Job Description

The Global Quality Systems Manager is responsible for supporting the Global Quality Systems department. This includes providing project coordination on strategic initiatives and day-to-day oversight activities to ensure compliance with regulatory requirements, industry standards, and company policies.

Key Duties and Responsibilities:

• Serve as primary support and project coordinator for quality system processes and strategic initiatives, including continuous improvement of QMS-Framework, Quality Standards, Quality Risk Management, Escalation and Governance
• Collaborates with cross-functional teams to ensure timely and compliant execution of QMS / Quality Systems activities
• Supports the team in compliance related activities; may own, track and /or facilitate the completion of deviations, CAPA, inspection /audit commitments, etc.
• Analyzes QMS trends and KPIs to identify opportunities for continuous improvement
• Performs compliance and data quality checks as part of QMS oversight to ensure execution is compliant with internal procedures / regulatory requirements
• Ensure timely closure of quality records in accordance with procedural and regulatory timelines.
• Assists in authoring and revising SOPs, work instructions, and training materials
• Performs other duties as assigned

Knowledge and Skills:

• Strong knowledge of GxP regulations and concepts related to Quality Systems management.
• Experience working in a GxP regulated environment in Quality Systems, Compliance, Data Quality, Quality Operations roles
• Experience with data visualization tools
• Ability to collaborate effectively with cross-functional teams.
• Strategic, critical and analytical thinking
• Strong oral and written communication skills to explain complex information to others
• Ability to identify and independently seek out needed information
• Detail oriented, with demonstrated ability to independently plan and conduct data analysis
• Experience in project management and working with PM software
• Experience with managing CAPAs in electronic Quality Management Systems

Education and Experience:

• B.S in a scientific or allied health field (or equivalent degree)
• Typically requires 4 years of experience in the Biotech or Pharmaceutical Industry, or relevant comparable background

#LI-AR1 #LI-Remote

Pay Range:

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.

Flex Designation:

Flex 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 – you’re 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 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.

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