Regional Quality Manager

4 semanas atrás

Sao Paulo, Brasil Knight Therapeutics Brasil Tempo inteiro

The Regional Quality Performance Manager is responsible for managing the quality activities related to two key areas: the Performance of Knight Quality Management System and local quality operations of Argentina, Chile, and Mexico. Ensure full compliance with all local GMP regulations and corporate policies and act as the main contact person accountable for quality activities in the affiliates.


  • Lead development, maintenance, and continuous improvement of QMS, ensuring compliance, enabling consistency across regions, and leveraging global expertise.
  • Partner with regions to operationalize the global suppliers.
  • Oversees Quality KPI


The ideal candidate is highly organized, details oriented, has good communication capabilities, technical knowledge in quality assurance, quality control, validations, and quality systems; demonstrate good problem-solving skills and can adapt to priorities changes.


PRINCIPAL FUNCTIONS

  • Being responsible for the Quality Performance of Knight Quality Management System in cooperation with international QA Teams, establish and maintain corporate quality objectives, actively promote an effective quality management system (QMS).
  • Lead all the quality team responsible for the Global Quality Systems and local quality operations of the in-license and imported products commercialized in Argentina, Chile, and Mexico.
  • 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.
  • Act as a key liaison with Regional Business Partners in International Supply Chain and Commercial and provide strategic direction and alignment with business needs.
  • Act as the Lead of Global Suppliers Qualification planning and executing the Knight annual audits.
  • Implement internal processes for the development of the people of Quality department.
  • Ensure the quality team have all the capabilities required to be compliant to the concepts of Pharmaceutical Quality Systems ICH Q10 and local GMP regulations.
  • Evaluate processes, results, operations, and trends to ensure compliance with local and international standards related to GMP, GLP, GDP. GSP, GPP
  • Manage all QMS activities: document management, training, change control, deviations, CAPAs, supplier qualification, risk management, complaints, batch release, OOS, stability studies, physical chemical and micro tests, qualifications, and validations, APQR, quality agreements, internal audits.
  • Manage quality activities done by local service providers.
  • Maintaining Sites licenses, preparing related amendments and notification to Health Authority.
  • Manage quality activities of on-site audits. Spearheading GMP audits.
  • Conducting inspections of suppliers involved in the manufacturing and/or distribution of products.
  • Manage compliance matters raised internally, by suppliers or corporate partners.
  • Manage any required product recall procedure as per internal SOPs.
  • Lead quality activities to the preparation of CTD modules or responses related to the Chemistry and Manufacturing component of a regulatory dossier for future submission.
  • Create, manage, and review quality KPIs and reports and implement actions to meet the company year objectives.
  • Being responsible for the implementation of the Quality Management System (software QMS) acting as a “go-to” QA Subject Matter Expert.
  • Assure appropriate escalations and notifications to line management.
  • Provide Quality leadership for territory expansion and new product introduction locally.


Required for the Function

  • B.Sc, M.Sc or PhD in Pharmacy
  • Other health sciences graduation can be considered.
  • Language Skills: Spanish fluent, English fluent

Required

  • 10 years within the pharmaceutical industry and acting on Quality activities.
  • Strong knowledge of Microsoft Office Suite
  • Strong Experience in People Management.
  • Ability to influence senior management and other colleagues without direct report lines.
  • Ability to work in a dynamic environment and to constantly redefine priorities according to the company’s business.
  • Strong management and leadership ability.
  • Strong knowledge of the Local regulations and good ability to interpret policies and guidelines.
  • Strong knowledge on aseptic process, clean areas, oral solid and liquid pharmaceutical products manufacturing.
  • Knowledge on analytical method transfer, research.

  • Quality Manager Regional Distribution

    Há 1 mês

    Sao Paulo, Brasil AstraZeneca Tempo inteiro

    AstraZeneca is one of the most fascinating biopharmaceutical companies in the world. From researchers to sales people, from lab technicians to the legal department, we all have a mission to turn ideas into science, science into revolutionary medicines that save and extend patients’; lives and benefit society. Our portfolio is solid and our pipeline is...

  • Regional Quality Systems

    Há 1 mês

    Sao Paulo, Brasil Kenvue Tempo inteiro

    **Regional Quality Systems & Compliance Manager | Latin America**-2307007293W Description **Kenvue is currently recruiting for Regional Quality Systems & Compliance Lead, Latin America. **This position reports into Head of Quality, Latin America and is part of the Regional Quality Leadership Team. The position can be based at Sao Jose dos Campos, Brazil -...

  • Latam Quality Manager

    Há 3 dias

    Sao Paulo, Brasil CSL Behring Tempo inteiro

    Our affiliate in Brazil was established 2 years ago and we want to strengthen our Quality Department with a Quality Assurance Specialist. In this new position, you will be in charge of expanding our Quality Management System and supporting projects of LATAM Regional office. Your tasks will be divided 70% for Brazil affiliate and 30% for the LATAM Regional...

  • Site Quality Manager

    2 semanas atrás

    Sao Paulo, Brasil Microsoft Tempo inteiro

    Microsoft’s mission is to empower every person and every organization on the planet to achieve more. As employees we come together with a growth mindset, innovate to empower others, and collaborate to realize our shared goals. Each day we build on our values of respect, integrity, and accountability to create a culture of inclusion where everyone can...

  • Regional Account Manager

    Há 1 mês

    Sao Paulo, Brasil HAYS Tempo inteiro

    Buscamos um Regional Account Manager para atuar em empresa do se, localizada em São Paulo. Como Regional Account Manager, você será responsável por desenvolver pipeline e prospectar novos clientes no mercado de Cybersecurity, gerenciando ciclo de vendas completo até o fechamento. Para isso, é necessário experiência em vendas de soluções de...

  • Manager Commercial Quality Medtech Latam

    3 semanas atrás

    Sao Paulo, Brasil Johnson & Johnson Tempo inteiro

    **We are searching for the best talent for Manager Commercial Quality MedTech LATAM to be in Sao Paulo or San Jose dos Campos or Mexico City or Santiago de Chile or Bogota.** Diversity, Equity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and...

  • Commercial Quality Sr. Manager

    Há 1 mês

    State of São Paulo, Brasil Johnson & Johnson Tempo inteiro

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across...

  • Regional Account Manager

    2 semanas atrás

    São Paulo, Brasil Trend Micro Brasil Tempo inteiro

    Estamos contratando um Regional Account Manager para mercado privado : baseado em São Paulo ( Capital ou Interior). Nesta oportunidade, o Regional

  • Regional Account Manager

    1 semana atrás

    São Paulo, Brasil Trend Micro Brasil Tempo inteiro

    Estamos contratando um Regional Account Manager para mercado privado : baseado em São Paulo ( Capital ou Interior). Nesta oportunidade, o Regional

  • Regional Audit Manager

    1 semana atrás

    Sao Paulo, Brasil World Vision International Tempo inteiro

    With over 70 years of experience, our focus is on helping the most vulnerable children overcome poverty and experience fullness of life. We help children of all backgrounds, even in the most dangerous places, inspired by our Christian faith. Come join our 34,000+ staff working in nearly 100 countries and share the joy of transforming vulnerable children’s...

  • Quality Control Senior Manager

    3 semanas atrás

    Sao Paulo, Brasil PepsiCo Tempo inteiro

    **Responsibilities** PepsiCo products are enjoyed by consumers more than one billion times a day in more than 200 countries and territories around the world. PepsiCo generated more than $79 billion in net revenue in 2021, driven by a complementary beverage and convenient foods portfolio that includes **LAY’S ®, DORITOS ®, CHEETOS ®, GATORADE ®, PEPSI...

  • Quality Control Senior Manager

    3 semanas atrás

    Sao Paulo, Brasil PepsiCo Tempo inteiro

    **Responsibilities**: PepsiCo products are enjoyed by consumers more than one billion times a day in more than 200 countries and territories around the world. PepsiCo generated more than $79 billion in net revenue in 2021, driven by a complementary beverage and convenient foods portfolio that includes **LAY’S ®, DORITOS ®, CHEETOS ®, GATORADE ®, PEPSI...

  • Project Quality Manager

    2 meses atrás

    Sao Paulo, Brasil GE Power Portfolio Tempo inteiro

    **Job Description Summary**: The Project Quality Manager (PQM) is responsible for ensuring that the contractual quality requirements (in terms of inspection notification, execution, documentation collection, management of non-conformance reports etc.) are compliant with the scope of supply. You will drive a Culture of Quality where quality is built-in to...

  • Regional Industry Manager

    Há 3 dias

    Sao Paulo, Brasil IFC Systems Corporation Tempo inteiro

    **Regional Industry Manager - Agribusiness, MAS, LAC** **Job #**: - req26355**Organization**: - IFC**Sector**: - Agribusiness**Grade**: - GH**Term Duration**: - 4 years 0 months**Recruitment Type**: - International Recruitment**Location**: - Sao Paulo,Brazil**Required Language(s)**: - English**Preferred Language(s)**: - Portuguese**Closing...

  • Program Manager

    1 semana atrás

    Sao Paulo, Brasil Quality Digital Tempo inteiro

    O que buscamos? Um profissional com forte capacidade analítica, boa comunicação, capaz de trazer uma compreensão clara do trabalho, prioridades, status atual e planos de ação, além de organização e planejamento de iniciativas complexas. Como será o seu dia a dia: Apoio ao comercial no direcionamento de novos projetos/produtos referente ao seu...

  • Regional Service Manager

    2 meses atrás

    Sao Paulo, Brasil Voith Group Tempo inteiro

    **Sobre o Grupo Voith** O Grupo Voith é uma empresa de tecnologia com atuação global. Com seu amplo portfólio de sistemas, produtos, serviços e aplicações digitais, a Voith estabelece padrões nos mercados de energia, papel, matérias-primas, e transporte e automotivo. Fundada em 1867, a empresa atualmente tem cerca de 21.000 colaboradores, gera €...

  • Quality Assurance Specialist Latam

    2 meses atrás

    Sao Paulo, Brasil Vifor Pharma Tempo inteiro

    -CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency, dialysis and nephrology & rare disease. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead...

  • Regional Finance Manager

    Há 1 mês

    Sao Paulo, Brasil International Flavors & Fragrances Tempo inteiro

    Are you passionate about finance advisory that will enable commercial success? Would you love to work for a global organization that is doing more good for people and the planet? Joining science and creativity, we are an international collective of thinkers who partner with customers to bring scents, tastes, experiences, ingredients and solutions for...

  • Quality Assurance Associate

    1 semana atrás

    Sao Paulo, Brasil Marken Tempo inteiro

    **Title: **Quality Associate II **Department**: Quality Assurance **Site**: Brazil **Reportable to**: QA Manager **Line Management Responsibilities**: - N/A_ **Main Purpose**: The Quality Assurance Associate II (QAA II) is responsible for the oversight and implementation of the Marken Quality Management System (QMS), Marken Standard Operating...

  • Regional Procurement Category Manager

    Há 2 dias

    Sao Paulo, Brasil Kimberly-Clark Tempo inteiro

    **Your Job** You’re not the person who will settle for just any role. Neither are we. Because we’re out to create Better Care for a Better World, and that takes a certain kind of person and teams who care about making a difference. Here, you’ll bring your professional expertise, talent, and drive to building and managing our portfolio of iconic,...