What are the responsibilities and job description for the Mgr Clinical Quality Assurance position at Terumo BCT, Inc.?
Requisition ID: 29602
At Terumo Blood and Cell Technologies, our 7,000 global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world.
We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve.
With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Consider joining our team and unlock your potential.
JOB TITLE: Clinical Quality Assurance Manager
JOB SUMMARY
The Clinical Qualtiy Assurance Manger is responsible for assuring the quality of clinical development systems, processes and related activities. The primary responsibilities include: developing and leading the Clinical Quality Assurance (CQA) processes to maintain a state of compliance, supporting vendor qualification and management activities, leading standard operating procedure (SOP) development and maintenance, documentation reviews, as appropriate, and providing interpretation and application of current and upcoming regulations in the industry.
The CQA Manager will maintain the TRI Quality Systems and infrastructure appropriate for product development in compliance with in compliance with all applicable regulatory and Good Clinical Practice (GCP) requirements. Manages quality requirements for the conduct of clinical trials, ensuring the realization of industry best practice activities while remaining adaptable to the changing needs of program development.
Responsible for working with department leadership to direct, implement and maintain the clinical quality initiatives for clinical trials and registries, including compliance with regulatory agencies and other objectives. The CQA Manager will work dynamically and proactively with Terumo BCT Quality and other functional area leads to facilitate development of GxP-compliant procedures to support conduct of clinical studies
ESSENTIAL DUTIES
Develop and execute risk-based quality assurance strategies to support the department activities, which include audit planning, conduct, documentation and follow-up of planned activities
Monitor relevant agency compliance rulings and communications
Maintain a working knowledge of International Organization for Standardization (ISO), GCP requirements, industry practices, International Conference on Harmonization (ICH) Guidelines, internal policies, and procedures that affect regulatory compliance
Develop, implement, and execute a compliance auditing program to ensure the fulfillment of regulatory requirements
Conduct internal CQA audits to identify non-compliance related to adherence to SOPs, regulations, and GCP
Develop audit schedules and manage and/or conduct global GCP audits
Develop and deliver GCP training programs or revisions to training curricula
Play a lead role in supplier/vendor qualification and compliance oversight process, including conduct and/or support of audit activities
Participate and/or support staff during regulatory inspections (e.g., bioresearch monitoring program (BIMO))
ADDITOINAL DUTIES
Conduct and/or support investigative site audits and associated activities
Prepare and/or review written reports for audits and inspections
Review and monitor Corrective and Preventive Action Plans (CAPA) identified internally and/or externally and assist in root cause analysis and formulating responses
Participate in in the development, implementation, and maintenance of SOPs and CQA activities
Provide ad-hoc, CQA-related expertise in partnering with internal customers cross-functionally to effectively manage clinical trials
Oversee and/or conduct CQA review of core documents and content including but not limited to clinical protocols, study reports, clinical sections of regulatory submissions, and publications
Hire, train, coach, counsel, and evaluate the performance of direct reports
MINIMUM QUALIFICATION REQUIREMENTS
Education
Bachelor’s degree in Science or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
Strongly prefer relevant auditing and certification in Quality Assurance and Good Clinical Practices.
Experience
Minimum of 5 years of experience in the biologics, pharmaceutical, or medical device industries
Minimum of 5 years direct clinical auditing experience in Quality Assurance or CRA, and GCP auditing, preferred
Experience in clinical trial execution preferred
In-depth knowledge/experience in GCP auditing activities and evidence of monitoring compliance with SOPs, GCP, and FDA and EU regulations. Global GCP experience preferred
Demonstrated ability to analyze laws, regulations, and guidelines and apply them in practice.
Minimum of four years of supervisory experience
Skills
Knowledge of U.S. and international medical device regulations and standards including 21 CFR 312, 21 CFR 803, 820, 812,and 814, ICH E-6 , EU Medical Device Regulations, ISO 14155, ISO 13485, and ISO 14971.
Maintains expert knowledge of current industry standards, quality improvement activities, and strong management skills
Maintain knowledge of FDA and other global regulatory agencies’ activities, regulations and guidelines relevant to Clinical Investigations
Ability to work independently and to work interactively with multidisciplinary teams to facilitate results.
Strong written and verbal communication skills, organizational, analytical problem solving, and conflict resolution skills.
Strong interactive skills in cross functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross functional team member, team behavior, and support for subordinates and management
PHYSICAL REQUIREMENTS
Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.
The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.
Additional Physical Requirements
Travel required, up to 15%
Target Pay Range: $109,400.00 to $136,700.00 - Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data
Target Bonus on Base: 10.0%
At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family. Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more. To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates. For us, it’s about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind.
Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan.
In 2019, Terumo Blood and Cell Technologies reached $1 billion in revenue.
We employ nearly 7,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo.
We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries.
Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare.
Respect – Appreciative of others
Integrity – Guided by our mission
Care – Empathetic to patients
Quality – Committed to excellence
Creativity – Striving for innovation
We contribute to the Leukemia and Lymphoma Society (LLS), raising $1.3 million USD since 2007.
We are proud to be an Equal Opportunity Affirmative Action Employer. All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service.
Terumo Blood and Cell Technologies is committed to providing a safe, healthy and secure working environment. Our Colorado campus locations are tobacco-free workplaces and we maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification. Absent accommodation permitted by applicable law, as a condition of employment with Terumo Blood and Cell Technologies in the United States you must be fully COVID-19 vaccinated and provide valid proof of vaccination to the company.
Nearest Major Market: Denver
Job Segment: Medical Device, Quality Assurance, Pharmaceutical, Medical Research, Clinical Research, Healthcare, Technology, Science
At Terumo Blood and Cell Technologies, our 7,000 global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world.
We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve.
With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Consider joining our team and unlock your potential.
JOB TITLE: Clinical Quality Assurance Manager
JOB SUMMARY
The Clinical Qualtiy Assurance Manger is responsible for assuring the quality of clinical development systems, processes and related activities. The primary responsibilities include: developing and leading the Clinical Quality Assurance (CQA) processes to maintain a state of compliance, supporting vendor qualification and management activities, leading standard operating procedure (SOP) development and maintenance, documentation reviews, as appropriate, and providing interpretation and application of current and upcoming regulations in the industry.
The CQA Manager will maintain the TRI Quality Systems and infrastructure appropriate for product development in compliance with in compliance with all applicable regulatory and Good Clinical Practice (GCP) requirements. Manages quality requirements for the conduct of clinical trials, ensuring the realization of industry best practice activities while remaining adaptable to the changing needs of program development.
Responsible for working with department leadership to direct, implement and maintain the clinical quality initiatives for clinical trials and registries, including compliance with regulatory agencies and other objectives. The CQA Manager will work dynamically and proactively with Terumo BCT Quality and other functional area leads to facilitate development of GxP-compliant procedures to support conduct of clinical studies
ESSENTIAL DUTIES
Develop and execute risk-based quality assurance strategies to support the department activities, which include audit planning, conduct, documentation and follow-up of planned activities
Monitor relevant agency compliance rulings and communications
Maintain a working knowledge of International Organization for Standardization (ISO), GCP requirements, industry practices, International Conference on Harmonization (ICH) Guidelines, internal policies, and procedures that affect regulatory compliance
Develop, implement, and execute a compliance auditing program to ensure the fulfillment of regulatory requirements
Conduct internal CQA audits to identify non-compliance related to adherence to SOPs, regulations, and GCP
Develop audit schedules and manage and/or conduct global GCP audits
Develop and deliver GCP training programs or revisions to training curricula
Play a lead role in supplier/vendor qualification and compliance oversight process, including conduct and/or support of audit activities
Participate and/or support staff during regulatory inspections (e.g., bioresearch monitoring program (BIMO))
ADDITOINAL DUTIES
Conduct and/or support investigative site audits and associated activities
Prepare and/or review written reports for audits and inspections
Review and monitor Corrective and Preventive Action Plans (CAPA) identified internally and/or externally and assist in root cause analysis and formulating responses
Participate in in the development, implementation, and maintenance of SOPs and CQA activities
Provide ad-hoc, CQA-related expertise in partnering with internal customers cross-functionally to effectively manage clinical trials
Oversee and/or conduct CQA review of core documents and content including but not limited to clinical protocols, study reports, clinical sections of regulatory submissions, and publications
Hire, train, coach, counsel, and evaluate the performance of direct reports
MINIMUM QUALIFICATION REQUIREMENTS
Education
Bachelor’s degree in Science or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
Strongly prefer relevant auditing and certification in Quality Assurance and Good Clinical Practices.
Experience
Minimum of 5 years of experience in the biologics, pharmaceutical, or medical device industries
Minimum of 5 years direct clinical auditing experience in Quality Assurance or CRA, and GCP auditing, preferred
Experience in clinical trial execution preferred
In-depth knowledge/experience in GCP auditing activities and evidence of monitoring compliance with SOPs, GCP, and FDA and EU regulations. Global GCP experience preferred
Demonstrated ability to analyze laws, regulations, and guidelines and apply them in practice.
Minimum of four years of supervisory experience
Skills
Knowledge of U.S. and international medical device regulations and standards including 21 CFR 312, 21 CFR 803, 820, 812,and 814, ICH E-6 , EU Medical Device Regulations, ISO 14155, ISO 13485, and ISO 14971.
Maintains expert knowledge of current industry standards, quality improvement activities, and strong management skills
Maintain knowledge of FDA and other global regulatory agencies’ activities, regulations and guidelines relevant to Clinical Investigations
Ability to work independently and to work interactively with multidisciplinary teams to facilitate results.
Strong written and verbal communication skills, organizational, analytical problem solving, and conflict resolution skills.
Strong interactive skills in cross functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross functional team member, team behavior, and support for subordinates and management
- Or-
PHYSICAL REQUIREMENTS
Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.
The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.
Additional Physical Requirements
Travel required, up to 15%
Target Pay Range: $109,400.00 to $136,700.00 - Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data
Target Bonus on Base: 10.0%
At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family. Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more. To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates. For us, it’s about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind.
Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan.
In 2019, Terumo Blood and Cell Technologies reached $1 billion in revenue.
We employ nearly 7,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo.
We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries.
Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare.
Respect – Appreciative of others
Integrity – Guided by our mission
Care – Empathetic to patients
Quality – Committed to excellence
Creativity – Striving for innovation
We contribute to the Leukemia and Lymphoma Society (LLS), raising $1.3 million USD since 2007.
We are proud to be an Equal Opportunity Affirmative Action Employer. All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service.
Terumo Blood and Cell Technologies is committed to providing a safe, healthy and secure working environment. Our Colorado campus locations are tobacco-free workplaces and we maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification. Absent accommodation permitted by applicable law, as a condition of employment with Terumo Blood and Cell Technologies in the United States you must be fully COVID-19 vaccinated and provide valid proof of vaccination to the company.
Nearest Major Market: Denver
Job Segment: Medical Device, Quality Assurance, Pharmaceutical, Medical Research, Clinical Research, Healthcare, Technology, Science
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