Associate Director, Global GxP Compliance - External

Job Description

The Associate Director, Global GxP Compliance - External, as part of the Global Quality Compliance group within the Vertex Quality Assurance Organization, is responsible for overall global compliance programs and processes across GxP Vendors. This position provides compliance oversight of all GxP processes outsourced to third party vendors associated with development and commercialization of Vertex products. It includes process ownership and compliance oversight of global vendor programs including Vendor Quality Management / Standards, vendor qualification processes, vendor audit and inspection programs / systems, and lifecycle initiatives. This position provides oversight of key Vertex GxP activities regulated by international regulatory bodies, while continuing to work closely as liaisons with Quality Operations and key business partners globally for GxP external operations.

This individual will be responsible for design and execution of risk-based compliance approaches and programs related to externally executed GxP activities, assuring adherence to applicable regulations, industry standards, and to Vertex policies, procedures and quality standards as set forth in the Quality Management System. This individual will provide strategic input on execution of vendor audits and projects, identify, and communicate compliance risks, and oversee applicable risk mitigation plans. This individual will provide input and guidance in the development of Vertex's Audit plans across GxP vendors, have budget responsibilities for the qualification / requalification of vendors, and associated Global Compliance oversight of external organizations providing GxP services / execution.

Vertex is an exciting, fast paced dynamic environment with a strong company culture focused on patients with unmet medical needs. The ideal candidate is someone with experience in risk-based compliance programs and who thrives in an environment with an ability to shape an evolving compliance program in support of this expanding team.

Position may require up to 25% domestic/international travel.

Key Responsibilities:

• Support global vendor compliance programs with responsibility for operational direction, performance, and effectiveness of quality risk management/mitigation and the adequacy and adherence to controls for quality and compliance with GxP regulatory requirements and guidances.
• Partner with QA and business leadership to ensure overall health of the vendor compliance oversight program. This includes supporting Vendor Quality Management process owner network, driving process / system improvements, and evaluating key metrics / KPIs and taking action as necessary to ensure the process remains in steady state of control.
• Assist in development and maintenance of the integrated and risk based GxP Vendor Quality Management / compliance program and provides leadership in setting the direction to plan development, execution, and adherence. Partners with and engages stakeholders, Quality Operations, and leadership across functional areas and QA in risk evaluation with specific focus on auditing of internal systems.
• Advise critical compliance activities as necessary, including due diligence, integrations, mock Pre-Approval / Pre-License Inspections (PAIs / PLIs), licensing and acquisition, regulatory agency interactions, regulatory inspections, inspection readiness, recovery/remediation, decommissioning, divestiture, and critical new product strategies.
• Serve as a compliance contact for regulatory surveillance activities impacting GxP vendors by identifying, prioritizing, assessing gaps, and ensuring implementation of new and revised regulatory requirements, guidances and expectations. Also, liaise with industry organizations and workgroups to help shape regulatory landscape.
• Provide compliance oversight for GxP vendor critical investigations, escalations, health authority notifications, market action to ensure safe and effective product is supplied to the clinic / market.
• Participate and provide vendor compliance input to QLTs / Risk Register Reviews.
• Collaborate with other leaders in Global Quality Compliance department to provide operational direction and alignment of risk-based approaches, ensuring that compliance processes are established to:
  • Provide oversight, including budget forecast and tracking, for qualification/requalification activities that are outsourced.
  • Execute mock Inspections, directed or For-Cause / Directed audits, as needed.
• Engage in Preparation, Support and Follow-up activities for GxP vendor Inspection Readiness.
• Support due-diligence and business development activities, as requested.
• May serve as Quality Management System representative with respect to External/Vendor Global Compliance:
  • Actively participate in Process Operating Networks / GQC Community of Practice.
  • Participates in collaborative review of associated Standards/SOPs/WIs
  • 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.
• Provides cross-functional support across Vertex Quality Assurance team and effectively partners with key stakeholders, business partners and external organizations.
• Provides functional area support of Compliance Team Members through the execution of the following:
  • GxP Vendor compliance team engagement on strategic objectives
  • Performance Management (goals, monitoring, reviews)
  • Talent Acquisition / Recruiting / Interviewing / Selection as needed
  • Onboarding/ Transition / Succession Planning as needed
  • Oversight of day-to-day execution
  • Forecasting
  • Participation in QA Business Reviews, as required.

Minimum qualifications:

• B.S. in a scientific or allied health field and 8+ years of relevant QA and Compliance experience with GxP vendor expertise, audit program development/maintenance and execution using risk-based frameworks in GxP environment, or relevant comparable background.
• 3+ years' experience with vendor quality management

In-depth knowledge in the following areas:

• Broad knowledge and demonstrated experience with global regulatory requirements and standards/best practices in GxP regulated environments.
• Global GxP regulations, guidelines, and directives with specific focus on activities that are outsourced to third parties and relationships between Contract Giver and Contract Acceptor.
• Research & Development, Clinical and CMC activities / applications (e.g., IND, IMP, NDA, BLA, MAA, etc.)
• Third Party/Vendor Management/Quality Management
• Quality System Elements
• Deviation / OOS Investigations, Root Cause Analysis, CAPA and Effectiveness check processes, tools, and techniques
• Risk Management Principles / Risk-based Programs

#LI-remote #LI-SV1

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.

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