Senior Manager, GMP Operational Quality

Vertex France Distribution; Boston (MA); Hybrid; USD 132,000 - 200,000; Full time

Job summary

A global biotechnology company seeks a Senior Manager for GMP Operational Quality in Boston. This role involves leading quality assurance initiatives, managing complex projects, and collaborating with various stakeholders to ensure compliance with biological and device regulations. Candidates should possess a scientific degree and relevant experience in quality management.

Benefits

Generous paid time off including company-wide shutdowns

Educational assistance including student loan repayment

Commuting subsidy and matching charitable donations

Qualifications

• Typically requires 6 years of experience, or equivalent combination of education and experience.
• In-depth knowledge of cGMPs in a biologics and devices setting.

Responsibilities

• Manage complex projects and collaborate with internal and external partners on quality issues.
• Conduct GMP document reviews and ensure compliance with quality standards.

Skills

Team Leadership

Risk Management

Quality Assurance

Education

Bachelor's degree in a scientific or allied health field

Tools

Electronic Document Management Systems

Job description

Senior Manager, GMP Operational Quality page is loaded

Senior Manager, GMP Operational Quality

Apply locations Boston, MA time type Full time posted on Posted 2 Days Ago job requisition id REQ-25674

Job Description

General Summary:

The Sr. Quality Manager is an advanced technical resource in the principles and application of quality assurance and compliance. The Sr. Quality Manager coordinates or executes activities on multiple complex projects and takes a role in the design and execution of new projects.

Key Duties and Responsibilities:

• Collaborate with internally and external business partners to resolve complex quality issues to ensure compliant solutions
• Participates in cross-functional teams as an experienced Quality technical resource
• Drafts and enforces Quality Agreements between CMOs/Suppliers and Vertex, as needed
• Assists Change Control owners with ensuring compliance to change procedure requirements
• Initiates and assesses change controls
• Conducts quality investigations /deviations and reviews corrective action plans for adequacy and compliance. This includes root cause analysis and product impact assessments for investigations resulting from deviations and OOS.
• Ensures appropriate CAPA actions are identified and addressed.
• Approves investigations/CAPAs.
• Performs review and approval of master and executed batch records to support drug substance (DS), drug product (DP), device (Autoinjector) and finished goods (FG) disposition activities
• Maintains Quality Metrics to support process improvement activities
• Provides tactics to address compliance gaps or recommends enhancements to cross-functional quality systems
• Conducts GMP document review, including procedures, work instructions, specifications, methods, protocols, and method reports
• Responsible for coordinating, facilitating and follow up on any QLT action items assigned.
• Identify and communicate risks and assist with risk mitigation plans as necessary
• Supports internal audit or external audit programs
• Provides technical advice for partner and regulatory agency audits

Knowledge and Skills:

• In- depth knowledge of both the conceptual and practical application of cGMPs in a biologics and devices pharmaceutical setting; in-depth knowledge of global GMP requirements in support of GMP manufacturing and/or device assembly
• Strong team leadership skills with the ability to work in a fast-paced environment and meet quality, accuracy, and timeliness objectives
• In-depth experience managing complex projects with contract manufacturing organizations and continuous improvement within stated objectives and timelines; effectively applies project management processes / tools to address quality initiatives in meetings, assist with planning, and facilitate completion of tasks
• Strong experience in identifying, assessing and mitigating potential risks utilizing quality risk management best practices
• Ability to mentor and guide less experienced colleagues, skilled at transferring technical 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 technical experience and 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 event investigations, Root Cause Analysis (RCA), and CAPA
• Strong experience with electronic document management systems (e.g., QDocs, Trackwise, Veeva)

Education and Experience:

• Bachelor's degree in a scientific or allied health field (or equivalent degree)
• Typically requires 6 years of experience, or the equivalent combination of education and experience

#LI-hybrid

Pay Range:

$132,900 - $199,400

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:

Hybrid-Eligible Or On-Site Eligible

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 [e-mail]

Similar Jobs (5)

Associate Director, GMP Operational Quality (Hybrid)

locations Boston, MA time type Full time posted on Posted 30+ Days Ago

Senior Director, GMP Operational Quality - Cell & Gene (Onsite)

locations Boston, MA time type Full time posted on Posted 30 Days Ago

Director, GMP Operational Quality (Onsite, Sun-Wed)

locations Boston, MA time type Full time posted on Posted 30+ Days Ago