Manager, Quality Assurance - Operations Support (Batch Release & Materials Disposition)

Location
Libertyville, IL, US
Posted
Aug 23, 2020
Ref
5369
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, Quality Assurance - Operations Support, is responsible for making quality decisions and addressing or resolving issues based on experience, written procedures and analytical analysis, as well as tactical oversight of the incoming quality and batch disposition processes.

Responsibilities
  • Makes quality decisions and addresses and resolves issues based on experience, written procedures and analytical analysis.
  • Oversight of the material specification and material release processes, including all activities related to incoming material release, supplier corrective actions, regulatory audits, complaints, annual product quality review, and quality management review.
  • Leads/manages Quality Assurance Incoming Quality and Quality Assurance Batch Release by providing work direction, time approval, performance management and professional development of direct reports.
  • Manages the review and release of incoming materials to align with the manufacturing schedule and company timelines.
  • Provides strategic oversight and support of prioritization, alignment, and adherence to release schedules
  • Ensures program compliance of both incoming materials and outgoing finished materials from the manufacturing site
  • Communicates and manages disposition-related issues effectively and promptly to all levels of the organization, as well as other departments such as Supply Chain and Manufacturing.
  • 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 address root cause.
    • Requires direct input on the creation and effectiveness of Corrective and Preventive Action plans.
  • Assists 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.
  • Partners with other functional business units, including Manufacturing and MS&T, to resolve documentation and raw material specification related issues.
  • Coordinates on supplier corrective action requests and shipment of samples and initiate requests.
  • Create charts and provide tracking for key metric related to incoming quality and batch record documentation.
  • Support and participation in HA Inspections
  • Other related duties as assigned.

Qualifications
  • B.S. degree; 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.
  • Must have strong knowledge and application of the CFRs and cGMPs.
  • Expert knowledge and application of the CFRs and cGMPs and must have experience 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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