Corporate Quality Senior Manager

Lisboa
Permanente
Horário completo

Há 2 dias

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 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::Hovione is a global CDMO dedicated to helping pharmaceutical clients bring innovative therapies to market. We are now hiring a Senior Quality Manager to join our Lisbon-based team. This role is a strategic leadership position with oversight of quality systems, compliance, and regulatory readiness for our manufacturing operations, with a focus on API, raw materials, and drug product environments.We are seeking an experienced professional from the pharmaceutical industry, ideally with exposure to CDMO operations and regulatory bodies such as INFARMED and the FDA. The ideal candidate has a strong technical background, extensive knowledge of Qualification & Validation, and a proven ability to lead and motivate cross-functional teams in a dynamic, regulated setting.Key ResponsibilitiesLead implementation and maintenance of GMP-compliant quality systems (e.g., VMPs, SOPs, Q&V, Site Master File, QC).Oversee and support the full design lifecycle to ensure compliance with global GMP standards.Serve as the primary Quality lead for regulatory inspections and audits (INFARMED, FDA), ensuring readiness and response.Apply Quality Risk Management tools and methodologies to maintain proactive compliance.Represent Hovione in regulatory interactions and ensure alignment with evolving scientific and legal standards.Review all relevant project documentation and ensure regulatory expectations are met or exceeded.Coordinate quality resources and ensure optimal team performance in line with project goals.Drive internal communication and collaboration across departments and with Corporate Quality.Promote a risk-based, continuous improvement culture supported by LEAN quality systems.Mentor and lead the Quality team, overseeing performance, development, and recruitment within your scope. We are looking to recruit a Candidate::Master’s degree in Chemistry, Chemical, Mechanical, or Electrical Engineering, or a related field.Strong technical background; extensive experience in Quality Assurance or facilities/equipment qualification is preferred.Typically requires 10 years of relevant experience in pharmaceutical operations or quality roles.Proven leadership in managing teams and complex quality/compliance projects.Deep knowledge of GMP, Data Integrity, and Qualification & Validation standards.Skilled in time management, communication, and stakeholder engagement in regulated environments.Fluency in English required; LEAN Six Sigma Green Belt certification is a plusHovione is a proud Equal Opportunity EmployerInclusion 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.Notice to Agencies and Search Firms Representatives
Hovione does not accept unsolicited résumes from agencies or search firms for this job posting. Any resumes submitted to Hovione by a third-party agency or search firm without a valid written and signed search agreement will become the sole property of Hovione. No fees will be paid if a candidate is hired for this position as a result of an unsolicited referral. Thank you for your understanding.

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