Global Audit Manager

Requisition ID: 33402

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. For Terumo, for Everyone, Everywhere.

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. Advancing healthcare with heart.

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. Join us and help shape wherever we go next. You create your future and ours.

We are seeking aGlobal Audit Manager to join our team in Lakewood, Colorado. In this critical role, you'll oversee internal, external, and supplier audits, serve as a key contact for regulatory compliance, and champion continuous improvement initiatives. With responsibilities ranging from managing cross-functional teams and interfacing with global regulatory authorities to mentoring and developing an audit team, you'll be instrumental in ensuring compliance with U.S. and international medical device regulations. Bring your passion for quality, strong leadership skills, and expertise in FDA Quality System Regulation and ISO 13485 to make a tangible impact in advancing patient care.

ESSENTIAL DUTIES

• QMS area of ownership, management, and responsibility: Audit (internal, external, supplier).
• Serves as Audit expert and main point of contact for regulatory / compliance issues.
• Acts as the policy / procedure owner for area(s) of responsibility, ensuring they are compliant and effective and ensures the cross-functional organization understands and supports QMS Audit activities as needed.
• Executes their QMS area(s) in accordance with governing internal policies / procedures and external standards and regulations. This likely includes: generation and approval of annual schedules, execution to schedule, approval of plans or reports, follow up on action items, facilitation of discussions with participants and stakeholders to ensure success and compliance.
• Supports the remediation of internal site audits and regulatory audits.
• Monitors and reports the health of the QMS areas(s) within their area of responsibility, and provides metrics to management as required, including any governing oversight boards. Identifies and implements continuous improvement opportunities within their area(s) of responsibility.
• Serves as Subject Matter Expert and Process Owner for their QMS area(s) of responsibility during audits and inspections.
• Acts as a Audit host or backroom leader when requested.
• Influences the organization in quality objectives, prioritization and resourcing decisions as necessary.
• Manages team of direct reports in support of the above (as applicable).
• Manages and provides operational leadership for the audit team's development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.
• Acts as an internal champion for quality initiatives aimed at improving business systems and compliance; may be the primary representative of Quality group on projects.
• During audits and inspections, interfaces with global regulatory authority, notified body auditors and provides general support for the Quality group.
• Interfaces with QMS area owners and project teams from other Terumo BCT locations, regions, and corporate.

MINIMUM QUALIFICATION REQUIREMENTS

Education

Bachelor's degree in a science related field (Science, Technology, Engineering or Mathematics).

Experience

• Preferred minimum 7 years of experience in Quality Assurance and /or Regulatory Affairs, involving US FDA Class II or Class III medical devices including knowledge & experience of applying global device laws & regulations for adverse event reporting and product recalls.
• Minimum 2 years of supervisory experience.
• Preferred training in FDA Quality System Regulation and ISO 13485.
• Hosted and/or led 10+ regulatory audits (e.g., MDSAP, FDA, Notified Body).

Skills

• Knowledge of U.S. and international medical device regulations and standards (CFR 820, MDD and ISO 13485).

• Stronginteractive 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, quality specialists, 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.
• Knowledge and use of relevant PC software applications and skills to use them effectively.
• Must be detail oriented, well organized and able to work independently and in teams.
• Demonstrated ability to lead people and get results through others.

-Or-

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

LOCATION

Lakewood, Colorado - Open to candidates willing to relocate to the area.

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.

Target Pay Range:$120,400.00to$150,600.00 -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.