About the Role
To support a growing portfolio of pharmaceutical projects and upcoming product launches, we are reinforcing our Pharma MSAT Quality team with an experienced MSAT Quality Lead.
You Will Collaborate Closely With
* Internal & External Manufacturing
* CML Development Sciences
* Industrialization & Network Planning
* Global Quality and other business stakeholders
Key Responsibilities
On a typical day, you will be involved in a mix of project and transversal quality activities, including:
* Technology Transfer & Validation
o Support technology transfers (process and/or analytical) for Drug Substance (DS), Drug Product (DP), and Packaging.
o Ensure quality oversight during process validation and continuous process verification (CPV).
* Quality Troubleshooting & Expertise
o Act as second-line support for complex or cross-site quality issues.
o Provide QA expertise during complex investigations and in the definition and follow-up of CAPAs.
o Challenge and review technical content from an operational QA perspective.
* Project & Stakeholder Management
o Participate in cross-functional meetings, ensuring alignment on timelines, risks, and deliverables.
o Maintain close follow-up on project milestones and proactively escalate issues when needed.
* Transversal / Peak-Load Support
o Contribute to quality agreement preparation and review.
o Support vendor-related QA activities.
o Temporarily support other quality teams facing high workload.
Profile & Experience
* Experience:
o Minimum ~5 years of relevant experience in a similar role.
o Strong background in pharmaceutical quality and operations is strongly preferred.
* Seniority:
o Able to operate autonomously, take part in complex technical and quality discussions, and act with limited supervision.
Must-Have Skills & Competencies
* Strong quality mindset with a solid understanding of pharmaceutical regulations (GMP and related guidelines).
* Proven experience in technology transfer (process and/or analytical), ideally in a QA context.
* Operational QA experience with the ability to understand, challenge, and defend technical content.
* Hands-on experience with complex investigations, deviation management, and CAPA lifecycle.
* Excellent communication skills in English (written and verbal).
* Ability to work independently in a cross-functional, international, and multicultural environment.
Nice-to-Have
* Experience in both process and analytical domains.
* Exposure to different formulations and stages: DS, DP, and packaging.
* French language skills.
* Experience in biologics and/or non-pharma industries, provided the quality and tech transfer mindset is strong.
* Previous experience working in global or multicultural teams.
Amaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.
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