Associate Director, Head of Pharmacovigilance Quality Assurance

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 Associate Director, Head of Pharmacovigilance Quality Assurance (PV QA) is responsible for activities overseeing the establishment and maintenance of the quality of the Novartis Gene Therapies (GTx) Pharmacovigilance System. In this role, Head of PV QA will be responsible for leading the PV QA team, decision-making regarding quality assurance topics and for collaboration with core team members in QA, Global Patient Safety (GPS), Regulatory Affairs (RA), Medical Affairs (MA) and the GTx Commercial organization to ensure quality and compliance to the GTx Pharmacovigilance system requirements.

A successful candidate will provide critical strategic quality expertise to transition a novel gene therapy into a commercially approved product. This individual must have a strong knowledge and application of the global pharmacovigilance regulations and have been involved in multiple regulatory inspections (familiar with multiple regulatory jurisdictions both domestically and international).

Responsibilities

• Lead the establishment and development of the PV QA organization in GTx Development Quality Assurance.
• Work directly with the Global Patient Safety Organization as the QA representative to ensure all GPS procedures, projects or activities meet the GTx Quality requirements and standards.
• Coordinate and implement the roll out of global quality commitments and initiatives across the PV system.
• Represent the GTx Pharmacovigilance system requirements in Global QA boards and projects.
• Support the development of GTx Global QA functions including but not limited to DocControl, Training, Compliance, Supplier Quality, Clinical Quality and Quality Systems providing direct PV Expertise in the review, updating and establishment of global procedures and systems.
• Oversee and support all GTx audits and inspection with PV functions in scope.
• Coordinate with Clinical QA to establish and manage Bannockburn site regulatory inspections and internal audits.
• Provide direct oversight and quality approval of Pharmacovigilance non-conformances / deviations investigations and CAPAs.
• Serve as the point of escalation between the GPS team and the Global QA organization for the communications and escalation of risks or non-compliances
• Serve as the primary point of contact for GPS during audits and inspections.
• Monitor global pharmacovigilance regulatory intelligence to determine impact on GTx pharmacovigilance quality system.
• Manage PV commitments from internal audits, regulatory inspection findings, and CAPAs.
• Contribute to the PV System Master File (PSMF) to ensure it is maintained on a regular basis.
• Manage the collection, organization, and presentation of all required global GPS compliance metrics including vendor and partner oversight metrics.
• Develop methods to determine the effectiveness of GPS training and initiate improvements as required.
• Represent GPS training on cross-functional learning initiatives and partner with related departments (Learning and Development, IT, Commercial Training, etc.) accordingly.
• Remain current with global pharmacovigilance regulations and requirements, evaluate legislative changes affecting GPS, and develop strategies to support the patient safety at the local level.

Qualifications

• Bachelor's Degree or equivalent work experience in a scientific or technical discipline.
• Must have a minimum of 5-7 years of experience in pharmacovigilance. Experience in areas of GXP regulations with 3-5+ years of experience in a quality and compliance role within pharmacovigilance highly preferred.
• Quality and compliance background, preferably related to Pharmacovigilance.
• Comprehensive knowledge of FDA and EMA pharmacovigilance regulations for products in a clinical development or post-marketed setting.
• Experience in US and international regulatory agency inspections.
• Strong project management skills and ability to communicate effectively across matrix functions at all levels of the organization, influencing areas not under direct control to achieve shared objectives while balancing speed, quality and risk.
• Credible knowledge of global regulations governing Pharmacovigilance for products in clinical development and post-marketing.
• Proficient MS Office and SharePoint skills.

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.