Senior Manager, CGP Compliance & Issue Management (Hybrid)

Job Description

GENERAL POSITION SUMMARY:

The Senior Manager, RDQ Compliance is responsible for leading quality assurance and compliance activities in support of Compliance and Issues Management. This role requires expertise in overseeing investigations, root cause analysis, CAPA development, and effectiveness checks, as well as the ability to educate and guide stakeholders in performing effective root cause investigations. The ideal candidate will have experience in linking issues and risks, conducting data analysis, performing spot checks, and leveraging data trending to identify patterns and drive continuous improvement. This individual will work closely with Quality Leads, Study Team members, and other stakeholders while exemplifying Vertex Core Values.

RESPONSIBILITIES:

• Quality Oversight and Monitoring:
  • Conduct regular spot checks to ensure adherence to GCP (Good Clinical Practice) standards and compliance with established processes.
  • Perform data trending and analysis to identify recurring issues, emerging risks, and opportunities for process improvement.
  • Monitor and evaluate key performance indicators (KPIs) to assess the effectiveness of quality and compliance activities.
• Issue Management and Investigations:
  • Oversee internal and external GCP Quality Events, including but not limited to investigations, CAPAs, root cause analysis, and effectiveness checks.
  • Perform initial triage of event criticality in collaboration with Quality or Program Leads, Event Owners and other Subject Matter Experts (SMEs).
  • Escalate critical and major findings to Quality management and ensure timely resolution.
  • Oversee and provide guidance on root cause investigations, ensuring they are thorough, well-documented, and address the underlying issues.
  • Educate and mentor stakeholders on best practices for conducting effective root cause analysis to improve investigation quality and outcomes.
• Corrective and Preventive Actions (CAPAs):
  • Oversee the development, implementation, and monitoring of corrective and preventive actions to address identified issues.
  • Ensure CAPAs are aligned with root cause findings and monitor their effectiveness through regular reviews and effectiveness checks.
  • Assist in driving alignment on CAPAs and process updates.
• Data Management and Reporting:
  • Generate metrics, KPIs, dashboards, and reports to provide insights into quality trends and compliance performance.
• Collaboration and Communication:
  • Collaborate with Quality Leads, Program Leads, and business contacts to ensure alignment on quality and compliance objectives.
  • Communicate proactively with internal and external partners, as well as management, to provide updates and address concerns.
• Inspection Readiness and Training:
  • Participate in inspection readiness and support activities, ensuring all documentation is accurate, complete, and readily accessible.
  • Assist with onboarding and ongoing training of team members to ensure consistent understanding and application of quality standards.
  • Provide training and education to stakeholders on effective root cause analysis techniques and tools to enhance investigation outcomes.
• Process Improvement:
  • Participate in and lead process improvement initiatives related to Issue Management, leveraging insights from spot checks and data trending to drive enhancements.
  • Assist in additional Quality Assurance initiatives as applicable

REQUIRED KNOWLEDGE, SKILLS, AND COMPETENCIES

• Experience successfully leading and overseeing event investigations, Root Cause Analysis and CAPA
• Strong analytical skills to evaluate complex data sets, identify trends, and derive actionable insights to support quality assurance and compliance activities
• Knowledge of current industry trends and ability to use the latest technologies
• Highly organized with strong planning capabilities
• Compliance and quality management experience
• Strong communication, problem solving and critical thinking skills
• Ability to work under minimal supervision
• Experience with quality management applications such as Veeva preferred

EDUCATION AND EXPERIENCE:

• Bachelor's Degree and 6 years of relevant work experience or a combination of training and experience

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Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

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Company Information

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 ApplicationAssistance@vrtx.com