My client is seeking a dynamic and hands-on Director of Quality Assurance (QA) to lead and manage our QA activities. As a key member of our small, agile team, you will be responsible for ensuring the highest quality standards are met across all clinical and operational aspects of our biotech programs. This role is crucial for maintaining compliance with regulatory requirements, driving continuous improvement, and supporting the development of novel therapies.
Key Responsibilities:
- Develop, implement, and maintain an effective Quality Management System that aligns with regulatory standards (FDA, EMA, ICH, etc.).
- Ensure that all processes comply with GxP requirements (GMP, GCP, GLP).
- Oversee the management of SOPs, ensuring they are current, effective, and properly implemented.
- Ensure compliance with all applicable regulatory requirements for clinical-stage biotech products.
- Lead preparation and management of regulatory inspections and audits.
- Act as the primary point of contact with regulatory agencies for QA matters.
- Provide QA oversight for all clinical trials, including the review and approval of study protocols, clinical trial agreements, and informed consent documents.
- Monitor and audit clinical trial sites, CROs, and other vendors to ensure compliance with study protocols and regulatory requirements.
- Investigate and resolve any quality issues or deviations in clinical trials.
- Collaborate closely with R&D, manufacturing, and clinical teams to ensure quality is integrated into the development process.
- Provide QA support for CMC (Chemistry, Manufacturing, and Controls) activities, including batch record review and release, stability testing, and validation.
- Lead and mentor a small QA team, fostering a culture of quality and continuous improvement.
- Hands-on management of day-to-day QA activities, including document control, internal audits, and quality issue investigations.
- Develop and implement training programs to ensure all staff are aware of and comply with quality standards.
- Identify and implement opportunities for process improvements to enhance quality and efficiency.
- Stay current with industry best practices and regulatory changes, incorporating them into the QA processes as appropriate.
Experience::
- Bachelor’s degree in Life Sciences, Biotechnology, or a related field. Advanced degree preferred.
- Minimum of 8-10 years of experience in Quality Assurance within the biotech or pharmaceutical industry, with a focus on clinical-stage products.
- Demonstrated experience with GxP compliance, particularly in GMP, GCP, and GLP environments.
- Proven track record of leading regulatory inspections and audits.
- Hands-on experience with QMS implementation and management in a small to mid-sized organization.
Why Join my client?
- Be part of a pioneering biotech company dedicated to developing cutting-edge therapies.
- Work in a collaborative and fast-paced environment with the opportunity to make a significant impact on the company’s success.
- Competitive compensation package, including benefits and opportunities for professional growth.
