Job Description
***PLEASE SEND YOUR CV IN ENGLISH***
General position summary:
Associate Director, Regional QA Lead (LATAM & Central America) is a leader within International Quality organization who holds responsibility in ensuring quality compliance in LATAM and Central American Vertex Affiliates. This position holder has an oversight of the distribution network, including distribution partners, and will lead quality oversight initiatives associated with LATAM and Central American region. Associate Director, Regional QA Lead will also ensuring ongoing maintenance of the licenses, leading regulatory inspections, and supporting International Quality in wider regional or global projects.
This Position Reports to: Director, Market Quality
This is a hybrid role based in Sao Paulo, Brazil.
Key Responsibilities:
LATAM & Central American Regional activities:
- In cooperation with International QA teams, establish and maintain corporate quality objectives, actively promote an effective quality management system (QMS).
- Provide strategic guidance for and facilitate ongoing maintenance of processes and supporting systems.
- Act as the key liaison with Regional Business Partners in International Supply Chain and Commercial and provide strategic direction and alignment with business needs.
- Identify, assess and communicate mitigation plans for the risks determined within the region.
- Lead regional QMS harmonisation initiatives and support business partners from the QA perspective.
- Support geographical expansion activities to ensure that Quality related actions are planned into projects and completed in line with commitments.
- Oversight and maintenance of the local Drug Establishment Licenses.
- Ensure documented system is in place to support GxP compliance management both internally and externally, with all manufacturers and third parties to whom activities are delegated.
- Maintain oversight of outsourced activities and associated quality technical agreements.
- Ensure close partnership and alignment with other QA teams within Vertex in relation to product launch (process development, alignment on roles & responsibilities etc) in ensuring clear QA representation within regional affiliates.
- Support product recall and mock recall operations for Vertex LATAM and Central American sites.
- Act as the ‘go-to’ QA Subject Matter Expert.
- Maintain QA oversight of Named Patient Supply and Managed Access programs.
- Ensure QA oversight in accordance with local requirements; ensure product procurement, storage and distribution are managed in accordance with GDP requirements.
- Build effective relationships with distribution QA in order to manage issue resolution, process improvements, returns handling, KPI reporting and ensuring overall quality oversight.
- Assess the impact and approve deviations, CAPAs and Change Control related to QMS.
- In collaboration with supply chain, ensure that supply chain maps are maintained for all distribution channels.
- Manage internal audits and support external audit scheduling, scope and other qualification activities.
- Perform risk assessments relating to Distribution Partner activities.
Key technical knowledge and skills:
- Strong leadership skills with the ability to lead a team to thrive in a fast paced, evolving environment.
- Able to leverage knowledge of organisational objectives, goals and mission to shape QA initiatives.
- Takes risk-based approaches to create a variety of cost-effective solutions that ensure that compliance and business requirements are optimized.
- Broad and deep global health regulatory agency knowledge and experience across multiple GDP/GMP with current knowledge of industry trends and best practices for efficiency, compliance and effectiveness.
- Ability to recognize risks and issues impacting the budget, and develop recommendations for mitigation across scope of responsibility
- Develop and apply creative solutions that meet demands of the function
- Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence
- Work cross-functionally with all levels to foster exceptional collaboration.
- Root Cause Analysis tools/methodology
- Sense of urgency- ability to act quickly/escalation process/transparency
- Attention to detail
- Fluency in verbal and written English and Portuguese. Spanish would be a big plus.
Minimum qualifications:
Master’s degree and relevant work experience, or Bachelor’s degree in a scientific or allied health field (or equivalent degree) and significant years of relevant work experience.
Qualifications:
- Degree in pharmacy, chemistry, medicine, biology or a related life science
- GDP & GMP work experience, or relevant comparable background.
- Experienced Lead Auditor
- Proficiency in using Microsoft Office applications required (MS Word, MS Excel, MS PowerPoint)
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.
