Senior Quality Specialist...

Job Description Company Name: Vertex Pharmaceuticals
Type of Role: Contract position, Inside IR35 Contract length: 12
months Location: Hybrid (3 days on site in Paddington) Department:
Market 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 Senior Quality Specialist (Contractor) role supports Market
Quality and is recognized as an expert internally in the principles
and application of quality assurance and compliance. This role
supports GDP operations for all distribution activities within the
global distribution network; key stakeholders include Operations
QA, International Supply Chain, logistics, Geographic expansion in
particular support to LATAM market quality & EEMEA (Eastern
Europe, Middle East and Africa), QMS QA, Vendor Management &
AIM QA. Key Responsibilities: - Take ownership and provide support
on QMS processes (Deviations, CAPA & Change Controls) including
Root Cause Analysis, Risk Assessment, Action completion, and timely
closure of records. - Support the intake, triage, and logging of
deviations & distribution complaints into the Veeva electronic
Quality Management System (VeeQMS). - Liaise with relevant
stakeholders to obtain full information to initiate investigation
and root cause analysis as per Vertex procedures. Track completion
and closure in a timely manner. - Prepare materials for distributor
sites to monitor performance on deviations, cascade information and
follow up on outstanding items. - Support both LATAM & EEMEA MQ
team with distributor meetings and related support – - Including
distributors KPIs and follow up and close out of action items -
Creating list of actions for both external action items
(distributors) - Veeva actions and related follow ups to close
actions on time - Support MQ with SOP processing through Veeva -
Follow up actions linked to distributor gap assessment - ~50% time
dotted line to Associate Director, Market Quality LATAM - Raise
risks/issues with timelines and seek support in timely resolution.

• Support change control records as required and complete any
  quality actions assigned. - Prepare relevant QMS data reports/KPIs
  on Deviations, CAPA, Change Controls and Effectiveness checks, for
  Affiliate QMRs, inspections, ad hoc data requests and other
  governance meetings. - Support creation of, and update to, Quality
  Agreements with Vertex Affiliates and external vendors by; drafting
  using global templates, collation and amendment based on review
  comments, collection of approval signatures via DocuSign &
  upload to the VeeDMS system. - File quality records according to
  Vertex records retention policy and procedures. - Support internal
  audit or external audit programs and inspection readiness
  activities as well as tracking post-inspection readiness. - Support
  GDP operational quality in gathering relevant documentation for
  disposition on temperature excursions. - Support Self-Inspections,
  preparation, performance, and closure of deficiencies identified. -
  Management of International Quality inbox (intake, triage, and
  timely responses to QA queries). - Support the Responsible Person
  in the fulfilment of responsibilities associated with the license.
  Minimum qualifications / SKILLS: - Bachelor's Degree, preferably in
  life sciences or technical discipline - Demonstrated experience
  with handling compliance issues, resulting from deviations or
  product defects. - Excellent organisational and time management
  skills and able to demonstrate flexibility and adaptability. - Able
  to prioritise workload, decisive thinker able to work within agreed
  timescales. - Proactive approach and strong critical thinking
  skills. - Excellent verbal and written communication skills with
  high Level of attention to detail. - Utilises available digital
  tools and systems to enhance QA performance and efficiency. -
  Knowledge of International GDP regulations. - Ability to
  collaborate cross-functionally across all levels of the
  organization. - Ability to drive results. - Continuous Process
  improvement mindset. Preferred Qualifications: - Degree in
  pharmacy, chemistry, medicine, biology, or a related life science -
  GDP & GMP work experience, or relevant comparable background. -
  Experience with processing deviations and CAPA in an electronic QMS
  tool such as Veeva or equivalent. - Knowledge of EU Good
  Distribution Practices and/or Good Manufacturing Practices and the
  applicable GxP regulations and standards. - Fluency in English is
  required - Resident in UK - Proficiency in using Microsoft Office
  applications required (MS Word, MS Excel, MS PowerPoint) Vertex is
  partnering with Talent Works to manage their international
  temporary job openings. If you are successful in your application,
  you will be employed by Talent Works to work on a temporary
  assignment at Vertex.