Description

Job Description

The Clinical Quality & Development Operations (CQDO) Associate Director is a key contributor in Global Clinical Operations (GCO's) audit and inspection management program, focusing on GCP health authority inspection planning, logistics, pre and post inspection support, ensuring all activities are conducted in compliance with health authority regulations (e.g. FDA, EMA, etc.). In addition, the Associate Director will also contribute to regulatory intelligence activities, partner with local R&D functions and study teams to create a quality culture within Vertex and help reach a sustained state of inspection readiness.

Key Responsibilities:

• Lead inspection readiness and preparedness activities for GCO, including training/preparation and back room activities, and support back room during GCP inspections

• Build and maintain strong and productive relationships with key stakeholders within GCO and QA to support the successful and compliant execution of regulatory inspection activities.

• Maintain in-depth knowledge of governmental regulations affecting GCP in the drug development process.

• Lead, plan, and coordinate GCO activities to support GCP regulatory authority inspections (routine, directed or submission driven)

• Serve as the primary CQM contact to provide support to clinical investigator sites undergoing regulatory authority inspections in EU.

• Serve as technical resource for audits/inspections as needed

• Represent and support Global Clinical Operations in internal process audits as needed

• Lead Global Clinical Operations audit/inspection planning, management and response generation

• Lead Global Clinical Operations in the Development of CAPA plans and investigations in response to audits and inspections for Global Clinical Operations.

• Ensure inspection findings are remediated and processes are implemented within GCO.

• Develop and maintain inspection management plans, trainings, and strategies for the GCO inspection management program.

• Review and provide input into study team storyboards, and general inspection readiness activities.

• Assess and review the regulatory landscape, contribute to the interpretation, analysis, facilitate impact assessments as applicable to GCO departments and disseminate accurate regulatory intelligence.

• Lead, manage and coordinate pre-inspection preparation activities such as inspection management trainings, mock inspection interviews, mock inspections, and risk assessments in preparation for regulatory authority inspections.

• Lead, manage and provide expert guidance and direction in development of responses to observations assigned to GCO resulting from inspections.

• Ensure any critical and major inspection findings have appropriate Corrective and Preventative Actions (CAPA) and are tracked to completion and verification of effectiveness.

• Lead and manage post-inspection lesson's learned sessions, identifying trends and best practices to ensure identified process improvement opportunities are implemented.

• Collaborate with industry through benchmarking of regulatory activities that may influence regulatory inspection activities and strategies.

Key Requirements:

• Relevant Degree
• Advanced understanding/knowledge of GCP, ICH guidelines and Health Authority regulations

• Advanced/In-depth understanding of relevant Clinical Research and industry trends

• Expert knowledge in system/technical tools and processes.

• Advanced data visualization and analytics.

• Lead cross-functional projects of high complexity with cross-functional team members within and outside department.

• Prioritizes work accordingly to meet departmental needs, work toward and meet deadlines with minimal supervision.

• May lead a department or sub-department initiative.

• Applies understanding of the business and how own area integrates with others to achieve departmental objectives.

• Excellent critical thinking, decision making and problem-solving skills.

• Responsible for aligning with workforce planning for resourcing needs.

• Experience with site/process audits and regulatory inspections

• Demonstrated attention to detail and accuracy in a fast-paced environment.

• Drives breakthrough results

• Promotes enterprise thinking

• Strong interpersonal skills with an ability to effectively work and problem solve within a multidisciplinary team.

• Excellent verbal and written communication and presentation skills

• Displays highly-evolved writing and verbal presentation skills, with the ability to convey complex/technical findings to varied audiences and persuade other to adopt a different point of view

• Experience managing external vendors.

• Significant experience with guiding and coaching employees

• Adapts plans and priorities to meet short term objectives.

Flex Designation:
Remote-Eligible

Flex Eligibility Status:

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

#LI-Remote

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