External Manufacturing Quality Assurance Lead

3 weeks ago

London, Greater London, United Kingdom Vertex Full time

Job Overview

The Quality Assurance Operational Manager plays a crucial role in overseeing the QA batch disposition process. This position is responsible for leading QA activities related to the review, appropriate disposition, and archiving of batches associated with Cell & Gene (C&G) Therapeutic programs. This includes the examination of batch data, records, deviations, in-process data, environmental monitoring data, QC release testing, and other quality documentation.

A significant expectation is the ability to collaborate effectively and foster relationships with both internal and external stakeholders to promote compliance and drive continuous improvement initiatives.

Key Responsibilities

  • Oversee quality disposition execution for Cell and Gene (C&G) Therapy batches produced externally, supporting clinical, launch, and commercial processes, including analytical laboratory and manufacturing operations.
  • Manage GMP batch disposition activities, which involve reviewing and approving batch records, deviations, in-process data, environmental monitoring data, QC release testing, and other quality-related tasks to assess product acceptability.
  • Evaluate QA disposition change controls, process deviations, and out-of-specification (OOS) investigations, along with associated corrective and preventive actions (CAPAs).
  • Authorize Certificates of Analysis (COAs) and product labeling.
  • Support technical transfers and conduct reviews of Process Performance Qualification batches.
  • Identify compliance risks and gaps in GMP disposition processes and implement necessary controls.
  • Assist in the investigation of product complaints related to batches.
  • Maintain periodic metrics for batch records and assist the department with routine and quarterly reviews of Quality System data and reporting.
  • Lead and engage in Cell & Gene Program and Quality projects as directed by management.

Required Education

  • Master's or Bachelor's degree in a biotech or life sciences field.

Required Experience

Extensive relevant experience in manufacturing, quality assurance, and/or quality control within a biotechnology or regulated pharmaceutical environment.

Required Knowledge and Skills

  • Proven experience providing QA support to external GMP manufacturing operations.
  • Demonstrated ability to lead event investigations, conduct Root Cause Analysis, and manage CAPA processes.
  • Familiarity with network-based applications such as Oracle, TrackWise, and Veeva.
  • Comprehensive understanding of cGMPs in a pharmaceutical context, including Biotech/Cell & Gene GMP regulations and best practices (e.g., EU, FDA, ICH, USP, ISPE, WHO).
  • Knowledge of cell therapy, aseptic manufacturing technologies, analytical assays, and the processing of cell & genetic therapies/Biologics.
  • Membership in relevant professional societies and a network of knowledge in the cell and gene therapy sector.
  • Ability to assess quality issues and make informed decisions using a risk-based approach.
  • Capacity to independently lead cross-functional teams and communicate effectively with business stakeholders.

Other Requirements

  • Willingness to travel up to 15% may be necessary.

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.

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