Corporate Quality Senior Manager

2 semanas atrás

Lisboa, Lisboa, Portugal Hovione Tempo inteiro
Join a Market LeaderHovione is an independent family owned international group of companies.

From the beginning, we have set ourselves above and apart through our innovative technological and productive capabilities, reaching a top spot in the world market as an integrated Contract Development and Manufacturing Company dedicated to helping Pharmaceutical Customers bring new and off-patent drugs to market.

Our people are the main asset for our continued success.

Reaching over 1950 team members, from 36 different nationalities, that are located across Asia, Europe and North America (Portugal, US, Macao, Ireland, China, Hong Kong, Japan, India, and Switzerland), including 4 production sites.

Working at Hovione means reaching for innovation and excellence in everything we do: for our clients, our partners and, above all, our patients.

That is why we are In it for life.

You will be responsible to:

Implements and manages the required guidelines and cGMPs for Hovione, providing LEAN based Quality Systems and Tools, controlled, harmonized and aligned with the company's strategic plan, promoting a rigorous and continuous improvement culture to guarantee high quality compliant sites.

Maintains active and efficient communication channels along the several Hovione sites, identifying Quality needs and improvements both from internal and external stakeholders.

Evaluates, advises and provides services and technical support, internally and externally, related to the legal and scientific regulatory requirements in relation to product development, commercialization and optimization across the full product lifecycle to ensure compliance with both global and local regulatory legislation, guidelines, inspections, audits and other regulatory due diligence.

Represents Hovione through communications and negotiations with regulatory authorities, preparing, submitting and managing all matters related to regulatory submissions and licensing for Hovione and customer products; and within professional associations, industry/trade groups.


  • Assure the implementation of a Quality system (Project VMP, URSs, SOPs adoption, Q&V, Site Master File, QC)
  • Participate in Conceptual, Basic and Detailed design review of the project in order to assure the GMP Compliance against applicable Guidelines
  • Assure the application of QRM tools and methodologies for new standards
  • Assure regulatory counseling during project implementation
  • Review all documentation and be the quality representative in the discussion with INFARMED GARC and FDA CDER/OPQ
  • Prepare and be the host of regulatory inspections (e.g. INFARMED)
  • Evaluate the area resources needs (material and human) in line with Project strategy, vision and objectives
  • Maintain active and efficient communication channels with Corporate Quality functions, operational areas and with project stakeholders in order to accomplish project goals, with a spirit of collaboration, and mutual help and support
  • Promote the importance of a wellstructured
  • Risk based approach through the applicability of the appropriate tools and methodologies
  • Coordinate the TMs assigned to his/her area of responsibility, namely in terms of recruitment, integration, training needs and performance management in accordance with the company's HR policies, in order to ensure all TMs are aligned and motivated towards achieving Hovione's goals, values and culture by promoting their personal and professional development whilst maximizing productivity.
  • Develop and propose for superior approval the activity plan and related budget for the Area under responsibility in line with the unit's strategy, in order to align activities with DEPARTMENT strategic objectives
  • Monitor Communication ́s budget, by controlling budget evolution, identifying any deviations between the real and the foreseen and taking corrective measures.
  • Ensure compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione ́s policies, systems and procedures (COPs, HBR, SOPs and others) within his/ her TMs.
  • Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
We are looking to recruit a Candidate:
  • Masters' degree in Chemistry, Chemical, Mechanical or Electrical Engineering, or related field
  • Technical background preferred
  • LEAN 6Sigma Green Belt certification preferred
  • Typically requires 10 years of relevant experience, preferably in an operational area such as installation, qualification or maintenance of Facilities and Equipment and/or Quality Assurance;
  • Proven experience in leading others in project context
  • Effective time management skills and the ability to multitask.
  • Track record of overachieving targets
  • Possess extensive knowledge of Facilities and Equipment Qualification & Validation, cGMP and Data Integrity principles and practices and is able to effectively share them with others
  • Understanding of Risk Assessment principles and tools, essentially applied to Qualification & Validation
  • Good communication skills (verbal and written)
  • Skilled at managing complex processes and tools
  • Fluency in English is a requirement
  • Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down.
Hovione is a proud Equal Opportunity Employer Inclusion and diversity are key to us. At Hovione, that means a work environment where differences are valued, and everyone is treated with fairness and respect.

We want all our team members worldwide to feel supported, respected, and have the opportunity to achieve their full potential, regardless of their age, gender, religion, disability, sexual orientation or ethnicity.

#J-18808-Ljbffr

  • Corporate Quality Senior Manager

    2 semanas atrás

    Lisboa, Lisboa, Portugal Hovione Tempo inteiro

    Corporate Quality Senior ManagerLisboa Lisbon, Lisbon, Portugal Join a Market Leader Hovione is an independent family owned international group of companies. From the beginning, we have set ourselves above and apart through our innovative technological and productive capabilities, reaching a top spot in the world market as an integrated Contract Development...

  • Data Quality Enablement Senior Manager

    2 semanas atrás

    Lisboa, Lisboa, Portugal The Boston Consulting Group GmbH Tempo inteiro

    WHAT YOU'LL DO The Data Quality Enablement Senior Manager plays a critical role ensuring that the data used within the organization is accurate, complete, and reliable by promoting and facilitating high standards of data quality. We are seeking a Data Quality Enablement Senior Manager with a visionary outlook towards integrating Data Governance and Quality...

  • Data Quality Enablement Senior Manager

    2 semanas atrás

    Lisboa, Lisboa, Portugal Boston Consulting Group Tempo inteiro

    Data Quality Enablement Senior Manager Lisboa Data Quality Enablement Senior ManagerLisboa Lisboa, Lisboa, Portugal WHAT YOU'LL DO Data Quality Enablement Senior ManagerLisboa Lisboa, Lisboa, Portugal WHAT YOU'LL DO The Data Quality Enablement Senior Manager plays a critical role ensuring that the data used within the organization is accurate, complete, and...

  • Data Quality Enablement Senior Manager

    2 semanas atrás

    Lisboa, Lisboa, Portugal Boston Consulting Group Tempo inteiro

    Data Quality Enablement Senior Manager Lisboa Data Quality Enablement Senior ManagerLisboa Lisboa, Lisboa, Portugal WHAT YOU'LL DO Data Quality Enablement Senior ManagerLisboa Lisboa, Lisboa, Portugal WHAT YOU'LL DO The Data Quality Enablement Senior Manager plays a critical role ensuring that the data used within the organization is accurate, complete, and...

  • Senior Test Manager

    2 semanas atrás

    Lisboa, Lisboa, Portugal Hover Senior Living Community Tempo inteiro

    We are seeking a Senior Test Manager to join our team and take charge of designing a comprehensive test process from scratch while driving the adoption of testing practices across the organization. As a Senior Test Manager, you will play a pivotal role in ensuring the quality and reliability of our products and services by establishing robust testing...

  • Corporate Performance Management Senior Associate

    2 semanas atrás

    Lisboa, Lisboa, Portugal Verisure Sàrl Tempo inteiro

    Corporate Performance Management Senior Associate Lisboa Verisure is seeking an experienced, talented, innovative,- on and passionate Corporate Performance Management Senior Associate to support our Group Corporate Performance Management Team, with colleagues in Sweden, Madrid and Lisbon. The role will report to the Group Corporate Performance Management...

  • Corporate Internal Audit Manager

    2 semanas atrás

    Lisboa, Lisboa, Portugal Jerónimo Martins Tempo inteiro

    YOUR MISSION IN OUR INTERNAL AUDIT TEAMWe are looking for a Corporate Internal Audit Manager to integrate the Internal Audit department. The Manager will carry out audit assignments on the different Companies of the Group, including the definition of audit programs and helping the Group to accomplish its objectives by bringing a systematic, disciplined and...

  • Quality Manager

    2 semanas atrás

    Lisboa, Lisboa, Portugal Intelcia Tempo inteiro

    Quality Manager LisbonLisboa Lisbon, Lisbon, Portugal As a global outsourcing company, we take care of processes and functions to help our clients to stay focused on their objectives and core missions. We are currently looking for a Quality Manager to join our team in Lisbon.Your mission: Responsible for the ISO quality certification in Portugal, liaising...

  • Senior Project Manager – Corporate And Investment Banking

    2 semanas atrás

    Lisboa, Lisboa, Portugal ITDSPortugal Todos Tempo inteiro

    Senior Project Manager – Corporate and Investment Banking Unleash your potential in a role where big data and technology innovation intersect This is a hybrid Lisbon-based opportunity – 2x in the office As a Senior Project Manager for our client, you'll be at the forefront of data solutions, crafting applications on cutting-edge platforms. You will be...

  • Corporate Sustainability Senior Consultant

    2 semanas atrás

    Lisboa, Lisboa, Portugal Tn Portugal Tempo inteiro

    Corporate Sustainability Senior Consultant Lisboa Corporate Sustainability Senior Consultant Lisboa Lisboa, Lisboa, Portugal col-wideJob Description:ERM Portugal is hiring Following an exciting period of continuous growth and development of projects in ERM Portugal, we are seeking aSenior Consultantwith expertise inthe area ofCorporate Sustainability and...

  • Corporate Quality Senior Manager

    2 semanas atrás

    Lisboa, Lisboa, Portugal Hovione Tempo inteiro

    Join a Market Leader:Hovione is an independent family owned international group of companies. From the beginning, we have set ourselves above and apart through our innovative technological and productive capabilities, reaching a top spot in the world market as an integrated Contract Development and Manufacturing Company dedicated to helping Pharmaceutical...

  • Corporate Quality Senior Manager

    2 semanas atrás

    Lisboa, Lisboa, Portugal Hovione Tempo inteiro

    Join a Market Leader Hovione is an independent family owned international group of companies. From the beginning, we have set ourselves above and apart through our innovative technological and productive capabilities, reaching a top spot in the world market as an integrated Contract Development and Manufacturing Company dedicated to helping...

  • Data Quality Enablement Senior Manager

    2 semanas atrás

    Lisboa, Lisboa, Portugal The Boston Consulting Group Gmbh Tempo inteiro

    WHAT YOU'LL DOThe Data Quality Enablement Senior Manager plays a critical role ensuring that the data used within the organization is accurate, complete, and reliable by promoting and facilitating high standards of data quality. We are seeking a Data Quality Enablement Senior Manager with a visionary outlook towards integrating Data Governance and Quality at...

  • Senior Project Manager – Corporate And Investment Banking

    2 semanas atrás

    Lisboa, Lisboa, Portugal Itdsportugal Todos Tempo inteiro

    Senior Project Manager – Corporate and Investment BankingUnleash your potential in a role where big data and technology innovation intersectThis is a hybrid Lisbon-based opportunity – 2x in the officeAs a Senior Project Manager for our client, you'll be at the forefront of data solutions, crafting applications on cutting-edge platforms. You will be...

  • Data Quality Enablement Senior Manager

    2 semanas atrás

    Lisboa, Lisboa, Portugal Boston Consulting Group Tempo inteiro

    WHAT YOU'LL DO:The Data Quality Enablement Senior Manager plays a critical role ensuring that the data used within the organization is accurate, complete, and reliable by promoting and facilitating high standards of data quality.We are seeking a Data Quality Enablement Senior Manager with a visionary outlook towards integrating Data Governance and Quality at...

  • Senior Project Manager – Corporate And Investment Banking

    2 semanas atrás

    Lisboa, Lisboa, Portugal Itdsportugal Todos Tempo inteiro

    Senior Project Manager – Corporate and Investment BankingUnleash your potential in a role where big data and technology innovation intersectThis is a hybrid Lisbon-based opportunity – 2x in the officeAs a Senior Project Manager for our client, you'll be at the forefront of data solutions, crafting applications on cutting-edge platforms. You will be...

  • Senior Quality Manager

    2 semanas atrás

    Lisboa, Lisboa, Portugal Claire Joster Tempo inteiro

    Our client is a company specialized in the construction of large industrial projects. Currently, they are strengthening their team by looking for an Senior Quality Manager (M/F) to support their global projects.Key Responsibilities: Support the QSE Director within the scope of the objectives defined for the QSE Depart; As required, provide quality support to...

  • Senior Project Manager – Corporate And Investment Banking

    2 semanas atrás

    Lisboa, Lisboa, Portugal Itdsportugal Todos Tempo inteiro

    Senior Project Manager – Corporate and Investment BankingUnleash your potential in a role where big data and technology innovation intersectThis is a hybrid Lisbon-based opportunity – 2x in the officeAs a Senior Project Manager for our client, you'll be at the forefront of data solutions, crafting applications on cutting-edge platforms. You will be...

  • Quality Manager

    2 semanas atrás

    Lisboa, Lisboa, Portugal Intelcia Tempo inteiro

    Quality Manager LisbonLisboa Lisbon, Lisbon, Portugal As a global outsourcing company, we take care of processes and functions to help our clients to stay focused on their objectives and core missions. We are currently looking for a Quality Manager to join our team in Lisbon.Your mission: Responsible for the ISO quality certification in Portugal, liaising...

  • Quality Manager

    2 semanas atrás

    Lisboa, Lisboa, Portugal Intelcia Tempo inteiro

    Quality Manager LisbonLisboaLisbon, Lisbon, Portugal As a global outsourcing company, we take care of processes and functions to help our clients to stay focused on their objectives and core missions.We are currently looking for a Quality Manager to join our team in Lisbon.Your mission:Responsible for the ISO quality certification in Portugal, liaising with...