General Counsel

Description

Key Responsibilities

• Advise executive leadership and the board of directors on legal strategy, corporate governance, and risk management.
• Ensure organizational compliance with FDA, HIPAA, OSHA, cGMP, and other regulatory requirements relevant to the plasma and biopharmaceutical industry.
• Draft, review, and negotiate contracts, including vendor agreements, clinical partnerships, lease agreements, and donor-related documents.
• Oversee internal investigations and respond to regulatory audits or inquiries from agencies such as the FDA, OIG, or state health departments.
• Provide legal support for employment and labor matters, including workplace policies, disputes, and compliance with federal and state laws.
• Manage litigation, claims, and disputes, coordinating with external counsel as necessary.
• Support business development, mergers, and acquisitions, including due diligence and deal structuring.
• Lead the development and implementation of company-wide legal policies, training, and compliance programs.
• Serve as the key point of contact for external legal partners, regulators, and industry groups.
• Monitor emerging legal and regulatory trends that could impact the plasma industry and proactively advise leadership.
• Perform other duties as assigned.

Skills, Knowledge and Expertise

• Deep knowledge of regulatory frameworks including FDA regulations, HIPAA, cGMP, CLIA, and labor/employment law.
• Demonstrated ability to manage complex legal issues in a fast-paced, regulated environment.
• Exceptional judgment, communication, and leadership skills.
• Experience overseeing or managing legal teams and working cross-functionally with executive and operational stakeholders.
• Ability to manage external counsel and legal budgets effectively.

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