Director of Quality & Regulatory

About the Company

Cytonome was founded in 2009 on the premise of providing advanced solutions for cell purification needs. By developing cutting-edge technologies in cell purification and platform design, Cytonome provides novel solutions for cell therapy, research, and industry. With deep engineering expertise in the cytometry field and an expansive intellectual property portfolio, Cytonome aims to develop products that simplify existing workflows and enable leading-edge advances and research.

About the Role

This is an in-office, full-time position located in Lexington, MA. Relocation assistance is not offered. The Director of Quality & Regulatory will possess strong Quality, Regulatory, and Safety knowledge, analytical skills, excellent communication skills, a collaborative style, and a strong customer focus. This role involves driving Quality, Regulatory, and Safety strategies, building and managing the QARA team, and ensuring compliance initiatives meet business needs in a fiscally responsible manner.

Responsibilities

• Be the leader of the Quality, Regulatory & Safety function by designing and implementing appropriate Quality, Regulatory & Safety systems and programs.
• Advise the organization on applicable Quality, Regulatory & Safety requirements and standards.
• Manage the QARA function, ensuring team activities are planned, resources allocated, priorities established, and activities executed.
• Ensure the business remains compliant with local, federal, and global Quality, Regulatory & Safety regulations and standards.
• Implement, oversee, and maintain NCMR, CAPA (Corrective and Preventative Actions), complaints, validations, software validations, inspections, document control, supplier quality, and problem resolution processes.
• Conduct Quality and Safety Audits and assure timely corrective actions.
• Handle quality/regulatory/safety compliance inquiries.
• Manage external Auditors and Regulatory Agencies on-site audits and follow-ups.
• Serve as the Quality Management Representative, fulfilling the requirements of ISO.
• Work cross-functionally to assure design & change control systems are effective.
• Establish, maintain, and assure product safety and regulatory filings and compliance enabling timely US and global product registrations and licensing.
• Review & approve product labeling & marketing literature for regulatory compliance.
• Manage product vigilance reporting and responses to Regulatory Agencies.
• Promote quality/regulatory/safety awareness throughout the organization.
• Educate/train company employees on quality/regulatory/safety matters to assure compliance with requirements.
• Managerial responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
• Adhere to applicable laws, regulations, and Company’s policies, procedures, including quality management (ISO-9001, ISO-13485, FDA QSR, GMP, etc.), environmental, safety, and health (OSHA, EPA, DOT, MWRA, etc.).

Requirements

• Bachelor’s Degree in Engineering or Scientific discipline; Master’s degree preferred.
• 10 years of broad experience in Quality Assurance, Regulatory Affairs, Compliance, and Safety.
• 10 years’ experience in progressive leadership and management.
• Experience in the medical device or pharmaceutical industry.
• Experience in research & development, preferably in medical device or biolab.
• Excellent interpersonal and communication skills and sound organizational skills.
• Must be able to multi-task and evaluate priorities.