Associate Director, GMP Operational Quality, Cell & Gene (Wed - Sat, Second Shift)

Job Description

The Associate Quality Director conducts quality assurance oversight and management activities of clinical trial operations to ensure Vertex trials are conducted in accordance with Good Clinical Practice (GCP) guidelines applicable regulations protocols and Vertex policies and procedures. These activities include the development and execution of study level audit plans accurately identifying and communicating compliance risks and overseeing action plans to mitigate risks monitoring quality issues and compliance metrics investigation and CAPA management and proactive inspection readiness activities.

This role is located at Vertexs Leiden Center Building (LC1) 316318 Northern Ave Boston MA02210. This is a second shift role from Wednesday to Saturday 12:30 to 11pm.

Key Duties & Responsibilities

• Leads a team in the Quality Operations organization responsible for internal commercial operations in support of GMP manufacturing and testing activities including disposition of intermediates working cell banks and clinical and commercial drug products internally at Vertex manufacturing facilities.
• Serves as the Quality Lead for assigned clinical programs providing GCP compliance interpretation consultation and other support services necessary to maintain and/or improve the quality of Vertex research to ensure the protection of subjects safety rights and wellbeing as well as the integrity and credibility of data generated.
• Maintains a contemporary knowledge of current industry trends standards and methodologies as it relates to Good Clinical Practice (GCP).
• Liaise with Vertex clinical functions and external parties including CROs Vendors and investigator sites to promote high levels of quality and consistency across and within programs.
• Provides QA review of protocols and participates on Operational Review Boards to identify operational risks and collaborates with study team in development of risk mitigation strategies.
• Develops riskbased audit plans for assigned programs ensures audits are conducted in accordance with the plan reviews audit reports evaluates responses and CAPA plans in accordance with company standards and policies.
• Manages and/or leads domestic and international audits for Clinical Investigators to ensure compliance to ICH GCP applicable regulations and company standards.
• For assigned programs/ studies leads quality issue investigations root cause analysis and CAPA development and assist study teams in implementing corrective and preventive actions in support of sustainable compliance.
• Contributes to the development and implementation of continuous quality improvement initiatives.
• Engages with study teams and functions for proactive inspection readiness across assigned programs.
• Provides inspection support as necessary for Regulatory Agency inspections held at Vertex facilities or Clinical Investigator sites.
• May serve as GCP Quality Management System representative
• Participates in collaborative review of impacted SOP/WI
• Reviews and analyzes key Performance Indicator data and trends
• Analyzes risk and proposes remedial corrective and /or preventive actions
• May participate in process improvement initiatives
• Develop and maintain QA to QA relationships with GCP Vendors to conform to quality agreements and participate in applicable Vendor Joint Operating Committees as needed.

Required Education Level

• Bachelors degree in a Biotech/ Lifesciences field.
• Preferred masters degree or relevant comparable background.

Required Experience

7 years of relevant industry experience such as manufacturing quality assurance and/or quality control in biotechnology/regulated pharmaceutical environment.

Required Knowledge/Skills

• Indepth knowledge of ICH GCP R2 and applicable global regulations and guidance for clinical development (e.g. FDA regulations EU Regulations and Directives MHRA Statutory Instruments etc.)
• Strong experience with all phases of clinical trial development involving drugs biologics devices and drug/ device combinations.
• Indepth knowledge of Event Management processes and requirements including investigation root cause analysis CAPA plan development and Effectiveness Checks.
• Ability to understand and translate customer needs bringing a new perspective to existing quality management solutions
• Communicates professionally clearly concisely and consistently both verbally and in writing to internal and external customers.
• Ability to work independently with minimal guidance organizing and prioritizing work effectively for timeliness accuracy and quality
• Proficient in managing complex projects achieving goals and deadlines.
• Proficient in using Microsoft Office applications is an asset (MS Word MS Excel MS PowerPoint Visio
• Strong experience with key performance indicators metrics analysis and monitoring/trending of quality and compliance metrics

Other Requirements
Indicate required certifications licenses or specialized trainings.

• Up to 5% Travel may be required

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this HybridEligible role you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. OnSite: work five days per week onsite with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertexs 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 nondiscrimination for all employees and qualified applicants without regard to a persons 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 EVerify 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