Director, Clinical Biomarker Lab QC

The Role

We are seeking a highly motivated, collaborative, and innovative Director of GLP/GcLP Compliance within the Clinical Assay, Supplies and Logistics (CASL) team who will provide strategic direction and coordination of compliance assessment monitoring of Clinical Biomarker and Bioanalytical Molecular Assay (BMA) laboratories and clinical testing activities to ensure compliance with internal processes, applicable GLP/GcLP regulations, and regulatory requirements.

Position Overview

The Director will lead, direct, coach, and develop a team of QC Compliance Professionals within Moderna’s state-of-the-art biomarker laboratories.  The incumbent will provide technical and managerial leadership by interfacing and collaborating with the bioanalytic team of Quality Control (QC) compliance professionals, and members of the laboratory functions performing PK, immunogenicity, and PD assays to ensure data integrity of the respective data workflows (e.g., data acquisition, bench analysis, data transfers, and final report writing) in a fast-paced, quick turnaround laboratory environment.  The team of QC compliance professionals will perform and evaluate quality control assessments on bioanalytical assays (e.g., multiplexing ligand binding assays, cell-based assays, Immunoassays, PCR assays, LC-MS assays), and PK (pharmacokinetics, pharmacodynamics), immunogenicity assays on primary and secondary endpoints (e.g., LNP and/or mRNA derived proteins). In addition, compliance professionals will perform and evaluate quality control assessments on and neutralizing antibodies (e.g., Virus Neutralization assays, and Flow Cytometry assays etc.) within the respective laboratories.

The Director will provide compliance and quality support and guidance related to laboratory activities and will play an integral role in the identification and management of compliance and quality issues as well as to support deviation management, CAPA management and investigations performed by QA.  The Director will be responsible for operational support and oversight of Good Document Management (GDP) practices, GLP/GcLP Compliance Training, and records management (including electronic and paper-based records) to ensure the laboratories are following applicable laboratory SOPs and protocols and current regulatory requirements.  The Director will work within the Norwood or Cambridge, MA, laboratory facilities and report to the Senior Director, Risk Management & GxP Compliance. 

Here’s What You’ll Do

• Oversee hiring, development, and building a cohesive, high performing team with a strong sense of mission, providing training, mentoring, and performance management.

• Build a team who can support QC review of data generated from bioanalytical, molecular and biomarker assays. Examples of assays are ligand binding assays, cell-based assays, LC-MS assays, molecular assays, virus neutralization assays, flow cytometry assays.

• Support the development of this new function; organize, prioritize, and manage all aspects of workload to meet business needs.

• Plan and oversee quality control checks, in addition to supporting compliance investigations for root cause analysis of critical and major deviations, compliance incidents, scientific fraud, and misconduct. 

• Coordinate with management and site operational leadership to ensure appropriate corrective and preventative actions are taken.

• Work on complex problems where analysis of situations or data requires in-depth evaluation of various factors, strong judgment is required in resolving problems and making recommendations.

• Identify innovative solutions to improve turn around QC time and to eliminate manual processes wherever feasible.  

• Collect and monitor quality and compliance metrics to provide regular status updates on quality and compliance and training metrics and highlight ongoing trends, signals, and actions taken.

• Support the development of Inspection Readiness processes across the clinical assay laboratories.

• Must be able to manage shifting parallel priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to team members.

Here’s What You’ll Need (Minimum Qualifications)

• Advanced degree required in relevant field (Pharmacy, Chemistry or Biology) with 7+ years of direct GLP/GcLP bioanalytical laboratory experience and compliance and/or quality assurance experience in the biopharma industry.

• Working knowledge of ligand binding assays, LC MS assays, PCR assays, FLOW assays and cell-based virus neutralization assays

• Working knowledge of quality systems and regulatory requirements for electronic record management (21 CRF Part 11/210/211) Knowledge of industry quality systems/standard