Senior Manager Quality (GMP)

Moonlake; Schweiz; Hybrid; CHF 150.000 - 190.000; Vollzeit

Benefits dieser Stelle

Learning Environment

Impactful Work

Remote/Hybrid flexibility

Career Growth

Zusammenfassung

MoonLake is seeking a Senior Manager Quality (GMP) to oversee the manufacturing supply chain and assure compliance with GMP and MoonLake's regulatory dossiers. You will guide QA with CMOs/CTOs and support project teams across the global biosciences landscape.

Based in a hybrid setting with two days on our Porto or Zug sites, you will drive quality systems, batch release oversight, validation support, and continuous improvement, while maintaining high standards of precision and collaboration.

Qualifikationen

• Scientific degree in pharmacy, pharmaceutical sciences, biology, chemistry, or related field.
• Demonstrable track record in quality functions in multinational pharma/biotech.
• Experience with batch review and manufacturing oversight.

Aufgaben

• Familiarize with MoonLake products, regulatory dossiers, and subcontracted supply chain.
• Maintain awareness of GMP for Investigational Medicinal Products and Biotech API.
• Ensure GXP compliance of contractors for API manufacture and testing; QA contact with CMO/CTO on setup, deviations and batch review.
• Provide GMP advice to MoonLake client groups and oversee compliance.
• Familiarize with drug product manufacture and release procedures; ensure QPs are aware of compliance issues affecting safety of clinical products.
• Provide QA support to validation activities at CMOs/CTOs.
• Undertake other quality assurance duties as required.

Kenntnisse

Biologics manufacturing

Aseptic manufacturing

Validation knowledge

Attention to detail

Effective communicator

Analytical skills

Proactive work

Audit experience

Ausbildung

Scientific degree

Jobbeschreibung

Job Purpose

The Senior Manager Quality (GMP) will provide oversight of MoonLake's manufacturing supply chain to ensure compliance with GMP, MoonLake’s regulatory dossiers and the release schedule; p rovide advice, support and the necessary oversight to client groups on G M P compliance within MoonLake and CDMOs; c ollaborate effectively with rest of MoonLake's Quality team and consultants, representing Quality on specific project teams.

Key Accountabilities

• Become familiar with MoonLake's products, technical agreements, regulatory dossiers and subcontracted manufacturing supply chain
• Maintain awareness of international GMP compliance requirements for Investigational Medicinal P roducts , 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 group s 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 manufac ture of biologic DP and/or combination products is 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 communi cat or (written and verbal) at all levels.
• Strong analytical and problem-solving ability.
• Self-motivated, with the ability to work proactively using own initi a tive
• Audit skills would be an advantage but not essential for this role .

Job Purpose

The Senior Manager Quality (GMP) will provide oversight of MoonLake's manufacturing supply chain to ensure compliance with GMP, MoonLake’s regulatory dossiers and the release schedule; p rovide advice, support and the necessary oversight to client groups on G M P compliance within MoonLake and CDMOs; c ollaborate effectively with rest of MoonLake's Quality team and consultants, representing Quality on specific project teams.

Key Accountabilities

• Become familiar with MoonLake's products, technical agreements, regulatory dossiers and subcontracted manufacturing supply chain
• Maintain awareness of international GMP compliance requirements for Investigational Medicinal P roducts , 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 group s 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 manufac ture of biologic DP and/or combination products is 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 communi cat or (written and verbal) at all levels.
• Strong analytical and problem-solving ability.
• Self-motivated, with the ability to work proactively using own initi a tive
• 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 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.