Senior Manager, ATC Quality Operations, Cell and Genetic Therapies (Contract) 25075

General/Position 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.

The successful applicant will perform quality risk assessments and assist with completion of quality agreements, provide operational support for commercial site selection and activation of apheresis and cell-therapy laboratory centers. This role will be supporting the activation of the Authorized Treatment Centers (commercial sites) and will work closely with the Apheresis and Infusion Operations team and the QA Audit team in qualifying sites partnering to provide lifesaving cell and gene therapy to patients in need.

This individual is expected to demonstrate success in engaging teams and stakeholders for collaboration in advancing quality outcomes and operational excellence through business and Quality. The Senior Quality Manager is responsible to support real time treatment center assessment activities within VCGT Quality. The Senior Quality Manager will utilize their technical expertise to optimize interdisciplinary understanding and synergy with the group and integrate activities with other departments to shape a cohesive environment. This role will be remote or hybrid, but with travel and some office presence and responsibilities necessary.

The ideal candidate will  have experience working with treatment centers, vendor management, evaluating risk and negotiating contracts.

*** French speaking candidate and FACT accreditation a plus ***

Key Duties & 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 ATC/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 GXP 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
• Assists in preparation of audit responses
• Conducts treatment center Audits where required
• Manages audit CAPAs & metrics
• Provides technical advice for partner and regulatory agency audits
• Provides information to assist in budgeting and scheduling

Required Education Level

·       Bachelor's degree in a scientific or allied health field (or equivalent degree)

Required Experience

·       6+ years of experience, or the equivalent combination of education and experience

Required Knowledge/Skills

• In depth Tissues and Cells regulatory knowledge
• 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
• Strong experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA
• Strong experience with electronic document management systems (e.g., QDoccs, Trackwise,Veeva)

Other Requirements
Indicate required certifications, licenses, or specialized trainings.