Tiger BioSciences LLC
Overview
Director of Quality Systems
role at
Tiger BioSciences LLC
seeks a leader to oversee the quality management system, including design control, design verification/validation, design history files, and risk assessment to ensure compliance with SOPs, FDA regulations, AATB Standards, ISO standards, and other applicable regulations and industry standards. This role drives quality engineering best practices and collaborates cross-functionally across the organization.
Responsibilities
Develop, implement, and maintain standardized processes in the Quality Management System to ensure compliance with relevant standards and regulations.
Oversee management, review, and approval of quality event investigations from initiation to closure for complaints, deviations, non-conformances, CAPAs, and SCARs; ensure timely completion, appropriate root cause analysis, and effective corrective/preventive actions.
Oversee, lead, and manage quality system related meetings, including management review.
Lead and/or support risk management initiatives by identifying, addressing, and escalating risks/issues as necessary.
Lead and support continuous improvement initiatives to enhance quality system processes.
Oversee and manage use of quality system software.
Lead and provide organizational training and guidance on quality standards, processes, procedures, and corrective/preventive actions.
Oversee management and coordination of training requirements/assignments.
Manage the quality data collection and reporting processes, including tracking and analyzing key performance indicators (KPIs).
Oversee supplier management program to ensure appropriate qualification and maintenance of the approved supplier list.
Support documentation requests from regulatory affairs to support regulatory submissions (e.g., PMA supplements, 510(k) submissions).
Manage internal audit program and schedule to assess and maintain compliance of the quality management system with regulations/standards, and internal policies and procedures.
Direct and lead internal, client, and regulatory agency audits to ensure compliance with regulatory requirements, accreditation/certification requirements, and internal policies and SOPs.
Develop and maintain professional working relationships with current and potential customers, consultants, suppliers, and vendors.
Establish and execute continuing education strategy for the department.
Promote shared leadership and foster collaboration across multi-disciplinary teams.
Maintain company compliance and a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO standards, cGMP/CGTP, and other relevant regulations/standards, and internal policies and procedures.
Manage direct reports.
Provide constructive feedback and guidance to develop leadership in direct reports and department management.
Establish and monitor objective annual goals for direct reports.
Conduct performance reviews and establish performance improvement plans as needed.
Recruit, interview, and select personnel for hire.
Travel domestically up to 25% to attend offsite meetings, conferences, and support business initiatives.
Maintain acceptable attendance and punctuality for scheduled work hours and meetings.
Ensure completion of assigned tasks and responsibilities within defined timeframes.
Maintain flexibility to work outside of normal business hours during weekdays or weekends with reasonable advance notice to support business/operational needs when necessary.
Perform other duties as assigned.
Qualifications/Requirements
Bachelor’s degree in a biological science, engineering, or related field required.
Master’s degree in a biological science, engineering, or related field preferred.
At least 8-10 years of experience in an FDA-regulated environment for HCT/Ps, medical devices, and/or pharmaceutical manufacturing, with at least 3 years in a management role for quality assurance, regulatory affairs, and/or engineering.
Clearance of favorable background investigation required.
Seniority level
Director
Employment type
Full-time
Job function
Quality Assurance
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role at
Tiger BioSciences LLC
seeks a leader to oversee the quality management system, including design control, design verification/validation, design history files, and risk assessment to ensure compliance with SOPs, FDA regulations, AATB Standards, ISO standards, and other applicable regulations and industry standards. This role drives quality engineering best practices and collaborates cross-functionally across the organization.
Responsibilities
Develop, implement, and maintain standardized processes in the Quality Management System to ensure compliance with relevant standards and regulations.
Oversee management, review, and approval of quality event investigations from initiation to closure for complaints, deviations, non-conformances, CAPAs, and SCARs; ensure timely completion, appropriate root cause analysis, and effective corrective/preventive actions.
Oversee, lead, and manage quality system related meetings, including management review.
Lead and/or support risk management initiatives by identifying, addressing, and escalating risks/issues as necessary.
Lead and support continuous improvement initiatives to enhance quality system processes.
Oversee and manage use of quality system software.
Lead and provide organizational training and guidance on quality standards, processes, procedures, and corrective/preventive actions.
Oversee management and coordination of training requirements/assignments.
Manage the quality data collection and reporting processes, including tracking and analyzing key performance indicators (KPIs).
Oversee supplier management program to ensure appropriate qualification and maintenance of the approved supplier list.
Support documentation requests from regulatory affairs to support regulatory submissions (e.g., PMA supplements, 510(k) submissions).
Manage internal audit program and schedule to assess and maintain compliance of the quality management system with regulations/standards, and internal policies and procedures.
Direct and lead internal, client, and regulatory agency audits to ensure compliance with regulatory requirements, accreditation/certification requirements, and internal policies and SOPs.
Develop and maintain professional working relationships with current and potential customers, consultants, suppliers, and vendors.
Establish and execute continuing education strategy for the department.
Promote shared leadership and foster collaboration across multi-disciplinary teams.
Maintain company compliance and a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO standards, cGMP/CGTP, and other relevant regulations/standards, and internal policies and procedures.
Manage direct reports.
Provide constructive feedback and guidance to develop leadership in direct reports and department management.
Establish and monitor objective annual goals for direct reports.
Conduct performance reviews and establish performance improvement plans as needed.
Recruit, interview, and select personnel for hire.
Travel domestically up to 25% to attend offsite meetings, conferences, and support business initiatives.
Maintain acceptable attendance and punctuality for scheduled work hours and meetings.
Ensure completion of assigned tasks and responsibilities within defined timeframes.
Maintain flexibility to work outside of normal business hours during weekdays or weekends with reasonable advance notice to support business/operational needs when necessary.
Perform other duties as assigned.
Qualifications/Requirements
Bachelor’s degree in a biological science, engineering, or related field required.
Master’s degree in a biological science, engineering, or related field preferred.
At least 8-10 years of experience in an FDA-regulated environment for HCT/Ps, medical devices, and/or pharmaceutical manufacturing, with at least 3 years in a management role for quality assurance, regulatory affairs, and/or engineering.
Clearance of favorable background investigation required.
Seniority level
Director
Employment type
Full-time
Job function
Quality Assurance
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