What are the responsibilities and job description for the Regulatory Compliance Officer position at Minaris?
Join Our Team:
We are a leading global contract development and manufacturing organization dedicated to advancing cell and gene therapy products. As a key member of our quality assurance team, you will play a critical role in ensuring the highest standards of quality and compliance.
Key Responsibilities:
- Develop and implement effective quality control procedures.
- Lead a team of technicians to perform environmental monitoring and microbiological testing.
- Conduct regular audits and inspections to identify areas for improvement.
- Collaborate with cross-functional teams to resolve quality-related issues.
- Stay up-to-date with relevant regulations and industry standards.
Qualifications:
- Bachelor's degree in Microbiology or a related field.
- Minimum 7 years of experience in a quality assurance role.
- Proven track record of leadership and team management.
- Strong knowledge of FDA and EU regulatory standards.
- Excellent communication and interpersonal skills.