Senior Manager Quality (GMP)

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 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.