Regulatory Compliance Professional
Vor 2 Tagen
About the Job:
Regulatory Compliance ProfessionalWe are seeking an experienced Regulatory Compliance Professional to join our team. As a key member of our quality assurance department, you will be responsible for supervising compliance and customer Quality Agreement activities for drug production.
This role requires close collaboration with Drug Product Services (DPS) teams in Basel/Stein sites (e.g., Slough/Visp) to establish and negotiate Quality Agreements.
Responsibilities:
Regulatory Compliance Professional Responsibilities- Supervise compliance and customer Quality Agreement activities for drug production.
- Collaborate with DPS teams to establish and maintain Quality Agreements.
- Represent Quality Assurance in cross-functional teams and maintain interfaces with Manufacturing, QC, Support Functions, Project and Site Engineering.
- Support continuous improvement programs to enhance the Quality Management System for Drug Product.
Requirements:
Regulatory Compliance Professional Requirements- Bachelor's or Master's degree in Life Sciences, Pharmacy, or a related field.
- 5-10 years of relevant experience in Quality Assurance within drug production or pharmaceutical manufacturing.
- Strong knowledge of GMP regulations and compliance requirements.
- Experience in negotiating and managing Quality Agreements with external partners.
- Ability to assess and resolve quality-related issues, including deviations, complaints, and investigations.
- Proven ability to work cross-functionally with Manufacturing, QC, Engineering, and Regulatory teams.
- Excellent communication and stakeholder management skills.
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