BioInnovate Solutions, a leading biotechnology company specializing in novel gene therapies and personalized medicine, is seeking an experienced and proactive Quality Assurance Manager to lead our QA team.

About the Role

As our Quality Assurance Manager, you will play a pivotal role in ensuring the highest standards of quality and compliance across our innovative product portfolio. You’ll be responsible for developing and implementing quality management systems, policies, and procedures to meet regulatory requirements and industry best practices.

Key Responsibilities

• Develop and maintain quality management systems (QMS) in accordance with ISO standards and regulatory requirements
• Establish and enforce quality assurance policies, procedures, and standards to ensure consistency and compliance across all operations
• Conduct internal audits and assessments to evaluate the effectiveness of quality systems and identify areas for improvement
• Lead investigations into quality issues, non-conformances, and customer complaints, implementing corrective and preventive actions (CAPAs)
• Provide guidance and support to cross-functional teams on quality-related matters, including product development, manufacturing, and regulatory affairs
• Oversee a team of QA professionals, providing leadership, mentorship, and training

Qualifications

• Bachelor’s or Master’s degree in quality management, life sciences, engineering, or a related field
• Proven experience in quality assurance management within the biotechnology or pharmaceutical industry
• In-depth knowledge of quality management principles, regulations, and standards, such as ISO 9001, ISO 13485, and cGMP
• Strong leadership and interpersonal skills, with the ability to effectively communicate and collaborate with stakeholders at all levels
• Excellent problem-solving abilities, analytical skills, and attention to detail

Darwin Recruitment is acting as an Employment Agency in relation to this vacancy.

Ryan Griffin