Vertex Pharmaceuticals Incorporated
Associate Director, Quality Operations, Commercial Manufacturing - Cell & Gene T
Vertex Pharmaceuticals Incorporated, Boston, Massachusetts, us, 02298
Overview
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, identifying and communicating compliance risks, 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 Vertex's Leiden Center Building (LC1), 316-318 Northern Ave, Boston, MA-02210. 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 well-being 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). Liaises 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 teams in development of risk mitigation strategies. Develops risk-based 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 assists 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. Develops and maintains QA-to-QA relationships with GCP Vendors to conform to quality agreements, and participates in applicable Vendor Joint Operating Committees, as needed. Required Education
Bachelor's degree in a Biotech/Life sciences field. Preferred master's 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
In-depth 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. In-depth 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 (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
Travel up to 5% may be required. Pay Range
$154,100 - $231,200 Job Description (Consolidated)
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. 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. Vertex is an equal opportunity employer. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants. 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. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. Flex Designation Hybrid-Eligible Or On-Site Eligible
#J-18808-Ljbffr
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, identifying and communicating compliance risks, 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 Vertex's Leiden Center Building (LC1), 316-318 Northern Ave, Boston, MA-02210. 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 well-being 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). Liaises 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 teams in development of risk mitigation strategies. Develops risk-based 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 assists 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. Develops and maintains QA-to-QA relationships with GCP Vendors to conform to quality agreements, and participates in applicable Vendor Joint Operating Committees, as needed. Required Education
Bachelor's degree in a Biotech/Life sciences field. Preferred master's 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
In-depth 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. In-depth 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 (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
Travel up to 5% may be required. Pay Range
$154,100 - $231,200 Job Description (Consolidated)
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. 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. Vertex is an equal opportunity employer. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants. 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. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. Flex Designation Hybrid-Eligible Or On-Site Eligible
#J-18808-Ljbffr