Director, Global CRO Quality

NAMSA•Minneapolis, MN

About The Position

NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976. We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry’s premier provider. We provide support for clients during every step of the product development lifecycle and beyond. Come and work for an organization with the: Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core Values: Act with integrity in everything we do. Provide best-in-class customer experiences. Develop superior talent and deliver expertise. Respond with agility and provide timely results. Embrace collaboration, diverse perspectives and ideas. Job Description: • Manages the Quality Management System(s) and Clinical Systems (GCP) at NAMSA. Duties include reviewing and analyzing procedure changes to assure compliance to relevant regulations. • Ensure compliance of the QMS and GCP regulations to all relevant industry standards and regulations. ISO 14155, ISO 9001, 21 CFR Parts 11, 50, 54, 56, 812 and 820 (FDA QSR), and EU Medical Device Regulation. • Drives Quality System integration activities for NAMSA acquired CRO entities working in conjunction with CRO Operational Leaders, QA Intergation Lead and VP QA/RA. • Assists in making recommendations and identifies improvements related to tools, systems and processes that align with the strategic direction of NAMSA global quality team. • Works closely with all Quality and business leaders when quality issues arise, ensuring proper trending, investigation, and closure of quality events as well as identifying and implementing mitigation strategies to reduce risk and recurrence. • Implement key process indicators in alignment with organizational goals for quality processes, sets goals, monitor, trend and report, review, communicate and assures understanding of the performance. Use these results to drive process improvements. • Will serve as a Management representative for CRO Business unit. • Lead Management review meetings. Sets the agenda and reports on the status of the quality system functions including internal/external audit results, complaints, Quality Index (KPI) and other updates as necessary. • Monitor changes to regulations in regards to Quality systems (QMS) and Clinical Systems (GCP) and operational compliance to ensure continued compliance to various global initiatives, legislation, regulations, standards, and laws. • Leading front room with Client clinical, QMS, and regulatory audits (e.g. FDA, ISO, BIMO) • Participate on project teams, consult with and advise Clinical Associates, Managers, and project teams, on GCP compliance issues. • Support clinical study teams and help to troubleshoot clinical compliance issues, including review and approval of Clinical SOPs and Work Instructions. • Oversee management of Internal Clinical audit program, to ensure risk based approach to clinical project audits and establishing systems to support mitigation activities and ensuring compliance to applicable regulatory requirements. • Manage direct associates development, mentorship and career growth. • Provides global training on quality system elements and continuous improvement topics. • Develop, revise, and implement policies and procedures, as required, in collaboration with management. • Ensure appropriate verification and validation of software and inspect validation documents. • Monitor adherence of company to Policies and Procedures.

Requirements

Bachelor’s degree or higher
At least ten years of experience in quality assurance or clinical research with human subjects and Quality Management systems( QMS)
Knowledge of appropriate regulations and guidelines, especially ISO 9001:2015, ISO 14155, 21 CFR Parts 11, 312 and 812, MedDev, EUMDR, GDPR, and 21 CFR Parts 11, 50, 54, 56 and 812.
Proficiency with standard computing (PC or Mac) and basic software application.
Proficiency with process development and technical writing.
Must be able to work independently and autonomously.
Must possess excellent verbal and written communication skills.
Strong organizational skills with attention to detail.
Demonstrate a high degree of personal and professional integrity.

Nice To Haves

ASQ, SQA or equivalent certification preferred
Demonstrated ability to establish and maintain relationships with clients and internal Associates
The employee must be able to work in a fast-paced environment with demonstrated ability to juggle and prioritize multiple, competing tasks and demands and to seek assistance as appropriate

Responsibilities

Manages the Quality Management System(s) and Clinical Systems (GCP) at NAMSA.
Ensure compliance of the QMS and GCP regulations to all relevant industry standards and regulations. ISO 14155, ISO 9001, 21 CFR Parts 11, 50, 54, 56, 812 and 820 (FDA QSR), and EU Medical Device Regulation.
Drives Quality System integration activities for NAMSA acquired CRO entities working in conjunction with CRO Operational Leaders, QA Intergation Lead and VP QA/RA.
Assists in making recommendations and identifies improvements related to tools, systems and processes that align with the strategic direction of NAMSA global quality team.
Works closely with all Quality and business leaders when quality issues arise, ensuring proper trending, investigation, and closure of quality events as well as identifying and implementing mitigation strategies to reduce risk and recurrence.
Implement key process indicators in alignment with organizational goals for quality processes, sets goals, monitor, trend and report, review, communicate and assures understanding of the performance. Use these results to drive process improvements.
Will serve as a Management representative for CRO Business unit.
Lead Management review meetings.
Monitor changes to regulations in regards to Quality systems (QMS) and Clinical Systems (GCP) and operational compliance to ensure continued compliance to various global initiatives, legislation, regulations, standards, and laws.
Leading front room with Client clinical, QMS, and regulatory audits (e.g. FDA, ISO, BIMO)
Participate on project teams, consult with and advise Clinical Associates, Managers, and project teams, on GCP compliance issues.
Support clinical study teams and help to troubleshoot clinical compliance issues, including review and approval of Clinical SOPs and Work Instructions.
Oversee management of Internal Clinical audit program, to ensure risk based approach to clinical project audits and establishing systems to support mitigation activities and ensuring compliance to applicable regulatory requirements.
Manage direct associates development, mentorship and career growth.
Provides global training on quality system elements and continuous improvement topics.
Develop, revise, and implement policies and procedures, as required, in collaboration with management.
Ensure appropriate verification and validation of software and inspect validation documents.
Monitor adherence of company to Policies and Procedures.