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Salary Job Description
12 month FTC
Remote
Role includes 25% International and US travel to conduct audits and inspection activities
General position summary:
The Audit Management Senior Manager is responsible for the execution of audit and inspection management assigned activities, inclusive of internal and external processes, contributing to and executing audit plans, supporting inspection readiness activities, and managing HA inspections. This role has responsibility for design and execution of compliance audits across GxPs, CxOs, suppliers and/or distributors 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.
Key Responsibilities:
- Contributes to the overall direction of the GxP audit program, performance, and effectiveness in assuring quality risk management/mitigation and the adequacy and adherence to controls for quality and compliance with GxP regulatory requirements, and guidance
- Develop, maintain and execute against audit plans
- Partners with and engages stakeholders and leadership across functional areas and QA in risk evaluation when determining the internal audit schedule
- Manage outsourced audits
- Enable the execution of GxP vendor qualification and requalification audits and mock inspection activities
- Conducts internal and vendor audits of GxPs for CxOs, suppliers and/or distributors
- Engages in preparation, support, and follow-up activities for inspection readiness
- Provides regulatory compliance support to cross-functional teams as requested
- Participates in collaborative review of impacted procedures, standards, and other documents
- Reviews and analyzes key performance indicator data and trends
- Analyzes risk and proposes remedial, corrective, and/or preventive actions
- Provides cross-functional support across the QA team
- Identifies and communicates risks
- Analyzes risk and proposes remedial, corrective and /or preventive actions
- Supports risk mitigation plan development and execution
- Supports due-diligence and business development activities, as requested
- Provides cross-functional support across Vertex Quality Assurance team and effectively partners with key stakeholders, business partners and external organizations
In-depth knowledge in the following areas:
- Good GxP Auditing Practices / GxP audit processes (focus on GMP/GDP)
- GxP quality systems
- Regional/international knowledge of GxP regulations
- CMC Manufacturing / Documentation (e.g., NDA, BLA Submissions)
- Investigation, root cause analysis, and effectiveness check processes, tools, and techniques
- Change management and risk management principles and process knowledge
- Global GMP regulations; 21 CFR Parts 210/211/610/820/11/1271 and applicable FDA guidelines, ICH guidelines, EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines / Annexes, and applicable international equivalents
- Deviation / OOS Investigations, Root Cause Analysis, CAPA and Effectiveness check processes, tools, and techniques
- Risk Management Principles / Risk-based programs
- Process Validation and Continuous Process Verification
- Contamination Control Strategies
- Strong leadership skills with the ability to work in a fast-paced environment and meet quality, accuracy and timeliness objectives
- In-depth experience leading complex projects/teams and continuous improvement initiatives within stated objectives and timelines; effectively applies project management processes / tools to lead meetings, assist with project planning, and facilitate completion of tasks
- Ability to independently lead cross-functional teams and represent the Quality unit
- Ability to mentor and guide staff, skilled at transferring knowledge and teaching quality management skills
- Ability to communicate cross-functionally to a wide variety of audiences; exchanges complex and sensitive information and is able to influence others to understand a point of view and gain alignment around a proposed action
- Demonstrated ability to work independently to provide QA advice for large, multifaceted projects
- Demonstrated ability to evaluate quality matters and make complex decisions leveraging experience, advanced judgement, and the analysis/synthesis of a variety of information; able to work outside of precedent and takes a new perspective on existing solutions
- Strong experience successfully leading GxP audits and hosting health authority inspections
- Strong experience with electronic document management and quality management systems (e.g., Veeva)
Education, Experience and Requirements:
- Bachelor's degree in a relevant field is required
- Relevant QA and Compliance experience or the equivalent combination of education and experience
- Experience as GxP generalist or in applicable specialty area such as manufacturing, distribution, laboratory, or clinical practices
- Knowledge of cGMP and GDP requirements governing oral drug products manufacturing and distribution practices
- Strong experience as a lead auditor (certified auditor status preferred)
- Ability to travel 25% to conduct audits and support inspection activities
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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.
