Clinical Supply Chain Specialist
4 weeks ago
About the Role
We are seeking a highly motivated and experienced professional to join our team as a Clinical Supply Chain Specialist. In this role, you will be responsible for ensuring that clinical supplies are stored and distributed in compliance with Fisher Clinical Services approved procedures and policies as well as industry regulations such as cGMP and cGDP.
Key Responsibilities:
- Ensure compliance with internal standards, local and international quality and regulatory guidelines for clinical trials supply chain activities
- Deliver monthly reporting on key performance indicators and provide insights on trends, risks, and mitigation plans
- Provide guidance and advice on regulatory and quality matters to clients, suppliers, and internal associates
- Handle internal and external audits and follow up on resulting observations and opportunities for improvement
- Mentor and develop the Quality team to deliver outstanding results
- Partner and collaborate to find opportunities and solutions related to regulatory and quality matters impacting the business
- Lead management reviews of process performance, product quality, and the Pharmaceutical Quality System, advocating for continual improvement
- Establish effective communication processes to ensure timely reporting of quality issues to the appropriate levels of management
Requirements:
- Bachelor's degree or equivalent experience in life science/medical/pharmacy/quality assurance/regulatory affairs or related field
- 5 years of strong QA and production experience or experience in GMP/QMS settings in quality assurance and regulatory affairs
- Knowledge of IMP process, including handling complex protocols and key clients
- Ability to handle complex problems/projects with independent decision-making and analytical thinking skills
- Flexible, adaptable, and strong customer management skills
- Ability to work independently under pressure and handle multiple tasks
- Strong leadership and influencing skills
- Good organizational, written, and verbal communication skills in English
Lifelancer is a talent hiring platform in Life Sciences, Pharma, and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech, data science, and IT domains.
Please use the below Lifelancer link for job application and quicker response.
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Remote Work: No
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