Quality Assurance Manager
4 days ago
We are seeking a highly skilled and experienced Quality Assurance Manager to join our team at Forge Biologics. As a key member of our Quality Assurance team, you will be responsible for ensuring the quality and compliance of our gene therapy manufacturing operations.
Key Responsibilities- Develop and implement quality policies and procedures to ensure compliance with regulatory requirements.
- Provide expert guidance and support to the Quality Assurance team to ensure the quality and integrity of our products.
- Collaborate with cross-functional teams to resolve quality issues and implement corrective actions.
- Develop and maintain quality documentation, including SOPs, work instructions, and batch records.
- Lead audits and inspections to ensure compliance with regulatory requirements.
- Develop and implement training programs to ensure quality awareness and compliance among team members.
- Bachelor's degree in a scientific-related field or engineering.
- Minimum 5 years of experience in a Quality Assurance role in a GxP regulated industry.
- Proven experience in providing QA oversight for cGMP manufacturing operations.
- Knowledge of drug development regulations, including GCPs, GMPs, and GLPs.
- Experience in supporting regulatory audits and inspections.
- Strong technical aptitude and problem-solving skills.
- Excellent communication and interpersonal skills.
- A competitive salary and benefits package.
- Opportunities for professional growth and development.
- A dynamic and collaborative work environment.
- Recognition and rewards for outstanding performance.
We are an equal opportunity employer and welcome applications from diverse candidates. If you are a motivated and experienced Quality Assurance professional looking for a new challenge, please submit your application.
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