Senior Manager, GCP Quality Lead (Remote)

Job Description

General Summary :

The Senior GCP Operational Quality Manager 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.

Key Duties and Responsibilities :

• Serves as the Clinical Study 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.
• Provide guidance, interpretation and information on regulations, standards, and quality systems to GCP functional areas responsible for clinical trial execution.
• Provide subject matter expertise and participate in the development and review of study level documents (e.g. Protocols, Informed Consent documents) and procedural documents related to the QMS (e.

g., CAPA and Quality Issue Management, regulatory inspections, quality risk management).

• 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 level 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 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 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 on process improvement initiatives.
• Develop and maintain QA to QA relationships with GCP Vendors to conform to quality agreements, and participates in applicable Vendor Joint Operating Committees, as needed.

Knowledge and 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 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.
• May require up to 10% travel.
• Experience in Cell & Gene Therapy studies.

Education and Experience :

• Bachelor's degree in scientific or allied health discipline.
• Typically requires 6 years of experience or the equivalent combination of education and experience.

Pay Range : $132,880 - $199,320

$132,880 - $199,320

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 : Remote-Eligible

Remote-Eligible

Flex Eligibility Status :

In this Remote-Eligible role, you can choose to be designated as :

The following information provides an overview of the skills, qualities, and qualifications needed for this role.

1. Remote : work remotely five days per week and come into the office on occasion - you're always welcome on-site; or select

2. Hybrid : work remotely up to two days per week; or select

3. 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.

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 [email protected]

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Remote working / work at home options are available for this role.