Senior Manager / Associate Director, Compliance

Orca Bio • Menlo Park, CA

1d • $150,000 - $200,000

About The Position

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.

Position Summary: 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, 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, and commercial and promotional compliance review. The role will also support future field engagements following potential product approval.

Requirements

• 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 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.

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.

Benefits

• You will also be eligible to receive pre-IPO equity, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits.
• Other perks include subsidized daily lunches and snacks at our on-site locations.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level