Carregando descrição…

Senior Manager Quality (GMP) em Pedrouços, Portugal - Jobeax

Senior Manager Quality (GMP) em Pedrouços, Portugal is listed on Jobeax. Browse 30,000+ vacancies available.

Job Purpose

The Senior Manager Quality (GMP) will provide oversight ofMoonLake's manufacturing supply chain to ensure compliance with GMP, MoonLake’s regulatory dossiers and the release schedule; provide advice, support and the necessary oversight to client groups on GMP compliance withinMoonLake and CDMOs; collaborate effectively with rest ofMoonLake's Quality team and consultants, representing Quality on specific project teams.

Become familiar withMoonLake's products, technical agreements, regulatory dossiers and subcontracted manufacturing supply chain

Maintain awareness of international GMP compliance requirements for Investigational Medicinal Products, Biotech API and drug product manufacture including the GCP interface

Become familiar with MoonLake's quality systems (contributing to their maintenance and ongoing improvement)

Ensure GXP compliance of contractors for API manufacture and testing, taking responsibility for QA contact with CMO/CTO on set-up, deviations and change assessment and batch review

Provide advice on GMP to client groups within MoonLake, providing necessary oversight to ensure compliance

Become familiar with MoonLake's drug product manufacture and packed stock release procedures and ensure QPs are made aware of any compliance issues which could impact upon the safety of MoonLake's clinical products

Provide QA support to validation activities at CMOs/CTOs

Undertake other quality assurance duties as required

Your profile

Education: Scientific degree (ideally pharmacy, pharmaceutical sciences, Biology, chemistry or related).

Experience: Demonstrable track record and skills/experience gained in Quality functions in multinational pharmaceutical/biotech environment, specifically in batch review/manufacturing oversight.

Skills/knowledge/behavioural competencies:

Good understanding of biologics drug substance manufacturing process

Some experience in aseptic manufacture of biologic DP and/or combination productsis desirable

Some knowledge of validation requirements within the Bio/Pharma industry

Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.

Credible and confident communicator (written and verbal) at all levels.

Strong analytical and problem-solving ability.

Self-motivated, with the ability to work proactively using own initiative

Audit skills would be an advantage but not essential for this role.

Work Location:

2 days a week in our brand new Porto or Zug offices.

Why us?

An exciting job opportunity awaits you! MoonLake is a dynamic and innovative company pushing the boundaries of possibility, and we are looking for passionate individuals to join our stellar team.

What we offer:

Learning Environment: An opportunity to learn and grow alongside experienced professionals in a supportive and innovative biotech environment.

Impactful Work: Contribute to ground-breaking projects that have the potential to transform global healthcare.

Flexibility and Balance: Work remotely/hybrid, enjoying a healthy work-life balance while making meaningful contributions to our team.

Career Growth: A clear path for career progression, with the chance to take on more responsibilities as you develop your skills.

Our Core Values

We look for potential MoonLakers that embody our three core values that drive our pursuit of excellence:

We do Stellar Science: We aspire to create novel therapies that elevate treatment horizons, with innovative science, and high quality, always.

We go beyond: We aspire to be positively disruptive in our field, and bold in the way we challenge the norms and each other.

We unlock value: We aspire to create long-term value for investors and communities.

Candidatar-se à vaga

Vagas semelhantes

Mais vagas como esta

Adentis Portugal

Senior Cybersecurity Manager

Há 4 dias

Com mais de 9 anos de existência a nível nacional, contamos com mais de 300 colaboradores com o nosso ADN e posicionamo-nos no mercado com 3 ofertas de serviço: - Strategy (Outsourcing, Team as a Service, Tech Academies); - R&D (Estágios, POC, Laboratório Tecnológico); - Nearshore.

Portugal, Lisboa

Circle

Senior Quality Platform Engineer - $120,000 - $130,000 A Year - Remote

Há 2 dias

Remoto

$120k USD - $130k USD / year

Designs, builds, and maintains internal tooling, automation, workflows, and quality infrastructure to empower teams for faster, safer, and more confident releases.

Portugal, Lisboa

Senior QA Engineer: End-to-End Quality & Automation Leader

Há 3 dias

Amadeus is seeking a Senior QA Engineer to drive quality across the software development lifecycle. You will balance manual, exploratory, and automated testing to ensure product reliability, including hardware-integrated solutions, in lab and production-like environments. Lead QA practices, mentor engineers, and collaborate ...

Portugal, Oeiras

Tecnimede Group

Senior Analytical Development Technician (M/F) - Pharmaceutical Development

Há 4 dias

... entire life cycle of the medicinal products for human use with a strong investment in research and development. We are looking to reinforce our team with a Senior Analytical Development Technician. The Senior Analytical Development Technician will provide analytical support to drug product R&D projects guaranteeing that ...

Portugal, Lisboa

Quality Assurance Engineer

Hoje

INSCALE is an impactful IT scaling partner to people and businesses. We unite tech talent with forward thinking organizations, building a powerful partnership that pushes both towards the next level.

Portugal, Lisboa

team.it

Quality Assurance Engineer

Hoje

Híbrido
Presencial

Queremos fazer diferente com o essencial. Apostamos numa estratégia de corporativismo sustentável.

Portugal, Lisboa

KEMET Electronics Corporation

Quality Engineer - Trainee

Há 1 dia

273k

... sense of responsibility; - Fluent in English (spoken and written); - Enjoys working as part of a team; - Dynamic, proactive, and motivated; - Basic knowledgeof quality engineering; - Knowledge of quality tools (preferred); What we offer: - Opportunities for professional growth and development; - Ongoing training; - Opportunities ...

Portugal, Évora

KEMET Electronics Corporation

Quality Engineer - Trainee

Há 1 dia

€1,070 por mês

... sense of responsibility; - Fluent in English (spoken and written); - Enjoys working as part of a team; - Dynamic, proactive, and motivated; - Basic knowledge of quality engineering; - Knowledge of quality tools (preferred); What we offer: - Opportunities for professional growth and development; - Ongoing training; - Opportunities ...

Portugal, Beja

KEMET Electronics Corporation

Quality Engineer - Trainee

Há 1 dia

€1,070 por mês

... sense of responsibility; - Fluent in English (spoken and written); - Enjoys working as part of a team; - Dynamic, proactive, and motivated; - Basic knowledge of quality engineering; - Knowledge of quality tools (preferred); What we offer: - Opportunities for professional growth and development; - Ongoing training; - Opportunities ...

Portugal, Évora

Tech Mahindra

Quality Analyst | German

Há 1 dia

Contrato

141k

... accuracy of the output ● Coordinates and facilitates call calibration / training sessions for vendor QA partners ● Trained and certify new IQA / VQAs ● Publishes quality trends, feedback and improvement / enhancement reports ● Deal tactfully and courteously with clients ● Produce Quality reports and dashboards such as TNI, Pareto ...

Portugal, Oeiras

Tech Mahindra

Quality Analyst | Turkish

Há 2 dias

€9.13 por dia

... accuracy of the output - Coordinates and facilitates call calibration/training sessions for vendor QA partners - Trained and certify new IQA/VQAs - Publishes quality trends, feedback and improvement / enhancement reports - Deal tactfully and courteously with clients - Produce Quality reports and dashboards such as TNI, Pareto ...

Portugal, Lisboa

Tech Mahindra

Quality Analyst | German

Há 3 dias

Contrato

141k

Portugal, Oeiras

Tech Mahindra

Quality Analyst | Swedish

Há 3 dias

€9.13 por dia

... accuracy of the output ● Coordinates and facilitates call calibration/training sessions for vendor QA partners ● Trained and certify new IQA/VQAs ● Publishes quality trends, feedback and improvement / enhancement reports ● Deal tactfully and courteously with clients ● Produce Quality reports and dashboards such as TNI, Pareto ...

Portugal, Lisboa

ALTEN

Quality Assurance Tester

Há 7 dias

€10.9 EUR

QA Tester – Ensure Quality & Innovation with ALTEN! At ALTEN, we drive technological innovation through expertise and collaboration. If you are passionate about quality assurance, testing, and problem-solving, we want you on our team! Key Responsibilities: - Analyze functional requirements and define test cases. - Develop ...

Portugal, Porto

J-18808

Remote Senior Quality Platform Engineer - $120,000 - $130,000 A Year - Remote

Há 3 dias

Remoto

$120k USD - $130k USD / year

Seeking a Senior Quality Platform Engineer to design and maintain internal tooling and quality infrastructure for a global community platform. This role is fully remote and offers competitive compensation.

Portugal, Lisboa

Daymon International

Senior Product Development Manager

Há 1 dia

25k

Product Development Senior Manager – Portugal At Daymon, we grow People, Brands, and Businesses! We are currently looking for a Product Development Senior Business Manager to join our International Development Center, based in Lisbon (Miraflores), Portugal. We are looking for an experienced and visionary leader with an ...

Portugal, Lisboa

Morpheus Talent Solutions

Senior Technical Project Manager

Há 2 dias

Senior Technical Project Manager – Autonomous Systems | Relocation to Abu Dhabi We’re hiring several Senior Technical Project Managers for a government-backed deep-tech organisation in Abu Dhabi, leading complex engineering programmes across autonomous systems, robotics and advanced technology. The role will take ownership ...

Portugal, Lisboa

TripleTen

Senior Meta Ads Manager

Há 2 dias

Remoto
Tempo integral
Contrato

$50k USD / month

... developed in partnership with Nebius AI. Our team is fully remote and globally distributed, and we serve a large, active student base across both regions. As our Senior User Acquisition Manager , you'll own one of our largest paid channels end to end — strategy, budget allocation, creative direction and funnel performance. This ...

Portugal, Lisboa

Application Service Manager - Senior

Há 3 dias

Híbrido

Conhece a askblue ? Nascemos em 2013, e prestamos serviços na área de tecnologias da informação. Estamos à procura de Application Service Manager Senior para se juntar à nossa empresa, num dos nossos projetos. Conhece a askblue ? Nascemos em 2013, e prestamos serviços na área de tecnologias da informação. Estamos à procura ...

Portugal, Lisboa

CTS Group

Senior Business Development Manager

Há 3 dias

Job Location- Porto/Lisbon, Portugal The Senior Business Development Manager serves as one of CTS’s principal technical ambassadors to the European data centre industry. This is not a traditional sales or commercial role. Instead, the position focuses on developing trusted relationships with senior client organisations, ...

Portugal, Porto