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Regulatory Compliance Specialist for Biologics
2 weeks ago
Key Responsibilities:
">The Regulatory Compliance Specialist for Biologics will be responsible for ensuring that all biologic products manufactured at our facility meet the required regulatory standards.
Main Responsibilities:
">- Develop, implement, and maintain QA oversight activities to meet all cGMP regulatory requirements for phase-appropriate clinical and commercial bulk drug substance and drug product manufacture.
- Maintain an operational tier structure to ensure the site is continuously complying with standard operating procedures, processes, regulatory requirements, and partner commitments.
- Lead the Quality Operations team to deliver exceptional performance of each assigned area.
- Perform QA review and approval of deviations, CAPAs, and change controls.
- Identify and implement best practices to improve right first time (RFT) execution.
- Liaise with internal and external stakeholders to achieve expected business outcomes.
- Partner with Quality Compliance to ensure the site is always inspection ready.
About Us:
">We are committed to maintaining the highest level of quality in everything we do, from research and development to manufacturing and delivery.
Requirements:
">- Bachelor's degree with 8 years of relevant experience in a regulated pharmaceutical, biotechnology, or supporting a CDMO environment; OR
- Associate's degree with 10 years of relevant experience in a regulated pharmaceutical, biotechnology, or supporting a CDMO environment.
- At least 4 years of experience in a supervisory or managerial role.
- A minimum of 5 years of experience working with biologics (vaccines, gene therapy, mAb, etc.) in a QA or QC role.
