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Quality Specialist

4 weeks ago

Ottawa, Ontario, Canada MoonLake Immunotherapeutics Full time
Job Purpose

The Quality Specialist supports the Device and GMP Senior Quality Managers in providing Quality oversight of MoonLake's manufacturing supply chain to ensure compliance with GMP, Device manufacturing requirements, MoonLake's regulatory dossiers and the release schedule. Provides necessary oversight to client groups on GMP compliance within MoonLake and CDMOs, with specific emphasis on tracking and review of deviations, changes and manufacturing records. Collaborates effectively with rest of the MoonLake Quality team and consultants to ensure a seamless delivery of support to MoonLake functional groups.

Key Accountabilities

- Become familiar with MoonLake products, technical agreements, regulatory dossiers and subcontracted manufacturing supply chain.
- Maintain awareness of international GMP compliance requirements relevant to MoonLake's Drug-Product-Device combination products.
- Become familiar with MoonLake's quality systems (contributing to their maintenance and ongoing improvement).
- With the Senior Manager GMP Quality, ensure GXP compliance of contractors for Drug Product manufacture and testing, delegating as the QA contact with CMO/CTO on set-up, deviations and change assessment and batch review.
- With the Senior Manager Device Quality, ensure compliance of contractors for manufacture and testing of DP-device combination products, delegating as the QA contact with CMO/CTO on set-up, deviations and change assessment and batch review.
- Become familiar with MoonLake's packed stock oversight and release procedures and ensure QPs are made aware of any compliance issues which could impact upon the safety of MoonLake's clinical products.
- Manage MoonLake's internal review process for any deviations and changes associated with DP or device manufacture.
- Undertake other quality assurance duties as required.

Your Profile

Education:

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

Experience:

- Some experience of working in Quality functions in a pharmaceutical/biotech or Device manufacturing environment, specifically in Batch review/manufacturing oversight.
- Experience gained in other sectors operating similar Quality Systems (e.g. ISO9001) would also be considered.

Skills/Knowledge/Behavioural Competencies:

- A basic understanding of Biologics Drug Product and/or Medical Device compliance requirements is desirable but not an absolute requirement.
- Some experience in Aseptic manufacture of Biologic Drug Products and/or medical devices would be an advantage.
- 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 within a matrix team structure.

Work Location:

- 2 days a week in our brand new Cambridge or Porto Office(s).

Why Us?

An exciting job opportunity awaits
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.

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