Type of Role: Contract position, Inside IR35 
Contract length: 12 months 
Location: Sao Paulo
Department: GDP 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.  

General Summary:

The GDP Operational 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, QMS QA, Vendor Management & AIM QA. 

Key Duties and Responsibilities:

The responsibilities of this position may include, but are not limited to, the following:

• 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 LATAM 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
• 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.

Knowledge and 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 Qualification:

• 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 LATAM Countries Good Distribution Practices and/or Good Manufacturing Practices and the applicable GxP regulations and standards.
• Fluency in English and Spanish are required
• Resident in São Paulo, Brazil
• Proficiency in using Microsoft Office applications required (MS Word, MS Excel, MS PowerPoint)