Vice President, Quality (ADX-34-21) at ArcherDX
Vice President, Quality (ADX-34-21)
In October 2020, Invitae Corporation (NYSE: NVTA) combined with ArcherDX, a genomic analysis company specializing in cancer diagnostics and monitoring, to create a leading comprehensive medical and cancer genetics company. As a combined company, Invitae, is bringing world-class genetic testing and diagnostics into mainstream medicine to improve healthcare for billions of people. Our goal is to aggregate the world’s genetic tests into a single service with higher quality and accuracy, faster turnaround time and actionable results. Learn more at invitae.com and archerdx.com.
The VP of Quality, reporting to the Chief of Diagnostic Strategy, will establish, oversee, and manage Software and Design Quality, Manufacturing Quality Operations and Quality Systems, and be a key cross functional leader supporting continuous improvement programs. The VP of Quality will implement and maintain a statistical based quality system, develop and maintain quality systems in compliance with US FDA Regulations and ISO 13485:2016 standards, and maintain supplier quality relationships. They will provide leadership to establish and maintain quality levels that meet and exceed customer expectations.
Job performance will involve a variety of activities including:
- Determine the overall quality strategy for the Oncology division, to align with ArcherDX's overall strategic plan.
- Represent the Quality organization to executive management and other leadership forums with competence, professionalism, and strategic vision.
- Build strong quality systems for determining the appropriate infrastructure and resources required for each sub-department to achieve business objectives.
- Define and champion a Quality Policy which enables continuous improvement, compliance to relevant quality standards and regulations, and enables efficient fulfillment of ArcherDX’s mission and initiatives.
- Oversee all quality assurance activities, including planning, coordination, and implementation efforts for compliance with all cGMPs, regulations, laws and internal SOPs and WIs through audit, inspection and training of personnel.
- Ensure internal processes and metrics are aligned to manufacture/design the highest product quality and competitive advantage.
- Accountable for implementing and maintaining the necessary programs to support the Corporate Quality Policy, the Quality System, and the CI initiatives.
- Represent ArcherDx in discussions, inspections, and other audiences with regulatory authorities.
- Provide training, 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.
- Minimum of 15 year’s experience in Quality Assurance/Quality Control, with at least 7 years in a leadership position.
- Minimum of 10 years experience in the medical device industry, with at least 5 year of experience in IVD devices specifically.
- Strong knowledge of 21 CFR 820 and ISO 13485:2016 to ensure compliance with all FDA regulations; international experience a plus
- Working knowledge of global regulatory submissions and typical content included therein
- Direct experience being interviewed in inspections and audits, and familiarity with audit support practices
- Previous demonstration of Director level leadership 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 leadership and communication skills
- Driven to perform
- Self-directed: needs little explicit direction
- Able to organize, prioritize, and delegate tasks to efficiently move projects forward
Bachelor's degree required. Master’s Degree preferred.