Senior Compliance Manager

Overview

This Senior Compliance Manager role serves as a legal and compliance leader responsible for overseeing enterprise-wide compliance, auditing, monitoring, and contracting activities within a biotechnology and life sciences environment. The position provides practical legal guidance to executive leadership while driving implementation and ongoing effectiveness of the organization’s compliance program, including support for development, manufacturing, and commercialization of innovative healthcare products.

Responsibilities

• Lead the design, implementation, and ongoing execution of the compliance program to ensure alignment with applicable laws, regulations, and industry standards in pharmaceuticals, medical devices, and life sciences.
• Serve as a trusted advisor to executive leadership, providing clear, practical guidance on compliance, regulatory, and legal matters impacting business operations.
• Oversee auditing and monitoring activities to assess compliance with FDA regulations, healthcare laws, and internal policies; implement corrective action plans as needed.
• Manage and conduct internal audits and monitoring programs, including planning, execution, documentation, and reporting of findings to relevant stakeholders.
• Lead internal investigations into potential compliance issues, ensuring thorough documentation, appropriate escalation, and timely resolution.
• Draft, review, and negotiate contracts and related legal documents to support business operations while managing legal and compliance risk.
• Develop, implement, and update compliance policies and procedures based on ongoing risk assessments and evolving regulatory requirements.
• Apply the OIG 7 Elements of an Effective Compliance Program to strengthen and continuously improve the compliance framework.
• Ensure compliance with key healthcare laws and regulations, including FDA requirements, Anti-Kickback Statute, False Claims Act, HIPAA, and relevant OIG guidance.
• Incorporate industry codes such as the AdvaMed Code and PhRMA Code into company policies, procedures, and business practices.
• Design, deliver, and oversee role-based compliance training for internal stakeholders and external distributors, tailored to specific functions and risk areas.
• Promote a culture of compliance, ethics, and accountability through communication, education, and consistent application of policies.
• Maintain strict confidentiality and handle sensitive matters with professionalism, sound judgment, and discretion.
• Collaborate with cross-functional teams (legal, regulatory, quality, commercial, and operations) to ensure business initiatives align with compliance requirements.
• Monitor changes in laws, regulations, and industry guidance related to pharmaceuticals, medical devices, and life sciences and advise on necessary compliance program updates.

Essential Skills / Qualifications

• At least 7 years of combined legal and compliance experience in the pharmaceuticals, medical device, or life sciences industries.
• Strong working knowledge of FDA regulations relevant to pharmaceuticals, medical devices, and related healthcare products.
• In-depth understanding of healthcare compliance frameworks, including OIG guidance, the Anti-Kickback Statute, False Claims Act, and HIPAA.
• Proven experience designing and managing audits and monitoring programs within a regulated healthcare or life sciences environment.
• Demonstrated experience conducting internal investigations related to compliance or legal matters.
• Significant experience drafting, reviewing, and negotiating contracts in the pharmaceutical, medical device, or life sciences sectors.
• Ability to exercise sound judgment and maintain confidentiality while handling sensitive and complex matters.
• Familiarity with compliance program effectiveness frameworks and industry codes, including the AdvaMed Code and PhRMA Code.
• Working knowledge of the OIG 7 Elements of an Effective Compliance Program and ability to apply them in practice.
• Experience delivering compliance training to internal stakeholders and distributors, including development of role-based training content.
• Background in pharmaceuticals or medical devices, with practical exposure to compliance and legal issues specific to these industries.
• Strong diligence and attention to detail in legal, compliance, and auditing activities.
• Ability to interpret and apply legal and regulatory requirements to real-world business operations in a clear, practical manner.

Additional Skills & Qualifications (Preferred)

• Experience working within the broader healthcare, medical, or pharmaceutical industry, including collaboration with healthcare providers and distributors.
• Familiarity with medical device and pharmaceutical compliance considerations, including promotional practices and interactions with healthcare professionals.
• Strong communication skills, including ability to explain complex legal and regulatory concepts to non-legal stakeholders.
• Proven ability to develop, amend, and implement policies and procedures based on ongoing risk assessments and emerging regulatory trends.
• Experience creating and tailoring role-based compliance training programs for diverse audiences across the organization and distribution network.
• Demonstrated ability to manage multiple priorities and projects in a fast-paced, innovation-driven environment.
• Professionalism, integrity, and commitment to fostering an ethical and compliant organizational culture.

Compensation & Benefits

• Pay range: $180,000.00 - $220,000.00/yr.
• Individual compensation offered within this range will depend on qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other job-related factors.

Benefits include:

• Comprehensive medical and health insurance plans for employees and their families
• Retirement benefits such as a 401(k) plan
• Generous paid time off (PTO)
• Life insurance coverage
• Healthcare coverage and wellness programs
• Competitive salaries and performance components
• Flexible schedules and work-life balance initiatives

Location / Work Setup

• Permanent position based out of Mesa, AZ.
• Fully remote.
• Monday through Friday schedule.
• Candidates located on the East Coast will work flexible hours aligned with West Coast business operations.

Application / Closing Date

• Anticipated to close on Oct 19, 2026.