Manager, Pharmacovigilance Quality Assurance

Location
Durham, NC, US
Posted
Oct 10, 2020
Ref
5679
Hotbed
Bio NC
Required Education
Masters Degree/MBA
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, Pharmacovigilance Quality Assurance (PV QA) is responsible for activities overseeing the quality of the Novartis Gene Therapies Pharmacovigilance System. In addition, this role is responsible for 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 Commercial organization to ensure quality and compliance to the Pharmacovigilance system requirements.

Responsibilities
  • Provides critical strategic quality expertise to transition a novel gene therapy into a commercially approved product.
  • Coordinates and conducts pharmacovigilance inspection readiness activities across multiple functions,
  • Manages site inspection preparation, management and response process.
  • Works directly with the Global Patient Safety Organization as the QA representative to ensure all GPS procedures, projects or activities meet the organizations Quality requirements and standards.
  • Coordinates and implements the roll out of global quality commitments and initiatives across the PV system.
  • Serves as the quality lead to support risk assessments, supporting the identification of quality risks and appropriate mitigation plans to achieve compliant solutions.
  • Identifies and drives continuous improvement and standard practices for Quality to achieve both top performance and consistency, where appropriate, across the pharmacovigilance system.
  • Provideds direct oversight and quality approval of regulatory non-conformances / deviations investigations and CAPAs.
  • Investigates PV QA deviations and the implementation of any CAPAs to correct/prevent the deviations.
  • Supports development of the Global Quality Management System through providing direct PV Subject Matter Expertise in the review and updating of global procedures and systems.
  • Collaborates with Clinical Quality and Global Quality in the development of global quality standards.
  • Lead the development and update of SOPs and work instructions.
  • Support the development of the PV QA SharePoint pages and dashboards.
  • Other related job duties as assigned.

Qualifications
  • Bachelors' degree in a life sciences or scientific discipline with 7 years of experience working within the patient safety/ pharmacovigilance domain including quality, compliance, operations or medical safety experience or Masters/PhD/PharmD degree in life sciences or scientific discipline with 5 years of experience working within the patient safety/ pharmacovigilance domain including quality, compliance, operations or medical safety experience
  • 3 years of experience in a Quality function.
  • 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). 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.
  • Approximately 20% travel.

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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