Site Conformance Expert | Life Sciences

Job Description

As a Site Conformance Expert within our Quality Assurance team, you will be the vital link between operations and regulatory affairs, ensuring compliance across multiple production streams including Primary, Secondary, Quality Control, and Incoming Materials.

In this role you will play a key role in:

• Ensuring compliance to regulatory dossiers for activities related to Manufacturing Performance Units and Quality Control Department through variations and responses to health authority questions.
• Providing regulatory oversight within Manufacturing Performance Units and Quality Control Department to maintain alignment with regulatory requirements.
• Analysing potential compliance gaps and developing mitigation strategies to prevent supply issues, delays, or recalls due to misalignment with regulatory files.
• Collaborating with cross-functional teams to implement and maintain quality systems that meet global regulatory standards.
• Supporting continuous improvement initiatives to enhance compliance processes and documentation systems.

Your profile

• Master's degree in Pharmaceutical Sciences, Chemistry, Biology, or related field.
• Minimum 3 years of experience in a quality assurance role within the pharmaceutical or life sciences industry.
• Strong knowledge of GMP regulations, quality systems, and regulatory compliance requirements.
• Fluent in English and French.
• Experience with regulatory documentation, including eCTD format and normative documents.
• Strong communication skills with the ability to effectively interact with various stakeholders across different departments.

What you'll love about working here

• Hybrid working: We encourage flexibility when it comes to when and where work gets done. You'll work with your manager to determine an arrangement that works best for your role, with at least two days on site to connect with the team.
• Continuous feedback: We take a human-centric approach to foster growth and performance. Our performance management tool GetSuccess enables continuous feedback, quarterly check-ins with managers, and ongoing performance discussions.
• Career acceleration programs: From associate to leaders and beyond, get support in your career at every stage with award-winning programs such as our leadership development program, Connected Manager, to accelerate your growth and develop your expertise.