Specialist, Quality Assurance & Compliance

Overview

Imagine\u2026 2 weeks after the birth of your child you realize they aren't meeting critical developmental milestones and after months of doctor's appointments you are told your baby has a rare neurological disease that would impact how they would live their lives.

This is the reality of parents whose children have Spinal Muscular Atrophy (SMA) and it's the reason why we at Novartis Gene Therapy are laser focused on bringing hope and possibility to those devastated by rare genetic diseases.

We use cutting-edge technology to turn promising gene therapies into proven treatments beginning with SMA but also focusing on Rett Syndrome and Friedreich's Ataxia.

Imagine the lives you could transform by joining the Novartis Gene Therapy team.

The Specialist, Quality Assurance and Compliance, collaborates closely with Quality Control to support compliance oversight for qualification, validation and transfer and routine review of bioassay methods.

Responsibilities

• Drives 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: Ensures 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
• Oversight of testing operations in the QC laboratory, including review of testing results, as needed. Participates as a QA SME for QC analytical assays performed in the QC Lab.
• Leads data integrity review of electronic raw data against reported data.
• Participate as a leader in site inspection preparation, management and response process.
• Other related duties as assigned.

Qualifications

• B.A. or B.S. in biochemistry or relevant related scientific field with 5 years' experience in biopharmaceutical based GMP operations.
• Strong understanding of QC testing operations and provide QA oversight expertise in several QC assays, such as cell-based potency assay.
• Ability to work independently on quality oversight for lab investigations and CAPA.
• Strong knowledge and application of the CFR's and cGMP's and participate in all internal and external audits in support of the product launch.
• Experience with viral gene therapies and/or orphan disease indications is a plus.
• Knowledge of FDA and EU regulations and experience in US and international regulatory agency inspections, preferred.
• Direct experience reviewing and/or authoring standard operating procedures and partnering with operations on product related investigations and deviations.
• Excellent oral and written communication skills with strong technical writing experience required.
• Ability to synthesize data and summarize outcomes to provide recommendations on compliant path forward.

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

Why Novartis?

769 million lives were touched by Novartis medicines in 2020, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!

Novartis Gene Therapies Benefit Summary:

Annual bonus, long term incentive, health insurance, paid vacation/holidays, potential flexible working arrangements (based on role) and an employee recognition program are available for this position, among many other benefits provided to employees of Novartis Gene Therapies.

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