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Manager, Clinical Quality Assurance

Date: Jan 4, 2019

Location: Lakewood, CO, US

Company: Terumo BCT, Inc.

Requisition ID:  22765  

 

JOB SUMMARY

Responsible for leading activities that result in being an organization that is “Audit Ready”. The primary responsibilities include: developing and leading the Clinical Quality Assurance (CQA) processes to maintain a state of audit readiness, supporting vendor qualification and management activities, leading Terumo BCT Global Clinical Affairs standard operating procedure (SOP) development and maintenance, investigation of high risk quality concerns, and providing interpretation and application of current and upcoming regulations in the industry.

 

The CQA Manager will maintain the Global Clinical Affairs Quality Systems and infrastructure appropriate for product development in compliance with in compliance with all applicable regulatory and Good Clinical Practice (GCP) requirements. This organized, self-starter will manage 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 Clinical Affairs 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 and prepare the company to successfully commercialize products.

 

ESSENTIAL DUTIES

  • Develop and execute risk-based quality assurance strategies to support the Global Clinical Affairs 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
  • Promote quality mindset at all levels within the organization
  • Lead role in supplier/vendor qualification and compliance oversight process, including conduct and/or support of audit activities
  • Participate, support and/or assist staff during regulatory inspections (e.g. bioresearch monitoring program (BIMO))
  • 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
  • Manage and oversee audit responses
  • Track CAPAs for completion
  • Develop and implement CQA processes and process improvements
  • 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 clinical trial documents and content including but not limited to clinical protocols, study reports, and clinical sections of regulatory submissions
  • May participate as a QA member of the project team for clinical studies
  • Hire, train, coach, counsel, and evaluate the performance of direct reports
  • Responsible for development and ongoing review of Clinical Affairs policies, procedures and controlled documents
  • Produce training material and conduct training sessions regarding compliance to Clinical Affairs policies, procedures, standards, regulations, and guidelines
  • Communicate necessary information to teams, organization, and external clients

 

MINIMUM QUALIFICATION REQUIREMENTS

 

Education

Bachelor’s degree or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.

 

Experience

  • Minimum of 10 years of clinical trial experience in the biologics, pharmaceutical, or medical device industries.
  • Minimum of 5 years experience in Clinical QAand GCP auditing.
  • Experience in clinical trial execution preferred.
  • In-depth knowledge/experience in GCP auditing activities and evidence of monitoring compliance with SOPs, GCP, and FDA regulations.  Global GCP experience preferred.
  • Experience managing direct reports preferred.

 

Skills

  • Knowledge of U.S. and international medical device regulations and standards including 21 CFR 312, 21 CFR 812, ICH E6 (R2), EU Medical Device Regulations, and ISO 14155.
  • 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 Affairs
  • Strong written and verbal communication skills, organizational, analytical problem solving, and conflict resolution skills.
  • Ability to work independently and to work interactively with multidisciplinary teams to facilitate results.
  • 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.
  • Solicits and accepts the ideas of others, as well as actively contributes to an environment conducive to open communication.
  • Capability to interact with diplomacy and tact while maintaining appropriate assertiveness.
  • Demonstrated ability to communicate effectively both verbally and in writing.
  • Must be detail oriented, well organized and able to work independently and in teams.
  • Demonstrated ability to lead people and get results through others.
  • Knowledge and use of relevant PC software applications and skills to use them effectively.

 

-Or-

 

An equivalent competency level acquired through a variation of these qualifications may be considered.

 

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

Requires travel based on business needs.

 

 

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 BCT is committed to providing a safe and secure working environment.  We maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification checks.  To this end, all employment offers for positions in the U.S. are conditional upon successful completion of Terumo BCT's pre-employment screening process.  As of January 1, 2017 the Terumo BCT Lakewood, Colorado location will be a tobacco-free workplace. For more information about Terumo BCT, visit our website www.terumobct.com/careers.


Join Terumo BCT as we unlock the potential of blood. We are a global leader in blood component and cellular technologies, and the only company with the unique combination of apheresis collections, manual and automated whole blood processing, and pathogen reduction coupled with leading technologies in therapeutic apheresis and cell processing. We believe in the potential of blood to do even more for patients than it does today. This belief inspires our innovation and strengthens our collaboration with customers.

 

As the largest medical device manufacturing company headquartered in Colorado, we are home to more than 2,300 associates and our products are in use in more than 125 countries and territories. Our Global footprint includes more than 5,500 associates and partners with regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo.

 

Our company has almost $1B in annual revenues and has been voted and recognized as:

  • Largest corporate sponsor in Rocky Mountain Region for Leukemia and Lymphoma Society (LLS)
  • Winner of the Association for Talent Development (ATD) BEST Award for providing exceptional employee learning and talent development (2011 & 2012)
  • One of Colorado’s Healthiest Employers by Denver Business Journal (2014 & 2015)
  • Recipient of the Way to Go Employer award through the Denver Regional Council of Governments (DRCOG) 2015

 

Our award-winning culture embraces:

  • Leading technology through innovation and R&D
  • Wellness programs
  • Commitment to quality
  • An environment that values, respects and rewards your individual contributions
  • A philosophy of intentional growth and responsiveness to world health issues

 

Click Here to see what our associates have to say about our culture.

 

Each associate has a positive impact on our future by:

  • Connecting to the lives of the patients we ultimately serve
  • Growing through professional and leadership development activities
  • Sharing company success through incentive plans

 

If you are the best at what you do and want to do work that is changing the delivery of healthcare globally, we invite you to work with us now to see how we can unlock your potential.


Nearest Major Market: Denver

Job Segment: Clinic, Product Development, Pharmaceutical, Medical, R&D, Healthcare, Research, Science