Head of Quality & Regulatory

About the role

Cytonome has an immediate opening for an experienced, full-time Head of Quality & Regulatory. This position is in office in Lexington, MA and does not offer relocation assistance. The Head of Quality & Regulatory will possess strong Quality, Regulatory & Safety knowledge, analytical skills, excellent communication skills, a collaborative style, the ability to influence Quality, Regulatory & Safety within and outside the organization and a have a strong customer focus.

Responsibilities

• Drive Quality, Regulatory & Safety strategies for the company
• Build and manage the QARA team
• Responsible for driving Quality, Regulatory & Safety compliance initiatives in a fiscally responsible manor to meet business needs
• 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 the QARA 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, s/w 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
• Is the Quality Management Representative, fulfilling the requirements of ISO
• Working 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.)

Qualifications

• 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 medical device or pharmaceutical industry
• Experience in research & development, preferably medical device or biolab
• Excellent interpersonal and communication skills and sound organizational skills
• Must be able to multi-task and evaluate priorities