Senior Specialist, Data Integrity Quality Operations

Location
Durham, NC, US
Posted
Jan 13, 2021
Ref
5831
Hotbed
Bio NC
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 Senior Specialist, Data Integrity Quality Operations responsibilities are to identify, analyze, and evaluate potential Data Integrity risks throughout the full data lifecycle in processes and systems across the organization.

Responsibilities
  • Performs Data Lifecycle Pathway Mappings to identify potential Data Integrity risks, and work with cross-functional stakeholders to define the corrective and preventative measures (CAPAs) and related mitigation of risks.
  • Facilitates the identification of high vulnerable data processes and systems (via high-level assessments).
  • Determines strategy and collaborates with team members and functional SME's to drive the execution of data mappings.
  • Systematically describes the data in processes, systems, and equipment throughout the data lifecycle (creation, processing, review, reporting, retention, and destruction of data).
  • Serves as the subject matter expert for performing data mappings.
  • Identifies risks to data integrity associated with the business process flow and the data flow throughout the data lifecycle.
  • Analyzes and performs a quantitate evaluation of the identified risks.
  • Determines controls to mitigate, reduce, or eliminate data integrity risks, aligning with functional SME is to assign ownership of the identified actions.
  • Ensures the completed data mapping report is archived. Develop and maintain a tool for sharing of completed data maps across the network.
  • Shares lessons learnt / best practices identified / opportunities for alignment / productivity improvements to the relevant stakeholders.
  • Identifies and maintains a network of functional Subject Matter Experts (SME) (e.g. QC, QA Ops and Compliance, Manufacturing, MS&T, Engineering, Regulatory, Clinical Operations, Global Patent Safety, Pharmacovigilance, Pre-clinical functions).
  • Works closely with the Site Data Integrity Lead to execute the data mappings.
  • Continuously improves data integrity knowledge base and understanding of functional SME's by highlighting how process improvements or systems upgrades / reconfiguration can strengthen the controls in place to ensure the integrity of data.
  • Conducts data mapping methodology awareness sessions with functional SME's.
  • Plans onsite or virtual meetings and workshops with the functional SME's.
  • Coordinates with functional SME's to perform pre-work, including a review of process/procedures related to the process/system under evaluation and review of any DI related deviations and/or inspection findings for the system/process.
  • Supports audits related to Data Integrity for both internal and external parties.
  • Supports preparation for regulatory/health authority inspections and/or response development for DI related topics.
  • Drives, monitors and assures delivery of the Data Mapping Execution Plan, and periodically report status/progress to site DI leads and/or site leadership, the organization DI Lead and/or the organization Quality Leadership Team and Novartis Group Quality.
  • Promotes DI reporting aligned with Speak-Up office for DI relevant cases to assure they are managed appropriately across the interface between the Speak-Up office and Quality Investigation and corrective/preventative action processes.
  • Escalates any critical gaps identified during data mapping.
  • Evaluates if an existing data map may require update associated with changes to how data are recorded, processed, reviewed, reported, retained or destroyed.
  • Leads and mentors assigned employees.
  • Other Related duties as assigned.

Qualifications
  • B.S. degree in a scientific discipline.
  • 7 years' experience supporting GxP activities.
  • In-depth knowledge of FDA regulations and GMP systems in a highly regulated or pharmaceutical / biotech facility.
  • Cross-functional experience in one or more of the following GxP regulated functions (e.g Quality Assurance or Quality Control, Clinical Operations, PV, Pre-Clinical Operations, Manufacturing / Engineering / Automation operations, Quality Management Departments or equivalent external consultant positions.
  • Good knowledge of the application of ALCOA+ principles and 21CFR Part 11 requirements in paper, hybrid and electronic systems.
  • Strong operational background preferred.
  • Strong focus on details and data with significant experience in quality risk management principles.
  • Experience with handling raw data during the different stages of the data lifecycle preferred.
  • Direct industry Data Integrity related experience an advantage.
  • Experience working with diverse stakeholders, with ability to drive and manage change.
  • Experience with and understanding of data flows in electronic systems.
  • Strong experience in supporting risk analysis, project management, communication and presentation skills.
  • Ability to synthesize detailed information and provide clear communication and messaging across functions.
  • 25% travel.


Novartis Gene Therapies Compensation and Benefit Summary:

The salary range for this role is from $94,000/year to $150,000/year. The base salary ultimately offered may vary based on the successful candidate's qualifications. The level of this role will also be determined based on the successful candidate's qualifications. 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