- 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
- Manage outsourced audits
- Enable the execution of GxP vendor qualification and requalification audits
- Conducts audits of GxPs for CxOs (the role will have a specialist focus on GMP and GDP)
- Engages in preparation, support, and follow-up activities for inspection readiness
- Provides regulatory compliance support to cross-functional teams as requested
- Serves as GxP quality management system resource
- 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
- Provides cross-functional support across the QA team
- Reviews and analyzes key performance indicator data and trends
- Analyzes risk and proposes remedial, corrective and /or preventive actions
- Domestic and international travel required 25-50%
- Specialized, thorough knowledge of:
- Good GxP Auditing Practices
- GxP audit processes
- GxP quality systems
- Regional/international knowledge of GxP regulations
- CMC documentation
- Investigation, root cause analysis, and effectiveness check processes, tools, and techniques
- Change management and risk management principles and process knowledge
- Bachelor's degree in a relevant field is required
- Typically requires 6 years of 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
- Experience as a lead auditor
-
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Manager, Audit and Inspection Quality Assurance - Boston, United States - Vertex Pharmaceuticals
Description
Job DescriptionGeneral Position Summary:
The Audit and Inspection Management 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, on-site and remote inspection support, and overall conduct of inspections.
This role has responsibility for design and execution of compliance audits across GxPs, CxOs, suppliers, vendors 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 Duties and Responsibilities:
Knowledge and Skills:
Education and Experience:
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.
#LI-ND2 #LI-RemotePay Range:
$115,120 - $172,680
Disclosure 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.
Company InformationVertex 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
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