Auditing, Biotech and Pharmaceutical, Center For Drug Evaluation and Research (CDER), Cloud Computing, Corrective Action, Data Migration, FDA (Food and Drug Administration), Financial Management, Information Technology & Information Systems, Maintain Compliance, Management of Information Systems/Technology (MIS), Performance Analysis, Project Management Professional (PMP), Project/Program Management, Quality Management, Risk Management, Salesforce.com, Security Infrastructure, Software as a Service (SaaS), Vendor/Supplier Management
To acquire the advantage, Zolon PCS is seeking a Program Manager. This program will replace multiple decentralized and legacy quality management environments with a single, enterprise-wide platform that supports quality, compliance, training, audits, risk management, equipment management, supplier management, and corrective action processes across FDA Centers and Offices. The solution will support FDA organizations, including the Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), Human Food Program (HFP), Office of the Chief Scientist (OCS), Office of Inspections and Investigations (OII), and other FDA quality organizations.
Job Description:
Senior leader accountable for the successful execution of the FDA Cloud QMS BPA and task orders. Directs program governance, customer engagement, staffing, financial management, quality management, subcontractor coordination, risk mitigation, executive communications, and delivery performance. Oversees implementation of ComplianceQuest on Salesforce GovCloud, data migration, validation, training, deployment, and transition to O&M. Coordinates with FDA executives, Center stakeholders, COR/COTR, security teams, and platform vendors to ensure delivery within the one year implementation timeline while maintaining compliance, audit readiness, and service continuity.
Requirements:
15+ years managing large Federal IT programs;
5+ years leading enterprise SaaS, QMS, Salesforce, or ComplianceQuest implementations;
experience managing multi-vendor teams and executive stakeholders.
Bachelor's degree.
PMP preferred.
Master's degree desirable.
Clearance: Ability to obtain Public Trust tier 2
Location: White Oak, Maryland (Hybrid)