QA Manager- External Manufacturing

2 months ago

London, United Kingdom Vertex Full time

Job Description

The Quality Assurance Operational Manager is responsible for the management and oversight of the QA batch disposition process. The role will lead QA execution activities for the review, applicable disposition and archiving of batches associated with Cell & Genetic (C&G) Therapeutic programs including review of batch data, batch records, deviations, in-process data, EM data, QC release testing and other quality systems documentation.

A key expectation is the ability to closely collaborate and build relationships with internal and external stakeholders to drive compliance and continuous improvement activities.

Key Duties & Responsibilities

  • Responsible for quality disposition execution of Cell and Gene (C&G) Therapy batches manufactured externally across clinical, launch and commercial processes including support of analytical laboratory, and manufacturing operations.
  • Responsible for GMP batch disposition activities including review and approval of batch records, deviations, in-process data, EM data, QC release testing, and other quality activities as applicable to determine acceptability of product disposition.
  • Review of QA disposition change controls, process and OOS investigations, and associated CAPAs. 
  • Responsible for approval of COAs and product labelling.
  • Support technical transfer, and Process Performance qualification batch review and disposition activities.
  • Responsible for identifying compliance risks/gaps for GMP disposition processes implementation of mitigating controls. 
  • Assist with addressing product complaints investigations related to batches.
  • 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 as determined by Management.

Required Education Level

  • Master's/Bachelor's degree in a biotech/ Lifesciences field.

Required Experience

Extensive relevant industry experience such as manufacturing, quality assurance, and/or quality control in biotechnology/regulated pharmaceutical environment.

Required Knowledge/Skills

  • Demonstrated experience providing QA support to External GMP manufacturing operation
  • Experience successfully leading event investigations, Root Cause Analysis and CAPA
  • Experience with network-based applications such as Oracle, TrackWise, Veeva
  • In-depth knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting; Biotech/Cell & Gene GMP regulations and applicability. (e.g. EU, FDA, ICH, USP, etc. or other industry best practices ex. ISPE, WHO, etc.)
  • Knowledge in Cell therapy, 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.

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

  •  Up to 15% Travel may be required

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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