Quality Assurance Associate

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 Quality Assurance Associate is responsible for implementing and maintaining robust Quality Systems for a new viral gene therapy manufacturing site. This person will be responsible for the strategic compliance to written procedures including but not limited to: regulatory adherence and audit support, raw material qualification, specifications, supplier management, internal assessment processes, quality management review, annual product quality review (APQR), incoming release of materials and monitoring compliance with all requirements of good manufacturing practice.

The Quality Assurance Associate will provide expertise to transition a novel gene therapy into a commercially approved product. This individual must have a strong knowledge and application of the CFR's and cGMP's. Experience with regulatory inspections, self inspections, and external audits is a plus.

Responsibilities

• Provide strategic quality input on the translation of commercial product requirements into a technical product profile that includes defining critical quality attributes (CQA's) and critical processing parameters (CPP's).
• SOPs/Document Management: Approve all instruction sets, specifications, instructions and other Quality Assurance procedures directly related to incoming quality /operations and other cGMP activities.
• Deviation/CAPA Management: Ensure all deviations from established procedures are appropriately documented and investigated to determine and fix root cause.
• Vendor Management/Raw Material Release: Ensure all required assessment is carried out to support Quality approval or rejection, as appropriate, for starting materials, packaging materials, intermediates, bulk and finished product.
• Responsible for handling of complaints at the site level.
• Participate in self inspection program for the manufacturing facility. Manage findings, responses and corrections.
• Responsible for data integrity review of electronic raw data against the reported data as needed to support raw material releases.
• Participate in Site inspection preparation and response process for regulatory agencies.
• Coordinate completion of Annual Product Quality Review (APQR) reports for the marketed products
• Create monthly Quality Management Review meeting (QMR) to review site metrics, ensure a state of control and drive action where appropriate along with reporting on a specific set of quality and compliance metrics.

Qualifications

• Minimum B.S. degree in preferably microbiology, chemistry or biochemistry.
• A minimum of 3-5 years of experience in biopharmaceutical based GMP manufacturing operations is preferred.
• 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.
• 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.

Approximately 10% travel required.

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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