Vertex Pharmaceuticals

Analytical Quality Assurance, Associate Director

Boston, MA · Director

Sponsorship not specified$157k-$235kDetected 4 days ago

Data AnalysisData VisualizationRecruitingGMPFDA RegulatoryCommunicationProblem SolvingCritical ThinkingGxP

About the role

Job Description General Summary: The Associate Director (AD) Quality Assurance (QA for QC) is an advanced technical resource in the principles and application of quality assurance and compliance.
This role is responsible for the quality oversight of Quality Control and analytical development activities of Cell & Gene programs.
The role will have QA oversight of technical analytical method validations and analytical transfer activities internally /CDMOs through the program life cycle management.

Serve as a Quality Assurance Subject Matter Expert for in QC domain and drive culture of quality to assure compliance with FDA, EMA, and internal SOPs.
Lead QA review and approval of analytical development, qualification and validation as well as analytical technical transfer activities
Perform/lead QA review and approval of QC associated documentation including deviation investigations, OOS, OOT and change control.
Responsible for using platforms such as MES, LIMS, eQMS, data visualization tools, and advanced analytics to perform Quality oversight.
Support/lead QA risk management activities, including mitigation plans and associated execution.
Support development of Vertex quality systems and processes, draft/revise SOPs, policies and work instructions.
Identify, facilitate, and/or lead continuous improvement efforts
Ensure development of quality metrics at the contract organizations that support excellence in quality systems
Activities in scope of this role include release analytical testing, stability testing, and QA support for deviations and out of specification investigations.

In-depth global regulatory agency and technical knowledge and experience across GXP QA and QC activities in cell therapies
Broad understanding of regulatory environment including quality systems, compliance and GMP regulations.
Experience with platforms such as MES, LIMS, eQMS, data visualization tools, and advanced analytics is preferred.
Prior experience working /running internal analytical lab and working with external Test labs.
Experience in analytical method development
Critical Thinking and Problem Solving skills
Education and Experience:
Master's degree in a scientific or allied health field (or equivalent degree)
Ph.D. preferred
8+ years of experience, or the equivalent combination of education and experience in a regulated pharmaceutical environment.
Execute QA operational oversight for internal QC laboratories and external contract testing laboratories.
Drafts and enforces Quality Agreements between Contract Test Labs and Vertex.

$156,600 - $234,800
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.

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 ApplicationAssistance@vrtx.com

This listing is sourced directly from Vertex Pharmaceuticals's careers page and normalized into a canonical job model.