Location: Boston, MA
The Director, Quality - Data Integrity and Technology, as part of the Vertex Quality Assurance Organization, is responsible for envisioning Vertex Data Integrity policy and maturing Quality Management System (QMS) standards and policies related to Information Systems Management. This position will be responsible for leading pan-GxP leaders to develop policies to ensure holistic data integrity across all aspects of product development by working closely with the Operational leaders and Operational Quality leaders.
The incumbent will have dual responsibilities of advancing the data integrity awareness within Vertex while also integrating the defined standards across all aspects of product development. The key responsibility of this role would develop a holistic framework of standards that will ensure end-to-end assessments of the processes including assessment of data flows and back-bone technologies supporting the process. The role will further entail prioritization of gaps and risks assessment by leveraging pan-GxP knowledge and in collaboration with Quality operations and Business leaders. As part of this the individual will develop a GxP aligned risk framework that will ensure consistent, phase appropriate and fit of purpose gaps and risks assessments.
The individual will ensure above programs and underlying activities are conducted using risk- based methodologies that assure adherence to applicable regulations, industry standards, and to Vertex policies, procedures and quality standards as set forth in the Quality Management System. As part of this role, the incumbent will be required to forecast and monitor budget and resources in addition to developing a robust team to support Vertex Data Integrity related activities.
The Director will provide strategic, risk- based and phase-based direction to the above programs and in addition will oversee risk mitigation action plans including corrective and preventive actions. Given that DI standards are companywide and impact all GxP areas, including the vendors and CxOs, the individual will ensure comprehensive cross functional collaboration and broad-based risk and impact assessments.
Vertex is an exciting, fast paced dynamic environment with a strong company culture focused on patients with unmet medical needs. The ideal candidate is someone with experience in business analysis and deep understanding of a broad set of technologies including cloud-based systems in multiple GxP areas.
Position may require up to 10% national/international travel.
- Data Integrity (DI):
- As the head of Data Integrity Quality System, the incumbent will have the responsibility of advancing Vertex Quality Management System (QMS) by developing strategic and business aligned holistic data integrity controls and governance.
- Responsible for overall performance of Data Integrity program in assuring quality risk management/mitigation and the adequacy and adherence to controls for quality and compliance with regulatory requirements (and guidance, etc.) and internal standards
- Responsible for integrating DI policy framework within the existing Quality Management Systems policies and processes. This includes information systems life cycle management, vendor audit and vendor management processes and several other business processes that outline the use of data.
- Serves as the Lead of Data Integrity function with responsibility of the overall strategic direction, performance and effectiveness of the Data Integrity program.
- Sets up data integrity program maturity trajectory based on Vertex and Quality goals, pan-GxP management reviews and risk frameworks.
- The Director will drive prioritization of pan GxP DI assessment and remediation in collaboration with senior quality and business leaders and providing oversight to execution of Quality standards.
- Partners with business stakeholders and leverage the knowledge of pan GxP functional areas to drive GxP appropriate risk assignments and development of mitigation plans.
- Leads cross functional teams of senior leaders to develop innovative, business centric solutions pertaining to data integrity gaps.
- Leads Data Integrity related due diligence activities to facilitate Vertex business development activities.
- Build out and develop DI experts within the organization to ensure rapid advancement and maturation of
- Guides quality analytics team to develop Data integrity related Vertex QMS aligned and leads management reviews with EQLT and QLTs.
- Responsible for aligning Information Systems risk based criteria with Vertex GxP operations to ensure consistency in mitigation efforts.
- Responsible for developing data integrity risk framework to ensure consistent assessment across GxP processes.
- Lead and facilitate end to end process reviews to clearly identify data sources and align those with data life cycle stages.
- Identify key data integrity metrics and word in collaboration with other Quality functions and business stakeholders to ensure routine management review of DI metrics.
- Partner with stakeholders to advance data standardization, process simplification data quality enhancement and automation where needed.
- Partner with QA, GIS and other stakeholders to ensure consistent review of the processes from DI standpoint. The incumbent will be required to baseline current DI capabilities and advance those to drive deep and broad understanding of underlying risks pertaining to the process, data ownership, backbone technologies and personnel.
- Partner with Audit and Inspection teams to facilitate adoption of defined DI principles within the vendor audit and inspection readiness programs.
- Partner with QA leadership and business leadership including GIS leadership, for coordination and alignment in ensuring overall quality of data and adequacy is consistently maintained
- Collaborate with other QISM leaders to ensure holistic assessment of compliance of information systems including assessment of interconnected systems and other dependencies to identify gaps and risks across end-to-end data flows
- Collaborate with stakeholders to develop and maintain DI compliance metrics and report to Quality leadership Teams (QLTs) as needed.
- Responsible leading teams within Data Integrity and Technology to ensure overall performance of Data Integrity program.
- Responsible for assessing team's capabilities and setting up development plans to ensure comprehensive talent pool aligned to the data integrity program.
- Estimate and forecast resources for both full time and contractor requirements based on the program maturity trajectory.
- Estimates budgetary requirements and monitor spending.
- Actively identifies talent and
- Key contributor to the data integrity governance and management forums across various GxP areas.
- Participate in collaborative review of impacted SOP/WI
- Analyze risk and propose remedial, corrective and /or preventive actions
- May participate on process improvement initiatives
- Provide cross-functional support across Vertex Quality Assurance team
- Support due-diligence and business development activities, as requested
- Minimum qualifications:
- M.S. (or equivalent degree) and 7+ years of relevant work experience, or
- B.S. in a scientific or allied health field and 10+ years of relevant Computer System/Data Integrity audit program development/maintenance and execution using risk frameworks in the regulatory compliance environment, or relevant comparable background.
- In-depth knowledge in the following areas:
- Broad and deep knowledge and demonstrated experience with global regulatory requirements and standards/best practices for computer systems within GxP-regulated environments
- Demonstrated depth and breadth of global health regulatory agency knowledge and GxP experience with current knowledge of industry trends and best practices for computer systems quality, data integrity, compliance and systems controls effectiveness
- Broad and deep quality management, computer systems management, process management, project management and continuous improvement knowledge and experience
- Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence
- Strong problem solving and critical thinking skills, accompanied by Analytical thinking/Data Analysis skills required to make sound decisions
- Risk management principles and process, change management
- Communicates professionally, clearly, concisely and consistently both verbally and in writing to internal and external customers.
- Must be able to organize and prioritize work effectively to meet timelines with quality deliverables.
- Must be able to work independently and in a collaborative team setting.
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at (see application details).