Northreach is a dynamic recruitment agency that connects businesses with top talent in the cell & gene therapy, fintech, and digital sectors. Our mission is to provide a seamless and personalised recruitment experience for clients and candidates, and to create a positive work environment that encourages equality, innovation, and professional growth.Position Overview: The QA Manager will be responsible for overseeing and ensuring the quality systems and compliance requirements for our cell and gene therapy products. This role requires an individual with strong technical knowledge of Good Manufacturing Practices (GMP), regulatory standards, and the ability to manage and implement quality systems across production and development stages.The ideal candidate will have a deep understanding of the biotech industry, particularly in cell and gene therapy, and will play an integral role in maintaining quality compliance with both internal and external standards.Key Responsibilities:Quality Management Systems (QMS): Lead the implementation, maintenance, and continuous improvement of the Quality Management System (QMS) in compliance with GMP, GxP, and other relevant regulatory standards (FDA, EMA, etc.).GMP Compliance: Ensure that manufacturing processes, product testing, and facility operations meet GMP requirements, including conducting regular audits and assessments.Regulatory Compliance: Monitor and interpret relevant local, national, and international regulatory guidelines and ensure all activities are compliant with FDA, EMA, ICH, and other regulatory bodies' standards.Deviation & CAPA Management: Lead investigations into deviations, non-conformances, and out-of-specification results. Ensure effective corrective and preventive actions (CAPAs) are identified, documented, and implemented.Documentation & Records Review: Oversee the preparation, review, and approval of key quality documentation, such as batch records, SOPs, validation protocols, and other technical documents.Training & Development: Provide training and mentorship to junior QA staff, ensuring all team members are up-to-date on the latest quality standards, best practices, and regulatory requirements.Risk Management: Support risk assessment and management processes for the product lifecycle and contribute to risk mitigation strategies across the quality system.Audits & Inspections: Coordinate internal and external audits, including those from regulatory bodies and third-party partners, and ensure timely and effective responses to audit findings.Collaboration: Work cross-functionally with other departments, such as Manufacturing, Regulatory Affairs, R&D, and Clinical Operations, to ensure alignment on quality expectations and regulatory compliance.Qualifications & Experience:Education: Bachelor’s degree in Life Sciences, Biotechnology, Pharmaceutical Sciences, or a related field. A Master’s degree or higher is a plus.Experience: Minimum of 5 years of experience in quality assurance within the biotech or pharmaceutical industry, with a focus on cell and gene therapy or biologics.Knowledge: In-depth knowledge of GMP, GxP, FDA/EMA regulations, and other relevant industry standards. Experience with cell and gene therapy processes and regulations is highly preferred.Skills:Strong understanding of quality systems and regulatory compliance in biotech.Proven experience in quality audits, investigations, and CAPA processes.Excellent problem-solving skills and attention to detail.Strong communication, leadership, and organizational skills.Ability to work in a fast-paced and dynamic environment.Proficiency with QMS software and other quality-related tools.Desirable Skills:Experience with cell and gene therapy production processes and quality challenges.Knowledge of regulatory submission processes for biologics and gene therapies.Previous experience with quality control (QC) and analytical testing in biologics.Northreach is an equal opportunity employer and we do not discriminate against any employee or applicant for employment based on race, colour, religion, sex, national origin, disability, or age. We are committed to promoting diversity, equity, and inclusion in the workplace and hiring practices, therefore only partner with business that promote DEI. We strive to create a welcoming and inclusive environment for all employees.