Senior Manager – Healthcare Compliance

Orca

Compliance professional supporting in-house healthcare compliance function at Orca Bio. Leading policy development, training, and compliance review with cross-functional collaboration.

Posted 5/16/2026full-timeRemote • California • 🇺🇸 United StatesSenior💰 $150,000 - $200,000 per yearWebsite

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

Bachelor’s degree in life sciences, law, business, or a related field; advanced degree (e.g., JD, MBA) preferred.
Minimum of 72 months 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.

Benefits

Comp & perks

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

ATS Keywords

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Hard Skills & Tools

compliance program developmentpolicy developmentcompliance trainingcompliance auditsrisk assessmentswhistleblower hotline managementregulatory complianceFDA regulationsGxP standardshealthcare compliance

Soft Skills

analytical skillsproblem-solving skillsbusiness judgmentcollaborative approachindependent task managementcommunication skillsleadershipinterpersonal skillsorganizational skillscross-functional teamwork

Certifications

Bachelor’s degreeadvanced degree (JD, MBA)