Senior Manager, GCP Compliance and Operational Area Quality

Job Description

General Summary:

The Senior Manager, GCP Compliance is responsible for the quality assurance and compliance activities in support Operational Quality Issues Management. This role will act as a primary Quality Event manager for GCP related events. This individual will work closely with Quality Leads and Study team members and will demonstrate Vertex Core Values.

Key Duties and Responsibilities:

• Manage (internal and external) GCP Quality Events including, but not limited to investigations, CAPAs, Root Cause Analysis, Effectiveness Checks).
• Perform initial triage of event criticality working with operational Quality or Program leads and other Subject Matter Experts, as needed.
• Escalate critical and major finding to Quality management and monitor key performance indicators.
• Assemble Event Action Committees (EACs) as required as well as convene Quality Review Board (QRB) meetings and provide support (e.g., agendas, minutes) as necessary
• Utilize quality tools and techniques to support or perform and document full root cause investigations, to evaluate and resolve quality issues, and to enhance continuous improvement
• Aid with development of corrective and preventive
• May supervise day to day execution for Investigator Coordinator (IC) activities and back up IC for triaging events in expected timeframes.
• Create investigation and deviation records in VEEQMS
• Communicates proactively with internal and external partners and management.
• Collaborate with Quality Lead and Program Lead functions as well as the business contacts.
• May update risk tables to support Integrated Risk Governance Team meetings
• Generates Metrics / KPIs, Dashboards and Reports, as requested
• Participate in inspection readiness and support activities
• Participate in process improvement initiatives related to Issue Management
• Maintains files such that documents are readily available and easily retrievable.

• May assists with onboarding and ongoing training team members
• Assist in additional Quality Assurance initiatives as applicable

Required Knowledge and Skills:

• Experience successfully leading event investigations, Root Cause Analysis and CAPA
• Knowledge of current industry trends and ability to use the latest technologies
• Highly organized with strong planning capabilities
• Compliance and quality management experience (across multiple GxP areas) preferred
• 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:

• Bachelors Degree in a scientific or allied health field
• Typically requires 6 years experience or the equivalent combination of education and experience

Pay Range:

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Flex Designation:

Flex Eligibility Status:

In this Remote-Eligible role, you can choose to be designated as:
1. Remote : work remotely five days per week and come into the office on occasion - you're always welcome on-site; or select
2. Hybrid : work remotely up to two days per week; or select
3. 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.

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