Associate Director, Audit Management - Medical Device (Remote)
Associate Director, Audit Management - Medical Device (Remote)
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Job Description
Job Description
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 Medical Device/Combination Product 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
Travel Requirements:
Up to 30% Domestic / International Travel
Knowledge and Skills:
Advanced/specialized and in-depth knowledge of:
Medical Device/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:
Bachelors degree in relevant field is
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 Medical Device/Combination Products
Management and execution of risk-based audit program
Health Authority Inspection Programs (Readiness/Preparation/Management)
#LI-AR1 #LI-Remote
Pay Range:
$149300 - $224000Disclosure Statement:
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.
At Vertex our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career financial family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter) educational assistance programs including student loan repayment a generous commuting subsidy matching charitable donations 401(k) and so much more.
Flex Designation:
Remote-EligibleFlex 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 youre 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 Vertexs 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 persons 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
Required Experience:
Director
Employment Type
Full-Time
