Sr. Quality Manager

Job Description

General Summary:

The Market Quality Senior Manager for Brazil & Southern LATAM ensures quality compliance oversight of the distribution network in Southern LATAM (Brazil local affiliate, Argentina, Chile, Paraguay and Uruguay), including distribution partners from these countries and will lead quality initiatives associated with local affiliate and the region. This role supports commercial activities related to GDP, GMP and geographic expansion, and participates in regulatory inspections covering GDP and GMP (as required). The role also acts as the Local Responsible Person (RP/QP) for the Brazil Vertex Affiliate.

This position reports directly to: Associate Director Market Quality LATAM

Key Duties and Responsibilities:

• Collaborate with internally and external business partners to resolve complex quality issues to ensure compliant solutions

• Participates in cross-functional teams as an experienced Quality technical resource

• Drafts and enforces Quality Agreements between CMOs/Suppliers and Vertex, as needed

• Assists Change Control owners with ensuring compliance to change procedure requirements as well as assesses and approves change controls

• Conducts quality investigations /deviations and reviews corrective action plans for adequacy and compliance. This includes root cause analysis and product impact assessments for investigations resulting from deviations and OOS

• Ensures appropriate CAPA actions are identified and addressed as well as approves investigations/CAPAs

• Identify, facilitate, and/or lead continuous improvement efforts

• Provides tactics to address compliance gaps or recommends enhancements to cross-functional quality systems

• Conducts GMP document review, including procedures, work instructions, specifications, methods, protocols, and method reports

• Responsible for coordinating, facilitating and follow up on any QLT action items assigned.

• Identify and communicate risks and assist with risk mitigation plans as necessary

• Manage internal audits and support external audit scheduling, scope and other qualification activities. And support Inspection preparation and management, prior to, during and following any Competent Authority inspection of local and regional locations.

• Provides technical advice for partner and regulatory agency audits

• Provides information to assist in budgeting and scheduling

• In cooperation with International QA teams, establish and maintain corporate quality objectives, actively promote an effective quality management system (QMS) ensuring documented system is in place to support GxP compliance management both internally and externally, with third parties to whom activities are delegated.

• Serve as local QP/RP quality representative to ensure QMS and licences accurately reflect current operations and update as necessary ensuring Sanitary Compliance/ notification of operation.

• Ensure QA oversight in accordance with local requirements; ensure product procurement, storage and distribution are managed in accordance with GDP requirements.

• Maintain effective relationships with distribution QA in order to manage issue resolution, process improvements, returns handling, KPI reporting and ensuring overall quality oversight in Southern LATAM

• Support Inspection preparation and management, prior to, during and following any Competent Authority inspection of international locations; Support manufacturing locations as required. Ability to support regulatory inspections and interact directly with health authorities.

• Experience with any or all the following, is a definite plus: Supplier qualification, batch disposition, leading investigations, regulatory submission review and support, root cause analysis tools/methodology. 

• Act as Responsible Person (Technical Responsible) for Brazil Affiliate as required in line with the requirements of the regional/market Good Distribution Practices and Vertex Procedures. 

Knowledge and Skills:

• In- depth knowledge of both the conceptual and practical application of cGMPs/cGDPs in a pharmaceutical setting

• Strong team leadership skills with the ability to work in a fast-paced environment and meet quality, accuracy, and timeliness objectives

• In-depth experience leading complex projects and continuous improvement initiatives within stated objectives and timelines; effectively applies project management processes / tools to lead meetings, assist with project planning, and facilitate completion of tasks

• Ability to independently lead cross-functional teams and represent the Quality unit

• Ability to mentor and guide less experienced colleagues, skilled at transferring technical knowledge and teaching quality management skills

• Ability to communicate cross-functionally to a wide variety of audiences; exchanges complex and sensitive information and can influence others to understand a point of view and gain alignment around a proposed action

• Demonstrated ability to work independently to provide QA advice for large, multifaceted projects

• Demonstrated ability to evaluate quality matters and make complex decisions leveraging technical experience and advanced judgement and the analysis/synthesis of a variety of information; able to work outside of precedent and takes a new perspective on existing solutions

• GDP & GMP work experience, or relevant comparable background.

• Able to demonstrate technical knowledge in areas of legislation governing storage and distribution of human medicinal products.

• Ability to apply knowledge about the functional areas of the organisation, and advocate for and represent Market Quality when working with stakeholders.

• Ability to evaluate quality matters and make decisions utilizing risk-based approach.

• Analytical thinking / Data Analysis/ Attention to detail/ Sense of urgency- ability to act quickly/escalation process/transparency/Critical thinking / Problem solving / decision making.

• Skilled at time and resource management and prioritization, planning and organization skills.

• Proficiency in using Microsoft Office applications required (MS Word, MS Excel, MS PowerPoint), considering a plus Track wise and Veeva system.

• Fluency in verbal and written English and Spanish

Education and Experience:

• Bachelor's degree in a scientific or allied health field (or equivalent degree) with experience releasing and supporting local Legal representative responsibilities

• Registration with an appropriate professional body may also be required under local national law.

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.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Hybrid

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