Development Quality Operations Partner
il y a 3 jours
We are seeking a skilled Development Quality Operations Partner to join our team at Jefferson Wells Belgium.
About the Role:
- As a key member of our Development Quality Pharma Operational team, you will ensure the establishment, implementation, maintenance, and continuous improvement of an effective Quality Management System (QMS) linked to product development.
- You will oversee the GMP oversight of different laboratories and production pilots, including packaging, and outsourcing.
- You will also drive continuous quality improvement processes, ensuring that the QMS in support of product development and clinical supplies meets regulatory requirements and expectations.
- Additionally, you will provide support to build the end-to-end 'issued copy process' for DEV/DSC entities, act as Reconciler, and coordinate the development of local instructions.
- You will contribute to preparing audits (internal/external, regulatory inspections), provide guidance and expert advice to development scientists, and identify, mitigate, and resolve compliance and quality issues.
- You will maintain and continuously improve Quality systems and processes in place for the appropriate documentation of company development activities and ensure compliance with regulatory and corporate requirements.
- Masters or Bachelors degree in a relevant field (e.g., Life Sciences, Engineering, or Quality Management).
- Minimum of 3 years of experience in data integrity and documentation control within the biopharmaceutical industry.
- Good understanding of current regulatory requirements and expectations, ability to interpret current regulations and requirements in the product development context.
- QA/compliance experience in DS/DP/IMP manufacturing, facility operation, laboratory compliance, and quality systems is an asset.
- Fluency in French and English.
- Ability to act independently, handle complex/difficult situations, and impact activities across several departments.
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