Qa à Grande-Bretagne

About the job Associate Director, Audit Management

Job Title: Associate Director, Audit Management

Job Location: Street, UK

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level: Mid-Senior level

Job DescriptionGeneral Summary:The Audit Management Associate Director is responsible for the audit and inspection management for assigned activities, inclusive of internal and external processes. This role has responsibility for design and execution of compliance audits across GMP suppliers through the development of a risk-based audit program designed to support activities across Vertex business functions. This role ensures adherence to applicable regulations, industry standards, and to Vertex policies, procedures, and quality standards as set forth in the Quality Management System. This role may be a generalist but more often specializes in manufacturing, distribution, laboratory, or clinical practices. Regularly applies specialized domain knowledge to assignments and provides technical recommendations to management.

Key Duties And Responsibilities

• Provides Biotherapeutic and Combination Device Regulation expertise and leadership
• Contributes to the overall direction of the GMP 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 regulatory requirements, and guidance, etc.
• Partners with QA leadership and business leadership for coordination and alignment in ensuring overall quality of audit and adequacy in remediation/improvement across vendors and internal operations
• Directs the development and maintenance of the integrated and risk-based GMP 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 Global Quality Compliance to provide direction and alignment of risk-based approaches, ensuring that GMP audit strategies and processes are established to:
• 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
• Serve as 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
• May manage Audit and Inspection Management Team Members

Knowledge And Skills

• Biotherapeutics and Combination Device Regulations and current industry standards
• GMP audit processes
• GMP quality systems
• Regional/international knowledge of GMP regulations
• CMC documentation
• Investigation, root cause analysis, and effectiveness check processes, tools, and techniques
• Change management and risk management principles and process knowledge

Education And Experience

• Bachelor's degree in relevant field is required
• Typically requires 8 years of experience or the equivalent combination of education and experience
• Advanced knowledge and experience with Biotherapeutic and Combination Device requirements in applicable specialty areas such as manufacturing, laboratory, or clinical practices
• Direct industry experience with Biologics / Biotechnology / Combination Products / Parenteral Products
• Management and execution of risk-based audit program
• Health Authority Inspection Programs (Readiness/Preparation/Management)

Pay Range $149,300.00 - 224,000.00 USD annually

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.

Flex Designation Remote-Eligible

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

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