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Form of workJob Description
GENERAL POSITION SUMMARY:
The Associate Director, GCP Compliance is responsible for the quality assurance and compliance activities in support Quality Issues Management and other activities within RDQA. This role will act as a support for GCP related events and escalation of these events. This individual will work closely with Quality Leads, Study team members, and other pillars in the Quality organization and will demonstrate Vertex Core Values.
**This is a hybrid position**
RESPONSIBILITIES:
REQUIRED KNOWLEDGE, SKILLS, AND COMPETENCIES
REQUIRED EDUCATION AND EXPERIENCE:
Hybrid-Eligible Roles
In this Hybrid-Eligible role, you can choose to be designated as:
Hybrid: work remotely up to two days per week; or selectOn-Site: work five days per week on-site with ad hoc flexibility.
#LI-Hybrid #LI-AR1
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.
GENERAL POSITION SUMMARY:
The Associate Director, GCP Compliance is responsible for the quality assurance and compliance activities in support Quality Issues Management and other activities within RDQA. This role will act as a support for GCP related events and escalation of these events. This individual will work closely with Quality Leads, Study team members, and other pillars in the Quality organization and will demonstrate Vertex Core Values.
**This is a hybrid position**
RESPONSIBILITIES:
- Assist in the continuous improvement of the Issue Management process- handling of QEs, trending and updating processes.
- May manage or assist in (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 (5 why) to support or perform and document full root cause investigations, to evaluate and resolve quality issues, and to enhance continuous improvement.
- May assist in tracking of event completion in expected timeframes and monitor quality of investigation writing.
- May create investigation and deviation records in VEEQMS.
- Communicates proactively with internal and external partners and management.
- Expert in the risk-based approach to quality events, and using data to inform trends and next steps in continuous improvement process.
- Generates Metrics / KPIs, Dashboards and Reports, as requested.
- Participate in inspection readiness and support activities
- May assist with onboarding and ongoing training team members, and may manage direct reports, as needed.
- Assist in additional Quality Assurance initiatives as applicable, including inspection, audit activities
REQUIRED KNOWLEDGE, SKILLS, AND COMPETENCIES
- 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 GCP quality management experience
- Strong communication, problem solving and critical thinking skills
- Knowledge of overall issue management processes, risk based approaches, and best practices
- Experience in quality analytics and using data to make decisions and identify trends
- Experience in inspections and audits
REQUIRED EDUCATION AND EXPERIENCE:
- Bachelor's Degree and 10 years of relevant work experience or a combination of training and experience
Hybrid-Eligible Roles
In this Hybrid-Eligible role, you can choose to be designated as:
Hybrid: work remotely up to two days per week; or selectOn-Site: work five days per week on-site with ad hoc flexibility.
#LI-Hybrid #LI-AR1
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.
