Orca Bio · 6 hours ago
Senior Manager / Associate Director, Compliance
Menlo Park, CA
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
$150K/yr - $200K/yr
6+ years expOrca Bio is a late-stage biotechnology company focused on redefining the transplant process through next-generation cell therapies. They are seeking a Senior Manager or Associate Director of Compliance to lead the development and execution of their healthcare compliance program, including policy development, training, and compliance audits.
Health CareMedicalPharmaceutical
Responsibilities
Assist in the ongoing development, implementation, and maintenance of the Company’s compliance program that aligns with industry standards and regulatory requirements, including federal, state, and international regulations, as appropriate
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
Qualification
Required
Bachelor's degree in life sciences, law, business, or a related field
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 who has played a key role on matters relating to the marketing and promotion of pharmaceutical products and possesses 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
Preferred
Advanced degree (e.g., JD, MBA)
Benefits
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 our on-site locations
Company
Orca Bio
Orca Bio is a clinical-stage cell therapy company dedicated to delivering curative medicine to patients.
201-500 employees
Funding
Current Stage
Late StageTotal Funding
$542MKey Investors
Lightspeed Venture PartnersSilicon Valley Bank
2026-01-09Series F· $250M
2026-01-09Debt Financing· $100M
2020-06-17Series D· $192M
Leadership Team
J
Jeroen Bekaert
Co-Founder and Chief Operating Officer
Recent News
2026-01-16
Company data provided by crunchbase