Quality Systems Manager - Biologics & Device Team (Hybrid)

Job Description

General Summary:

The Quality Systems Managerserves as a senior technical expert in the principles and application of quality assurance and compliance within a regulated environment. This role leads and supports cross-functional quality initiatives, drives continuous improvement, and ensures robust compliance across Quality Systems. The Quality Systems Manager may also lead and mentor a team to execute department and business objectives.

Key Duties and Responsibilities:

• Collaborate with internal stakeholders and external partners to resolve quality issues and deliver compliant, risk-based solutions.
• Identify and lead initiatives to close compliance gaps and strengthen cross-functional Quality Systems.
• Act as a subject matter expert and Quality representative on cross-functional teams and projects.
• Lead and/or review quality investigations and deviations, including root cause analysis, product impact assessments, and corrective/preventive action (CAPA) planning.
• Approve quality events such as deviations, CAPAs, and change controls, as appropriate.
• Drive and support continual improvement initiatives across the organization.
• Manage and maintain Quality System performance metrics; analyze trends and recommend improvements.
• Support and conduct risk assessments in alignment with the risk management program.
• Perform comprehensive GMP document reviews, including SOPs, work instructions, specifications, test methods, protocols, and reports.
• Coordinate and track Quality Leadership Team (QLT) action items.
• Identify and communicate quality and compliance risks, and support risk mitigation strategies.
• Lead or support internal and external audits, including regulatory and partner inspections.
• Support audit preparation, execution, and response activities.
• Provide subject matter expertise during regulatory inspections and partner audits.
• Support people development initiatives, including coaching, mentoring, and performance feedback.

Knowledge and Skills:

• In-depth knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical or medical device setting
• Strong team leadership skills with the ability to work in a fast-paced environment and meet quality, accuracy, and timeliness objectives
• Ability to independently lead cross-functional teams and represent the Quality unit
• Ability to mentor and guide staff, skilled at transferring technical knowledge and teaching quality management skills
• Strong communication and interpersonal skills, with the ability to influence and align diverse stakeholders
• Demonstrated ability to manage teams and to develop personnel
• Strong experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA
• Strong experience with electronic document management systems (e.g., Veeva)
• High attention to detail, organization, and time management.

Education and Experience:

• Bachelor's degree in engineering or science
• Typically requires 5 years of experience, or the equivalent combination of education and experience.
• Experience in one or more of the following: pharmaceuticals, medical devices, combination products, Companion Diagnostics, or Software as a Medical Device (SaMD)
• Familiarity with one or more of the following regulations ( 21 CFR 210/211, or 820; ISO 13485, and EU MDR/IVDR.

#LI-hybrid #LI-JS1

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. 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