Senior Manager/ Associate Director of Quality Analytical Services (ADX-215-19) at ArcherDX
THE COMPANY: ArcherDX, Inc. - www.ArcherDX.com
ArcherDX is advancing molecular diagnostics with a robust technology platform for genetic mutation detection by next-generation sequencing. By combining patented Anchored Multiplex PCR (AMP™) chemistry in an easy-to-use, lyophilized format and powerful bioinformatics software, the Archer® platform enhance genetic mutation identification. ArcherDX provides oncology-focused research products and is pursuing regulatory approval for multiple companion diagnostic assays. ArcherDX is headquartered in Boulder, Colorado. Learn more at www.archerdx.com and follow @ArcherDXInc on Twitter, Facebook and LinkedIn.
- Determine the overall quality and continuous improvement strategy for the Quality Analytical services department, to align with ArcherDX's overall strategic plan, Corporate Quality Policy, the Quality System, and the CI initiatives as they relate to the Quality Analytical services department.
- Organize and oversee the management of the Quality Control and Test Method Validation groups, approving plans and expenditures necessary to achieve objectives.
- Build strong quality systems within the laboratory for determining the appropriate infrastructure and resources required for the Quality Analytical services department to achieve business objectives.
- Ensure internal laboratory processes and metrics are aligned to create the highest product quality and competitive advantage.
- Provide analytical quality leadership throughout the product development process and ensure proper interface to product development and manufacturing services.
- Oversee investigations of laboratory issues to ensure timely closed-loop corrective actions and reports as required.
- Provide training and leadership and represent a positive and enthusiastic role model to ensure high engagement across the team.
- Coach team leaders on leadership development and assists in creating development and training plans.
- Perform other duties as assigned by supervisor
- Review, understanding, and compliance with ArcherDX HIPAA Security policies and procedures.
- Safeguarding the privacy and security of protected health information and European Union personal data.
- Processing and handling of European Union personal data only as directed by ArcherDX for purposes of personalized molecular pathology.
- Drive and determination
- Ability to work in a fast-paced and dynamic environment
- Ability to participate with others as a member of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively to enhance the success of the projects and maintain strong relationships within all parts of the company.
- Strong communication and presentation skills
- Driven to perform
- Self-directed: needs little explicit direction
- Able to organize, prioritize, and delegate tasks to efficiently move projects forward.
- Associate Director: Minimum of 10 years experience in Quality roles with a minimum of 8 years in a laboratory setting and 5 years in a leadership position
- Senior Manager: Minimum of 7 years experience in Quality roles with a minimum of 5 years in a laboratory setting and 3 years in a leadership position
- Knowledge of cGMP/CFR/FDA regulations
- Ability to ensure continued compliance with all FDA regulations, International experience a plus
- Previous demonstration of director/managerial and administrative skills
- Strong leadership and communication skills
- Bachelor's degree required. Master’s Degree preferred.