approval, performance management and professional development.
  • Manage the complaint process for both clinical and commercial complaints.
  • Supports the development and implementation of robust quality systems including:
    • SOPs/Document Management: Approve all instruction sets, specifications, instructions and other Quality Assurance procedures directly related to operations and other cGMP activities.
    • Deviation/CAPA Management approval:
      • Ensure all deviations from established procedures are appropriately documented and investigated to determine and fix root cause.
      • Requires direct input on the creation and effectiveness of Corrective and Preventive Action plans.
      • Assist with implementation and supporting on-going continuous improvements.
    • 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.
  • Manage site inspection preparation, inspection logistics and execution, and response process.
  • Quality lead for inspection strategies, preparation, and interactions
  • Monitor industry observations and trends as a preventive tool to ensure compliance.
  • Develop and manage a risk management program at the site level, including management of a site quality risk register.
  • Partner with other functional business units, including Manufacturing, MS&T, and QC as needed to facilitate complaint investigations and regulatory CAPA related issues.
  • Manage the monthly Quality Management Review meeting (QMR) to review plant metrics, ensure a state of control and drive action where appropriate along with reporting on a specific set of quality and compliance metrics.
  • Manage the APQR process to ensure the annual product review is approved in the required timeframe.
  • Track any CAPAs that were identified during the APQR evaluation.
  • Manage site self-assessment program including creating and maintaining the self-assessment schedule, approving assessment reports and action plans, and tracking CAPAs.
  • Other related duties as assigned.

Qualifications
  • B.S. degree in a life sciences area; life sciences background or emphasis preferred.
  • 8 years of experience in biopharmaceutical based GMP manufacturing operations .
  • Experience with viral gene therapies and/or orphan disease indications is a plus.
  • Previous experience with supervision of teams and processes is preferred.
  • Comprehensive knowledge of FDA and EU regulations and direct experience in US and international regulatory agency inspections.
  • Direct experience reviewing and/or authoring standard operating procedures and review and approval of investigations and deviations.
  • Excellent oral and written communication skills with strong technical writing experience.
  • Experience supporting audits, identifying findings, driving resolution and providing a closure report.
  • Ability to synthesize data and summarize outcomes to provide recommendations on a compliant path forward.
  • Strong knowledge and application of the CFRs and cGMPs.
  • Expert knowledge and application of the CFRs and cGMPs and have been involved in regulatory inspections.

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.

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