Director Clinical Quality & Development Operations Inspection Excellence

Job Description

General Summary:

The Director, Clinical Quality & Development Operations (CQDO) Inspection Excellence 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 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 Duties and Responsibilities:

• Lead inspection readiness and inspection preparation activities for GCO, including SME training/preparation and back-room activities, and manage back-room during GCP inspections.
• Analyze the risks, propose the strategy for readiness and manage the implementation of readiness program
• Provide lessons learned after each GCP inspection
• Participate in internal process audits as needed
• Contribute to GCO audit and inspection planning, management and response generation.
• In collaboration with Audits and Inspection Management (AIM), develop and approved annual internal audit schedule
• Oversee GCO Quality Event management and assist in the development of CAPA plans and investigations in response to audits and inspections.
• Ensure inspection findings are remediated, and processes are implemented within GCO.
• Oversee management and communication of lessons learned from GCO studies to ensure all functions operate consistently, and develop method for continuous process improvement
• Collaborate cross functionally with partners including but not limited to Global Clinical Quality (GCQ), Regulatory Affairs, and Global Patient Safety (GPS).
• Advanced leadership and execution of business strategy
• Comprehensive understanding of inspection concepts and principles in multiple disciplines and a broad knowledge of others. Oversees multiple projects within domain in support of CQDO deliverables and is a SME for Inspection Excellence domain.
• Demonstrated leadership in inspection readiness planning and execution for clinical trial submissions across multiple regulatory agencies, including but not limited to FDA, EMA, MHRA, PMDA, and CDE.
• Strong knowledge and demonstrated experience applying riskbased quality principles (e.g., Quality by Design [QbD]) within a pharmaceutical or regulated environment.
• Current and comprehensive knowledge of industry trends, regulatory expectations, and best practices related to progressive quality risk management in a regulated environment.
• Drive the development of innovative solutions that address evolving business needs in line with standards
• Identifies and resolves technical and operational problems, understands broader impact on the department
• Provides strategic input to solve complex problems while exercising judgment using multiple sources of information.
• Maintain understanding of the stakeholder landscape and identify areas for alignment across stakeholders.
• Communicate clear and convincing opinions, ideas, and positions, tailored to the audience, in a poised, confident, and convincing manner.
• Develop solutions that fully address business needs and align standards.
• Guides others either internally or externally to adopt a different point of view.
• Express views with conviction that gains support from stakeholders, even when they may have a different opinion or when the subject matter is unfamiliar.
• Provides mentorship, leadership and guidance to junior level staff or Functional Service Provider (FSP) personnel.
• As a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff

Knowledge and Skills:

• Advanced understanding of GCP, CFR and ICH guidelines and Health Authority regulations
• Advanced ability to leverage knowledge of organizational goals and interdependencies with other functional areas to drive success
• Significant experience managing clinical quality activities and in-depth knowledge of clinical operations
• Lead cross-functional projects of high complexity with cross-functional team members and represent Clinical Quality & Development Operations on other large-scale projects/initiatives.
• Executes strategy for Inspections Excellence in alignment with Clinical Quality & Development Operations (CQDO), Global Clinical Operations, and Global Medicines Development & Medical Affairs program strategy and goals
• Leads major projects in support of GCO infrastructure and makes department-wide decisions.
• Demonstrated attention to detail, accuracy, excellent review and analytical skills in a fast-paced environment.
• Expert knowledge in system/technical tools and processes.
• Results oriented
• Significant experience with line management of employees
• Excellent leadership and interpersonal skills with an ability to effectively work and problem solve within a multidisciplinary team
• Experience in collaborating and working with global and cross-functional teams
• Excellent oral and written communication skills to influence, inform, or guide others and to communicate complex concepts
• Demonstrated adaptability, flexibility, independence and resourcefulness to thrive in a mid-sized company environment
• Proven successful track record in maintaining knowledge and compliance of regulatory requirements

Education and Experience:

• Typically requires 10 years of experience, or the equivalent combination of education and experience, in the biopharmaceutical industry
• 3 years of supervisor/management experience

Pay Range:

Disclosure Statement:

Flex Designation:

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