Site Change Coordinator

Location
Libertyville, IL, US
Posted
Aug 24, 2020
Ref
5040
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 Site Change Coordinator will provide critical quality expertise to support and ensure consistency and implementation of the change request process (including proposals, tracking, and compliance of all components) end to end. The Site Change Coordinator will ensure timely implementation of changes in compliance with regulatory and cGMP requirements. The Site Change Coordinator is responsible for making quality decisions and resolving issues based on experience and written procedures, providing process development/improvements and facilitating effective cross-functional communication to key stakeholders, escalating as needed.

Responsibilities
  • Accountable for the on-site and inter-functional evaluation and implementation phases of change requests. Set priorities for change requests at site level, in line with relevant boards. Key contact for proposed CCR at site.
  • Establish and support on site project teams to ensure project management to the agreed strategy and timelines.
  • Ensure efficient, timely, and clear communication to all involved stakeholders as required for project execution in collaboration with project leader and teams. Highlight and escalate issues.
  • Communicate progress and deviations as appropriate. Provide Management with weekly/monthly reflecting status of all requested activities.
  • Support training and development of on-site personnel with regards to knowledge and understanding of site related Change Control Processes.
  • Responsible for ensuring the compliance of the Change Control process documentation to cGMP, company policies and procedures; author/update/approve SOPs, FORMs, etc. in documentation management system.
  • Manage CCRs in identified system to align with company timelines.
  • Support process experts in evaluation, planning and execution through closure in system.
  • Partner with other functional business units including but not limited to manufacturing and validation to resolve issues.
  • Communicate activity status and issues effectively and promptly to all levels of the organization, as well as other departments such as Supply Chain and Manufacturing.
  • Support of other quality systems to include, but not limited to, batch issuance, batch disposition status changes, audit and quality management review, change control, document management, and non-conformances.

Qualifications
  • Minimum B.S. degree; life sciences background or emphasis preferred.
  • Must have comprehension of Change Control processes.
  • A minimum of 5 years of experience in pharmaceutical industry with manufacturing based GMP operations (preferred), including direct experience in Quality Assurance.
  • Experience with viral gene therapies and/or orphan disease indications is a plus.
  • Excellent oral and written communication
  • Ability to synthesize data and summarize outcomes to provide recommendations on compliant path forward; ideal applicant will be required to demonstrate high attention to detail, multi-tasking, and organization ability.
  • Proficiency in and knowledge of MS Office, deviation and CAPA management software, and document management systems.
  • Must have a strong knowledge and application of the CFR's and cGMP's.


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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