Clinical Trials Quality Consultant - Denver, CO

Job Description

Job Description

Position : Clinical Trials Quality Consultant

Location : Denver, CO

Pay Range : $1.00-$999.99 / hr

Exciting Opportunity : Senior Quality Consultant at Leading Life Sciences Company!

Are you a Quality Assurance expert with a passion for improving healthcare outcomes? Do you thrive in dynamic environments where your expertise can drive innovation?

Join our prestigious biomedical client as a Senior Quality Consultant and help shape the future of healthcare!

About the Company :

Our client is a pioneering Lifesciences company committed to advancing medical technologies and solutions that enhance patient care.

With a focus on innovation and excellence, they are at the forefront of transforming the healthcare landscape.

Key Responsibilities :

In this role, you will collaborate closely with quality managers and clinical trials coordinators to establish the necessary infrastructure for FDA approvals and audits.

As a Senior Quality Consultant, you will :

• Drive Quality Initiatives : Develop, implement, and manage quality management framework tailored for clinical trials, ensuring adherence to regulatory standards and industry best practices throughout the trial lifecycle.
• Act as Subject Matter Expert : Offer specialized knowledge and serve as a primary point of contact for all quality management initiatives.
• Establish Standard Operating Procedures (SOPs) : Craft detailed SOPs to enhance the effectiveness of quality management processes.
• Conduct Audits and Assessments : Perform internal and external quality audits, identifying areas for improvement and ensuring adherence to ISO, FDA, and other relevant regulations.
• Data-Driven Insights : Analyze quality metrics and trends, providing actionable recommendations to enhance processes and improve product quality.
• Mentor and Train : Offer guidance and training to foster a culture of quality and continuous improvement throughout the organization.

What You Bring :

• Experience : A minimum of 10+ years in quality assurance or quality management within the biomedical or medical device industry.
• Regulatory Knowledge : In-depth understanding of FDA regulations and other relevant quality standards in the biomedical field.
• Analytical Skills : Proven ability to analyze complex data and translate findings into strategic initiatives.
• Communication Skills : Exceptional interpersonal and communication abilities, capable of engaging stakeholders at all levels.
• Problem-Solver : A proactive approach to identifying challenges and implementing effective solutions in a fast-paced environment.

IND1

Working Conditions :

• May on occasion be exposed to loud sounds and distracting noise levels, such as from office equipment.
• The ability to lift up to 30 lbs.
• Use of computers and technology.

Here at Canon Recruiting, People are our priority, and we are committed to Include Diversity in every segment of who we are.

It is only through our Diversity, we are made a stronger organization, and increase our ability to provide top tier candidates that our clients have come to know Canon for.

We have an inclusive environment all employees are celebrated for their unique differences. The different perspectives and experiences of our workforce give us the competitive advantage that is essential for success in an ever-changing market.

By promoting inclusion with the same enthusiasm, we devote to quality and competency, and using the experience from a diverse assortment of backgrounds and experiences, Canon is able to improve the services and value we deliver to clients, employees, and customers.

At Canon, Diversification and Inclusiveness are much more than a corporate ambition; they are a critical component in our daily corporate life.

Canon Recruiting is committed to a diverse and inclusive workplace. Canon Recruiting is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.

The pay range for this position is listed above. Base pay information is based on market location. We will consider for employment qualified applicants with arrest and conviction records.

Our range of benefits may include health care and 401(k) savings plans. For individuals with disabilities who would like to request an accommodation, please email our HR team.