GCP Quality Associate Director

Job 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 RDQ. This role will support GCP related events and escalation of these events to Senior Management and other key stakeholders. This individual will work closely with Quality Leads, Study team members, and other pillars in the Quality organization and will demonstrate Vertex Core Values.


RESPONSIBILITIES:

• Assist in the continuous improvement of the Issue Management process- handling of QEs, trending, and updating processes.
  
  

• 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, Global Clinical Quality and other Subject Matter Experts, as needed.
  
  

• Escalate critical and major findings to Quality management and monitor key performance indicators.
  
  

• Utilize quality tools and techniques to support or perform and document full root cause and investigations, to evaluate and resolve quality issues, and to enhance continuous improvement.
  
  

• Assist in tracking of event completion in expected timeframes and monitor quality of investigation writing.
  
  

• Create investigation and deviation records in the electronic Quality Management System..
  
  

• Communicates proactively with internal and external partners and management.
  
  

• Serve as a Subject Matter 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 and present results, where needed.
  
  

• 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
  
  

• Assist in Quality Risk Assessment and Management
  
  

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 Health Authority inspections and audits
  
  

PREFERRED EDUCATION AND EXPERIENCE:

• Bachelor's Degree and 10 years of relevant work experience or a combination of training and experience
  
  

Pay Range:
$160,600 - $240,800

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:
Hybrid-Eligible Or On-Site Eligible

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.


#LI-Hybrid

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 View email address on click.appcast.io