We are seeking a highly motivated and experienced Director/Sr. Director of Quality to lead our quality function. The successful candidate will be responsible for ensuring compliance with quality standards, overseeing all aspects of quality control, and leading continuous improvement efforts across the organization. The candidate must have experience with both CMC (Chemistry, Manufacturing, and Controls) and QMS (Quality Management Systems) in a biotechnology or pharmaceutical setting. Experiences with GCP and GLP are also desired.

KEY RESPONSIBILITIES

• Develop, implement, and maintain a comprehensive, phase appropriate quality system, including policies, procedures, maintain regulatory status, and guidelines in compliance with relevant regulatory requirements, such as FDA, EMA, ICH.
• Oversee all aspects of the quality function, quality assurance, and quality systems, to ensure that all products and processes are consistent with established quality standards.
• Provide Quality oversight of all GMP CMC activities (e.g., review/approval of batch records, specifications, batch disposition, stability protocols, etc.)
• Develop fit-for-purpose internal SOPs, work instructions, and other processes to ensure appropriate employee training and adherence to quality management system (QMS) across the GxPs;
• Ensure training documentation are current, relevant and appropriately maintained.
• Ensure the qualification, selection and management of vendors and contractors through defined qualified processes.
• Create a process for identifying, adjudicating and remediating risks and/or compliance concerns/issues. Ensure rapid escalation of significant quality issues or concerns
• Manage the Corrective and Preventive Action (CAPA) program to identify and address quality issues, root cause analysis, and preventive measures.
• Provide strategic direction and leadership to the quality team, including hiring, training, and mentoring staff members.
• Develop and implement quality metrics to monitor and track performance, identify trends, and drive continuous improvement.
• Conduct internal audits and manage/conduct external audits to ensure compliance with regional specific regulations and standards.
• Collaborate with cross-functional teams, including Manufacturing, Regulatory Affairs, Clinical and R&D, to ensure quality compliance throughout the product development life cycle.

PROFESSIONAL EXPERIENCE/QUALIFICATIONS

• Degrees in Bachelor or Master in a scientific discipline (e.g., Chemistry, Biology, Biochemistry) or related life-science discipline.
• At least 10 years of experience in quality assurance, quality control, and/or quality systems in a biotechnology or pharmaceutical setting.
• Strong knowledge of CMC and QMS requirements and experience in implementing them. GCP and GLP Quality experience not required, preferred.
• Proven leadership skills with the ability to build and motivate a high-performing team.
• Excellent communication and interpersonal skills to establish effective relationships with internal and external stakeholders.
• Demonstrated experience in managing internal and external audits and interacting with regulatory agencies.
• Strong problem-solving skills with the ability to identify issues, develop solutions, and implement corrective and preventive actions.
• Ability to work in a fast-paced, dynamic environment and manage multiple priorities and deadlines.
• Strong computer skills, including experience with electronic quality management systems.
• Regulatory experience in drug development, including IND/CTA, NDA, BLA/MAA filings and health authority inspections.