Quality Assurance - Biotechnology CDMO · General

Summary

Review and approve SOPs, conduct and document internal audits, lead investigations for moderate deviations, and provide training and guidance to P1 staff.

This level — P2 P2 — Developing Professional

Early-career professional; developing skills, handles routine tasks with some independence

Who does this work

A Quality Assurance professional in a biotechnology CDMO who seeks to ensure patient safety and product efficacy through rigorous standards and compliance monitoring.

The problem this role solves

Regulatory complexities and ensuring compliance with FDA/EMA standards in the biotechnology industry. The pressure to maintain high-quality standards while managing fast-paced development and manufacturing processes. The belief that every patient deserves safe and effective products, and that quality assurance is critical in fulfilling this responsibility.

The transformation

Achieving full compliance with FDA/EMA regulations with minimal non-conformities. Ensuring product launches are timely with zero recalls due to quality failures. Building a culture of quality that empowers all employees to prioritize safety and efficacy.

What's at risk

Facing regulatory penalties due to lapses in quality assurance processes. Experiencing product recalls that jeopardize patient safety and company reputation. Creating a disjointed approach to quality that leads to inefficiencies and compliance failures.

How the role wins

• Implement comprehensive quality systems into product development activities.
• Monitor operations continuously to ensure adherence to quality standards.
• Conduct regular training sessions for personnel on compliance and best practices.
• Perform audits and inspections to verify compliance with regulatory requirements.
• Collaborate with cross-functional teams to identify and mitigate quality risks.