General Counsel

Description

The General Counsel serves as the chief legal advisor to the organization, providing strategic legal guidance to executive leadership and ensuring the company’s operations comply with applicable laws, regulations, and ethical standards. This role oversees all legal matters related to plasma collection, donor rights, regulatory compliance, employment law, corporate governance, risk management, and contracts. The General Counsel plays a critical role in safeguarding the company’s reputation and supporting its growth objectives in a highly regulated industry.

Department: Legal

Location: Austin, TX

• 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.

• 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.