Associate Director / Director of Quality Manufacturing and Operations (ADX-253-20)
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.
The Associate Director / Director of Quality Manufacturing and Operations, reporting to the VP of Quality Control and Manufacturing Engineering, will establish, oversee, and manage the Manufacturing Quality and Continuous Improvement programs. They will provide leadership to establish and maintain quality levels that meet and exceed customer expectations. The Associate Director / Director of Quality Manufacturing and Operations will implement and maintain a statistical based quality system, develop and maintain manufacturing quality systems in compliance with US FDA Regulations and ISO 13485:2016 standards, and maintain supplier quality relationships. Function includes management and oversight over Manufacturing Quality Department; assurance that relevant procedures are managed and continuously reviewed and improved for compliance and operating efficiencies; ensures that Manufacturing QA department personnel are trained; ensures compliance to medical device and in vitro diagnostic regulations, relevant to the scope of department.
Job performance will involve a variety of activities including:
- Determine the overall quality and continuous improvement strategy for department, to align with ArcherDX's overall strategic plan.
- Build strong quality systems for determining the appropriate infrastructure and resources required for department to achieve business objectives.
- Ensure internal processes and metrics are aligned to create highest product quality and competitive advantage.
- Provide Supplier and Manufacturing Quality leadership throughout the product development process.
- Provide leadership and guidance to ensure proper interface of Supplier and Manufacturing Quality to marketing, business development, and product development.
- Implement and maintain the necessary programs to support the Corporate Quality Policy, the Quality System, and the CI initiatives, as they relate to Supplier and Manufacturing Quality.
- Oversee investigations of Supplier and Manufacturing quality issues to insure timely closed loop corrective actions and reports as required.
- Oversee the management of Nonconformance Reporting, Investigation and Disposition.
- Support supplier quality programs; conduct supplier audits as needed to meet objectives.
- Partner with the Directors of Manufacturing and Supply Chain to create and direct programs to ensure the quality of the product.
- 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.
- Oversee compliant Purchasing and Manufacturing Document management and retention
- 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.
- Minimum of 12 year’s experience in Quality Assurance/Quality Control with 5 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
- 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. is
- Bachelor's degree required. Master’s Degree preferred.