Senior Manager Quality, Analytical and CMC

Job Description

General Summary:

The Senior 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
• Assesses and approves 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.
• Identify, facilitate, and/or lead continuous improvement efforts
• 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
• Identify and communicate risks and assist with risk mitigation plans as necessary
• Supports internal audit or external audit programs
• Assists in preparation of audit responses
• Provides technical advice for partner and regulatory agency audits
• Provides information to assist in budgeting and scheduling

Knowledge and Skills:

• Strong experience in cell and gene therapy/Biologics
• Strong CMC/Regulatory experience
• Review quality investigations /deviations and corrective/preventive action (CAPA) plans for adequacy and compliance. This includes root cause analysis and product impact assessments for investigations resulting from deviations and OOS.
• In-depth knowledge of electronic document management systems (e.g., QDoccs, Veeva)
• Assists in preparation of audit responses, BLA, MAA, IND/IMPD submissions
• Provides technical advice for partner and regulatory agency audits
• Conducts GMP document review, including procedures, work instructions, specifications, methods, protocols, and reports
• Stability experience
• Identify, facilitate, and/or lead continuous improvement efforts
• In- depth knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting; in-depth knowledge of global GMP requirements and support of GMP manufacturing
• Strong team 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 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 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

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

We’re enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid, or On-Site-Eligible role, you can choose to work:

1. On-Site and work 5 days per week with ad hoc flexibility;

2. Hybrid and work remotely up to two days per week on regularly scheduled days; or select

#LI-AR1 #LI-Hybrid

Company Information