Senior Manager, Information Systems Quality and Data Integrity
General position summary: Manages resources to provide Quality oversight of Data Integrity and Technology for GxP lifecycle activities and practices for Vertex Cell and Gene Therapy (VCGT). Additionally, acts as a Subject Matter Expert for electronic Data Integrity topics.
The responsibilities of this position may include, but are not limited to, the following:
- Facilitate holistic data integrity reviews by partnering with QA and stakeholders to conduct end to end business processes assessments.
- Prioritize gaps and risks and provide oversight to needed remediation activities.
- Serving as a Strategic Quality Lead (providing quality oversight, project management, leadership, and participation) for IT function managed computerized system life cycle (SLC) activities for VCGT GxP systems.
- Collaborating with GxP QA groups to provide support for inspections and mock audits.
- Collaborating with GxP QA groups to host agency inspections.
- Managing and Facilitating Data Mapping initiatives for programs level processes.
- Owning and managing electronic data integrity training.
- Providing Business Analyst skills and resources to projects across QA to facilitate requirements gathering, development of process/ data flow maps, and data integrity assessments.
- Authoring, reviewing, and approving work process documents (SOPs and Work Instructions).
- Generating and maintaining metrics for Quality Leadership Teams.
- Identifying, escalating, monitoring/ reporting, and resolving quality risks and gaps to Quality Leadership Teams.
- Identifying and implementing continuous improvement opportunities.
- Leading oversight of electronic data integrity compliance guidance for VCGT GxP systems.
- Assessing emerging needs in the industry to identify technology/ skills gaps within the team.
- Coordinating with project stakeholders, GxP QA areas, and business representatives to ensure QISM is involved, informed, and accountable for VCGT activities and initiatives within the QISM scope.
- Participating in defining and executing VCGT operational and aspirational strategies.
This position is accountable to ensure the successful execution of the following:
- Review and approval of SLC and QMS processes related deliverables.
- Participating in Program Integrated Risk Governance Teams as the Data Integrity Lead.
- Conducting (including the scheduling, preparation, conduct, reporting, and follow-up/ closure of) electronic data integrity audits, as needed to support the Data Integrity of VCGT systems, processes, and data.
- Participating in VCGT GxP Quality Leadership Teams.
- Managing people by workforce planning, employee development, talent acquisition, performance oversight, and communication.
- Participate in the oversight and Governance of Quality-Owned Computerized Systems and Processes.
- Participate in the definition and implementation of the Quality Technology Roadmap.
- Lead by Example
- Learn, Teach and Develop.
- Foster Exceptional Collaboration
- Drive Break Through Results
- Promote Enterprise Thinking
Education and Experience qualifications:
- A Bachelor’s degree in a Computer Science, Information Management, or STEM related area of study required.
- 6 or more years of experience in Computerized Systems Quality Assurance and Data Integrity in the Pharma or Biotech industry is required.
- Deep and broad knowledge of applicable GxP (and Electronic Records/ Electronic Signatures) industry regulations.
- Ability to travel up to 10% of the time (domestic and international)
- Certified Quality Auditor Certification (ASQ) or equivalent
- Certified Data Integrity Manager or equivalent
- Certified Manager of Quality and Operational Excellence
We’re enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid- or On-Site-Eligible role, you can choose to work:
1. Hybrid and work remotely up to two days per week on regularly scheduled days; or select
2. On-Site work 5 days per week with ad hoc flexibility.
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.
Please note that Vertex requires COVID-19 vaccination for all employees working in the U.S. as a condition of employment at Vertex, subject to medical, religious or other accommodations or exemptions required by law. We believe this requirement is vital to keeping everyone at Vertex and in our communities safe. This requirement applies to both existing and new employees who may at any time work on-site at a Vertex facility or visit another location on behalf of Vertex (e.g., conferences, customer visits, etc.), including all remote employees. 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 [Register to View]