The Senior Manager, QA - Commercial GMP oversees Quality Assurance for drug manufacturing, ensuring GMP compliance and leading quality initiatives. They support audits, product lifecycle management, and continuous improvement, while mentoring QA teams and integrating digital tools into processes.

The Manager of Regulatory Affairs will develop regulatory strategies and support submissions for CMC and clinical activities, ensuring compliance and collaboration across teams.

The Pharmacovigilance Operations Manager will oversee pharmacovigilance activities, ensuring compliance and data quality, manage vendor oversight, and support clinical-to-commercial transitions.

Lead design and implementation of the commercial data and systems foundation for launch and growth. Own Salesforce-led commercial systems, integrations, data warehouse, MDM, analytics enablement, governance, and scalable delivery to support commercial operations, reporting, and compliance.

Lead analytical development and quality control strategy to support late-stage clinical development, BLA submissions, and commercial readiness. Oversee method development/validation, QC operations, vendor management, regulatory interactions, and build a scalable AD/QC organization.

Lead national payor strategy and relationships to secure coverage, reimbursement, and formulary placement for a biotech product launch. Develop account plans, negotiate pricing/contracting, coordinate cross-functional resources, and communicate market access insights to internal stakeholders.

Lead analytical method development, validation, transfer, and troubleshooting for late-stage/commercial live viral biologics. Mentor staff, oversee contract labs, design studies (DOE/OFAT), perform data/statistical analyses, ensure cGMP compliance, and support regulatory filings and investigations.