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Role Description

Orca Bio is building its first in-house healthcare compliance function and is seeking a motivated and adaptable compliance professional to support the development and execution of that program. Reporting to the SVP/Head of Legal, the Senior Manager or Associate Director, Healthcare Compliance will work cross-functionally to lead key elements of a pre-commercial compliance program—including:

• Policy and SOP development
• Transparency and aggregate spend reporting
• Training
• Commercial and promotional compliance review

The role will also support future field engagements following potential product approval. Travel: ~25%. Remote applicants accepted, with preference for those near Orca Bio HQ.

Qualifications

• Bachelor’s degree in life sciences, law, business, or a related field; advanced degree (e.g., JD, MBA) preferred.
• Minimum of 6 years of experience in compliance, regulatory affairs, or a related field within the pharmaceutical or biotech industry.
• Strong knowledge of FDA regulations, GxP standards, and other relevant compliance frameworks.
• Proven ability to interpret and apply complex regulations and guidelines to business practices.
• Excellent analytical, problem-solving skills.
• Well-rounded, experienced compliance expert with excellent business judgment concerning overall healthcare compliance and risk management.
• Ability to work effectively in cross-functional teams with a collaborative and hands-on approach.
• Ability to manage multiple tasks independently and simultaneously.

Requirements

• Assist in the ongoing development, implementation, and maintenance of the Company’s compliance program that aligns with industry standards and regulatory requirements.
• Develop policies and procedures that provide appropriate guidance and instruction to Company employees.
• Lead the development and delivery of compliance training programs for employees at all levels.
• Conduct regular compliance audits, monitoring and risk assessments to identify potential areas of compliance vulnerability and risk.
• Assist in the completion of activities related to federal and relevant state transparency-driven compliance requirements.
• Manage the Company’s whistleblower hotline.
• Collaborate with legal, regulatory, and operational teams to provide compliance guidance and support for new initiatives and projects.
• Investigate compliance-related issues and coordinate with relevant stakeholders to ensure appropriate corrective actions are taken.
• Stay current with industry trends, regulatory changes, and best practices in compliance.
• Engage in such other activities as directed by the Senior Vice President, Legal.

Benefits

• $150,000 - $200,000 a year
• Eligibility to receive pre-IPO equity
• Competitive medical, dental, and vision benefits
• PTO
• 401(k) plan
• Life and accidental death and disability coverage
• Parental leave benefits
• Subsidized daily lunches and snacks at on-site locations

Company Description

We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.

• We live by our core values of passion, courage, and integrity.
• Excellence in our work means the chance to unlock a better quality of life for our patients.
• We innovate on a path that hasn’t been paved, embracing an entrepreneurial spirit.
• We maintain a start-up culture of camaraderie and leadership by example.
• We’re proud to be an equal opportunity employer, recognizing that celebrating our differences creates stronger solutions.