Sr. Manager of Manufacturing Quality Operations (ADX-316-20)
Sr. Manager of Manufacturing Quality Operations (ADX-316-20)
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.
POSITION SUMMARY:
The Senior Manager of Manufacturing Quality Operations, reporting to the Associated Director, Quality Manufacturing and Operations, 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 Senior Manager of Manufacturing Quality 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, and maintain supplier quality relationships. Function includes management and oversight over the Regulated Products Manufacturing Quality Department; assurance that relevant procedures are managed and continuously reviewed and improved for compliance and operating efficiencies; ensures that Manufacturing Quality Department personnel are trained; ensures compliance to medical device and in vitro diagnostic regulations, relevant to the scope of department.
RESPONSIBILITIES:
Job performance will involve a variety of activities including:
Determine the overall quality and continuous improvement strategy for the department, to align with ArcherDX's overall strategic plan.
Organize and oversee management of the Regulated Product Manufacturing Quality department, approving plans and expenditures necessary to achieve objectives.
Build strong quality systems for determining the appropriate infrastructure and resources required for the department to achieve business objectives.
Ensure internal processes and metrics are aligned to create highest product quality and competitive advantage.
Provide leadership and guidance to ensure proper interface of Supplier and Manufacturing Controls 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 Controls.
Review and Approve Supplier Quality Agreements and the Approved Supplier List.
Oversee investigations of Supplier and Manufacturing quality issues to ensure timely closed loop corrective actions and reports as required.
Oversee the management of Nonconformance Reporting, Investigation and Disposition.
Oversee the management of the Lot Release process.
Support supplier quality programs; conduct supplier audits as needed to meet objectives.
Partner with the managers of Manufacturing and Supply Chain to create 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.
Oversee compliant Purchasing, Engineering, 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.
EXPERIENCE:
Minimum of 10 years 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 managerial and administrative skills
Strong leadership and communication skills
KEY ATTRIBUTES:
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
Self-starter
Driven to perform
Self-directed: needs little explicit direction
Able to organize, prioritize, and delegate tasks to efficiently move projects forward
EDUCATION:
Bachelor's degree required. Master’s Degree preferred.