Assoc Director Computerized Systems Audit and Inspection Management

Recruiter
Vertex Pharmaceuticals Inc
Location
Boston, Massachusetts, United States
Salary
Competitive salary
Posted
03 Dec 2020
Closes
04 Dec 2020
Ref
REQ-10349
Experience level
Director
Job Description

General position summary:
The Associate Director of Computerized Systems & Data Integrity Audit and Inspection Management, as part of the Vertex Quality Assurance Organization is responsible for the audit and inspection management related to computerized systems and data integrity audit activities across Vertex regulated business functions. This individual will have responsibility for design and execution of Computerized Systems & Data Integrity audits across Vertex systems, conducted both internal to Vertex and at their respective vendors, in assuring adherence to applicable regulations, industry standards, and to Vertex policies, procedures and quality standards as set forth in the Quality Management System.. The Associate Director of Computerized System & Data Integrity Audit and Inspection Management will provide strategic input and execution of computerized system/data integrity audits and projects; identify and communicate compliance risks; and oversee applicable risk mitigation plans. The role also includes representation to interdepartmental teams advising teams of computerized system/data integrity Audit outcomes. This individual will provide input and guidance in the development of Vertex's Audit plans across all GxP regulated areas. Vertex provides 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 audit programs, specifically focused on computer system/data integrity audits and who thrives in an environment with an ability to shape an evolving audit program in support of this expanding team.
Position may require up to 30% domestic/international travel.

Key Responsibilities:
  • Contributes to the overall strategic direction of the Computerized System/Data Integrity audit program, performance and effectiveness of the audit program in assuring quality risk management/mitigation and the adequacy and adherence to controls for quality and compliance with Computerized System/Data Integrity regulatory requirements (and guidance's, etc.)
  • Partners with QA leadership (e.g. QA Vendor Management ,Computer Systems QA, Operational Area QA) and business leadership for coordination and alignment in ensuring overall quality of audit and adequacy in remediation/improvement across vendors and internal operations (e.g. audit planning, review of audit outcomes, and corrective/preventive action development and implementation)
  • Directs the development and maintenance of the integrated and risk-based Computerized System/Data Integrity Audit Plan and provides leadership in setting the direction to plan development, execution and adherence. Partners with and engages stakeholders and leadership across functional areas and QA in risk evaluation when determining the internal audit schedule.
  • Collaborates with other leaders in Audit and Inspection Management to provide strategic direction and alignment of risk-based approaches, ensuring that Computerized System/Data Integrity audit strategies and processes are established to:
    • Enable the execution of Computerized System/Data Integrity Vendor qualification and requalification audits
    • Provide oversight, including budget forecast and tracking, for audits that are outsourced
    • Execute directed or For-Cause audits, as needed
  • Engages in Preparation, Support and Follow-up activities for Inspection Readiness
  • Supports due-diligence and business development activities, as requested
  • May serve as Computerized System/Data Integrity 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
  • Provides cross-functional support across Vertex Quality Assurance team
  • Provides functional area leadership and management of Computerized System/Data Integrity Audit and Inspection Management Team Members through the execution of the following:
    • Performance Management (goals, monitoring, reviews)
    • Employee Learning and Development (Identification of training needs and support of aspirational goals via IDP)
    • Talent Acquisition/ Recruiting/Interviewing/ selection
    • Onboarding/ Transition/Succession Planning
    • Oversight of day to day execution
    • Forecasting
    • Participation in QA Business Reviews, as required
Minimum qualifications:
  • M.S. (or equivalent degree) and 7+ years of relevant work experience, or
  • B.S. in a scientific or allied health field and 10+ years of relevant Computer System and CMC QA audit program development/maintenance and execution using risk frameworks in the regulatory compliance environment, or relevant comparable background.
  • 5+ years' experience in a Quality Management role

In-depth knowledge in the following areas:
  • GMP/GDP Audit processes
  • GMP/GDP Quality Systems
  • Global GMP regulations (US/EU etc.); 21 CFR Part 210/211, ICH guidelines and high-level knowledge of 21 CFR Part 11, Annex 11, and International equivalents as necessary
  • Computerized Systems, e.g., SDLC process and the components of Data Integrity, e.g., ALCOA+, all in a GxP environment
  • CMC Documentation (e.g., NDA Submissions.)
  • Investigation, Root Cause Analysis, CAPA and Effectiveness check processes, tools, and techniques
  • Risk management principles and process, change management

Highly Desired:
  • GAMP, 21 CFR 600, 601, 610 in depth knowledge
  • ATMP guidelines working knowledge
Experience acting as Regulatory Inspection Host, Back-Room support and/or SME

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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.