Senior Manager, Quality Assurance

AOA Dx is developing the next frontier in early-stage cancer detection through its pioneering work in glycolipids and proprietary biomarker technology. Our revolutionary tumor marker ganglioside platform, GlycoLocate™, is paving the way for life-saving early cancer detection. In a first of its kind, AOA Dx is developing AKRIVIS GD™, an early-stage liquid biopsy test for ovarian cancer.

We are seeking a Senior Manager, Quality Assurance to take on a pivotal role in building, maintaining and enhancing our Quality Management System (QMS) while ensuring regulatory compliance and resolving customer complaints. This role demands a diverse skill set, including leadership, technical expertise, and a commitment to continuous improvement.

You will build and maintain the Quality Management System (QMS), taking charge of major sub-systems including Document Control, Training Administration, CAPA, Change Management, Deviations, Complaint Handling, and Audit Programs. Leading continuous improvement projects will be a core responsibility, aimed at enhancing efficiency and effectiveness.

• Lead multi-site Quality Management Systems (QMS), overseeing activities related to CAPA, Deviation/Nonconformance, Complaints, Change Control, Audits, and Document/Record Management, along with Training Administration.
• Support the analysis and future QMS needs of the organization, ensuring harmonization across multiple sites.
• Act as Management Representative
• Compile and report Quality Metrics and Objectives to monitor QMS effectiveness and any need for improvement at both site and organizational levels.
• Execute and support QMS audit activities, including internal, client, due diligence, and regulatory audits, and lead response activities resulting from audits.
• Provide training on Quality Management Systems, including current Quality Management System Regulation and related standards.
• Support the implementation of software for GLP systems, contributing to configuration requirements, and validation execution, and development of procedures/work instructions.
• Support clinical quality activities.
• Supervise Quality Assurance/Document Control personnel.

Qualifications:

• Bachelor’s degree in engineering, science, technical field, or equivalent, with a minimum of 8 years of experience in developing, configuring, and maintaining Quality Management Systems. A combination of education and experience may be considered.
• Minimum of 3 years of experience supervising employees.
• Minimum of 8 years of experience in the medical device or biotechnology industry, with a strong focus on QMS, FDA 21 CFR Part 820 and ISO 13485 compliance.
• Quality Management experience in medical devices and diagnostics.
• Strong computer skills, including proficiency in Microsoft Office suite applications and basic proficiency in Adobe Acrobat.
• Ability to effectively train and educate stakeholders, partners, and management.
• Experience in developing and implementing QMS procedures.
• Experience in managing/conducting internal/supplier and external audits. Auditor certification preferred.
• Expertise in FDA 21 CFR Part 820, ISO 13485, and related regulations/standards.
• Experience in resolving customer complaints and managing the CAPA processes.
• Excellent communication, collaboration, and leadership skills.
• Ability to work independently and as part of a team in a fast-paced environment.

The salary range for this position is $145,000 to $155,000 per year, which factors in various geographic regions. The actual compensation and seniority level for this position will be determined based on relevant experience and qualifications.

AOA Dx offers competitive benefits, including unlimited PTO, group health, dental, and vision insurance, 100% employee sponsored life and disability benefits, monthly cell phone reimbursement, and a 401k plan with employer match.

For consideration, please apply via LinkedIn or email us with your resume referencing LeadQA in the subject line to: careers@aoadx.com

We foster an environment where all people are afforded the freedom to pursue their passions without regard to race, color, religion, national or ethnic origin, gender (including pregnancy), sexual orientation or expression, age, disability or veteran status or any other characteristics protected by law.