Senior Manager, Quality Operations Cell and Gene (Hybrid)

Job Description

General / Position Summary

The Quality Assurance Senior Operational Manager is recognized as an expert internally in the principles and application of quality assurance and compliance.

The Quality Snr Manager will provide QA support of manufacturing operations, analytical laboratory operations and materials management for the external manufacture of Cell & Genetic Therapeutic programs.

This role will drive, review & support activities related to product disposition including review of batch data, batch records, deviations, in-process data, EM data, QC release testing and other quality systems documentation.

Key Duties & Responsibilities

• Responsible for quality support of Vertex Cell and Gene Therapy manufacturing operations across all phases of development, support of analytical laboratory, materials management and manufacturing operations.
• Ability to gather and analyze large sets of manufacturing / operations date and create data visualizations using industry standard tools.
• Using standard statistical techniques and data visualization tools to identify trends, patterns, and correlations.
• Stakeholder collaboration :
• Working with business stakeholders to understand their data needs and provide actionable insights.

Responsible for GMP batch disposition activities including review and approval of batch records, deviations, in-process data, EM data, QC release testing, materials review board and other quality activities as applicable to determine acceptability of product disposition.

Partner with External CDMOs located in Netherlands and other EU locations

Provide QA support of change controls, process and OOS investigations, and associated CAPAs.

Responsible for approval of COAs and product labelling.

Review and approval of manufacturing documents such as technical and analytical protocols / reports

Support technical transfer, and Process Performance qualification activities.

Responsible for identifying compliance risks and gaps for GMP processes and supporting implementation of mitigating controls

Support audit and inspection readiness activities.

Act as a trusted advisor by providing compliance guidance through collaborative review and partnering with business stakeholders and contract manufacturers.

Support the vendor management process including the creation and review of Quality Agreements with suppliers.

Assist with addressing product complaints

Maintain periodic batch record metrics and assists department with routine / quarterly Quality System data review metrics and reporting

Lead and participate in Cell & Genetic Program and Quality projects and drive continuous improvement activities.

Required Knowledge / Skills

Bachelor's degree in a biotech / Lifesciences field.

Demonstrated experience providing QA support to GMP manufacturing operation

Experience successfully leading event investigations, Root Cause Analysis and CAPA

Experience with network-based applications such as Oracle, TrackWise , Veeva

I n-depth knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting; Biotec / Cell & Gene GMP regulations and applicability.

e.g. EU, FDA, ICH, USP, etc. or other industry best practices ex. ISPE, WHO, etc.)

K nowledge in AAV / Cell technology, aseptic manufacturing technology, analytical assays, cell & genetic therapies / Biologics processing, fill / finish and testing.

Professional membership or equivalent in relevant societies, network of knowledge in cell and gene therapy industry.

Ability to evaluate quality matters and make decisions utilizing risk-based approach

Ability to independently lead cross-functional teams, and effectively communicate with business stakeholders.

Ability to travel to our CDMO partners on site in Europe , up to 40% travel may be required .

Hybrid-Eligible Roles

In this Hybrid-Eligible role, you can choose to be designated as :

Hybrid : work remotely up to two days per week; or select On-Site : work five days per week on-site with ad hoc flexibility.