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SalaryAbout Akoya Biosciences:
As The Spatial Biology Company®, Akoya Biosciences’ mission is to bring context to the world of biology and human health through the power of spatial phenotyping. The company offers comprehensive single-cell imaging solutions that allow researchers to phenotype cells with spatial context and visualize how they organize and interact to influence disease progression and response to therapy. Akoya offers a full continuum of spatial phenotyping solutions to serve the diverse needs of researchers across discovery, translational and clinical research: PhenoCode™ Panels and PhenoCycler®, PhenoImager® Fusion, and PhenoImager HT Instruments.
Job Description Summary:
The Manager of Quality Assurance and Regulatory Affairs, Laboratory Services provides CLIA compliance in a clinical lab setting supporting clinical testing services and projects. This individual will foster collaborations between ABS Operations, R&D, Manufacturing, and Akoya’s IVD Program Management Team to ensure the highest possible quality outcomes, while focusing on the implementation and daily maintenance of a Quality Management System (QMS) in a CLIA, GLP and GCP setting.
The Manager will navigate the regulatory landscape in a CLIA lab setting, taking a lead role in compliance audits with federal and local regulatory agencies. The manager will help develop and implement effective, robust QMS processes and methods in alignment with regulatory, CLIA and CAP requirements, while utilizing quality-based approach to continually improve processes and drive efficiency. The Manager will oversee the quality management system of Applied Biopharma Services (ABS), as well as potential IVD companion diagnostic partners and build and manage an infrastructure that meets applicable regulatory standards, professional guidelines, and customer requirements for ensuring and maintaining quality and continually improving Laboratory Services. In addition, the Manager will lead the process and provide hands-on assistance to lab services personnel for setting standards for reagents, assay validation and instrument qualification in a regulated environment. This position is hands-on in a fast-paced environment requiring a skill set able to lead, as well as roll up the sleeves and make a difference.
Duties and Responsibilities:
- Directly manage QA Lab Support personnel.
- Lead the Quality Assurance processes for Clinical Research Services (CRS).
- Help implement and maintain quality/regulatory aspects of CLIA, GLP and ICH-GCP.
- Ensure CRS team is up to date on their relevant regulatory training.
- Work closely with the Lab Director and other staff members to align on CRS objectives.
- Interact with regulatory agencies and external vendors and assist with audits.
- Ensure that all standards for reagent and assay validation are met.
- Assist with writing and maintaining quality and Regulatory SOPs.
- Maintain appropriate regulatory documentation and ensure audit-readiness.
- Communicate deviations to appropriate authorities and assist with corrective action.
- Oversees the implementation of all regulatory compliance requirements.
- Validate lab system software and assess needs for revalidation.
- Ensure sample tracking and workflows in LIMS, monitoring of lab instruments.
- Implement measures to monitor the effectiveness of quality systems.
- Ability to work on site a minimum of two days/week, and more as needed by the organization.
- Perform other duties as assigned.
Skills & Requirements
- Bachelor’s degree in healthcare or related field, or the equivalent combination of education, experience and/or training
- 5-7 years of Quality Assurance or regulatory certification experience in a CLIA and/or GCP / GLP laboratory environment.
- Minimum of two years of Lab QA management experience.
- Experience with obtaining CLIA certification and maintaining CLIA standards.
- Understanding of ICH-GCP (21 CRF Parts 11, 50, 56, 58, 312 and 314), and applying such regulations within a laboratory setting.
- Direct experience supporting and/or leading certification and client audits.
- Experience with LIMS (laboratory information management system), proficiency testing, validation processes and reports.
- Excellent organizational and communication skills.
- Experience in IHC and quantitative pathology is a plus.
- Understanding of ISO13485 and FDA QSR 820 is a plus.
- Certifications in Quality such as ISO, Auditor, CCRA or ACRP is optional but preferred.
- Previous experience working with companion diagnostics is a plus.
The hiring range for this position is $130,000 - $150,000 per year, which may factor in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate’s geographic region, job-related knowledge, skills, and experience among other factors. Our full-time regular positions also include an annual performance-based bonus (or a sales incentive plan) and long-term incentive units (equity) provided as part of our compensation package, in addition to a full range of medical, financial, and/or other benefits, dependent on the level and position offered.
Akoya’s excellent benefits program includes a selection of Medical and Dental plans, and Life, AD&D and Short-Term Disability insurance, Tuition Reimbursement, 401(k) with immediate Company match vesting, Company paid holidays and more!
Akoya values bringing together individuals with diverse backgrounds. We are proud to be an Equal Opportunity/Affirmative Action Employer. We do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
