GMP Operational Quality Senior Specialist
Vertex Pharmaceuticals

Type of Role: Contract position, Inside IR35
Contract length: 12 months
Location: Hybrid, 3 days on site in Paddington, London (Two days working from home)
Department: Operational Area Quality

Looking for opportunities with purpose, impact and possibilities? Our client, Vertex, is a global biotechnology company that invests in scientific innovation. As they grow their pipeline at pace, they are strengthening their reputation for creating transformative medicines for people with serious diseases.

The GMP Operational Quality Senior Specialist works with a high degree of independence, while providing oversight of the development, implementation and maintenance of relevant quality initiatives in support of their function. The Senior Specialist completes work in a resourceful, self-sufficient manner and can design alternative approaches to achieve desired outcomes.
They are adept at troubleshooting problems, coordinating and executing activities on multiple complex projects ensuring alignment with corporate goals and compliance with all regulatory requirements.

Key Responsibilities:

• Perform disposition activities for Finished Goods in support of Clinical/Commercial Product, including:
  • Master and Executed Batch Record review and resolution of comments/issues.
  • Evaluations of Investigations/ OOS/ Change Controls to support Disposition Status.
  • Status change in Oracle.
  • Provide quality guidance and oversight for Exemption Management related queries.
  • QMS records review and approval (Deviation, CAPAs, Change Controls).
  • Artwork Review and Approval including Bill of Materials.
  • Archiving of batch documents in electronic document system.
  • Collaborative reviewer of internal procedures.
  • Review and approval of CMO related documents.
• Support quality oversight of artwork/label review, approval, & implementation.#
• Provides quality guidance for root-cause analysis and product impact assessment for investigations as a result of deviations, OOS, and OOT investigations ensuring appropriate CAPA actions are identified.
• Provide quality support for planning of product launches and tracking of new artworks.
• Assist in packaging validation activities as needed.
• Develops relationships with strategic external partners in support of Vertex’s expanding commercial portfolio and assist with ongoing relationships.
• QP Relationship and Release:
  • Facilitate Disposition of QP Release of finished goods.
  • Assist with QP Declaration requests.
• Collaborative reviewer of internal procedures.
• Establishment of Quality Processes/Process Ownership – Packaging /Labeling and QP Release of Finished Goods.
  • Serve as review/approver or owner of deviations.
  • Monitors and trends events and identifies/proposes corrective actions.
  • Serve as CAPA and Deviation owner.
  • Identifies risks and communicates gaps to management.
  • Assists with the generation of process related metrics/monitors for efficiency.
• Commercial Change Control.
  • Serve as QA assessor/approver: resolve gaps, approve change plans, classifications, strategy for GMP release and disposition strategy.
• Maintain batch disposition spreadsheets, input data and extract metrics.

• Relevant science degree.
• Knowledge of global GMP/GDP requirements governing oral drug products including exemption management and non-licence supply.
• Batch release experience is required.
• Knowledge of packaging and labelling process and artwork requirements.#
• Investigation and Root Cause Analysis tools/methodology.
• Working with external CMOs is preferred.
• Audit process understanding.
• Ability to assess when to escalate urgent requests.
• Ability to take ownership and accountability for shared information.
• Good communication skills and ability to engage with internal and external stakeholders.
• Demonstrated ability to work independently to provide QA support for relevant projects.
• Skilled in creating and maintaining spreadsheets in Excel, including the use of formulas and macros.
• Able to adapt in a fast-paced environment .