Head of Quality & Compliance

Head of Quality & Compliance

Location: Reno NV (On-Site)Reports To: CEOType: Full-Time Exempt

About Terrain Pharmaceuticals

Terrain Pharmaceuticals is a mission-driven company focused on delivering non-addictive pain relief products. Operating under a virtual manufacturing model we collaborate with trusted CMOs CPOs and 3PLs to develop and distribute safe effective pharmaceutical solutions. We are seeking a Head of Quality who brings deep regulatory experience precision and the ability to work flexibly within a high-accountability low-ego environment.

Position Summary

The Head of Quality leads Terrains Quality function; serving as both the strategic owner and the hands-on executor of our Quality Management System (QMS) regulatory compliance and external partner oversight. This role is highly autonomous and critical to our success especially given our lean organizational structure and reliance on external manufacturing warehousing packaging and other key are no direct reports currently; this role is ideal for a skilled quality leader who thrives on doing the work not just directing it.

Who You Are

We are looking for someone who thrives in a lean dynamic setting where your ability to execute directly matters as much as your strategic insight. You bring:

• Competence and precision You deliver high-quality work consistently with no tolerance for careless errors.
• Humble confidence Youre an expert but you operate with low ego and welcome input from others.
• Verification mindset You assume nothing. You validate claims confirm data and ensure all facts are supported.
• Flexible thinking You understand regulatory constraints deeply and can work creatively within them to find compliant efficient solutions.
• Execution-first attitude You roll up your sleeves to get things done whether its drafting an SOP or managing a CAPA.

Key Responsibilities

Execution & Quality Leadership

• Partner with the CEO in shaping and operationalizing a forward-thinking regulatory approach that enables business growth. Approach compliance challenges with a mindset of not if but how ensuring that regulatory pathways are navigated not as constraints but as avenues for innovation and execution. Bring both structure and creativity to bear in identifying compliant risk-informed solutions that advance company objectives. Champion a culture where quality and compliance are accelerators not obstacles..
• Lead Companys QMS: author guide implement and maintain SOPs forms and records.
• Review and approve quality-critical documentation including batch records change controls and deviations.
• Personally manage NCRs CAPAs risk assessments product release and document control.

Regulatory & Compliance

• Serve as primary point of contact with FDA state Boards of Pharmacy and other regulatory authorities for all quality-related and compliance matters.
• Oversee and coordinate all interactions with regulatory bodies and trading partners during inspections audits and investigations ensuring proactive readiness clear communication and timely response to findings.
• Lead the development implementation and maintenance of Companys Compliance Program in alignment with OIG guidelines ensuring adherence to all applicable federal and state regulatory requirements.
• Monitor and enforce compliance with False Claims Act provisions and all relevant healthcare fraud and abuse laws applicable to pharmaceutical manufacturers.
• Ensure compliance oversight across all operations involving CMOs CPOs 3PLs and promotional activities including documentation and risk assessment practices.
• Prepare Company for regulatory inspections audits and investigations ensuring timely resolution of any findings or compliance issues.
• Maintain a system for internal compliance audits and partner evaluations; manage findings through CAPAs.
• Serve as the liaison with legal counsel for matters involving regulatory interpretations and enforcement risks.
• Oversee Companys compliance with pharmaceutical pricing and reporting regulations including Medicaid Drug Rebate Program (MDRP) 340B Drug Pricing Program and other state and federal pricing transparency laws.
• Collaborate with Finance and Commercial functions to ensure appropriate capture validation and reporting of pricing data.
• Maintain up-to-date knowledge of changes in pricing compliance laws and guidance from CMS OIG and other regulatory bodies and adjust Companys policies and controls accordingly.
• Support the design and audit of compliant pricing strategies rebate programs and commercial contracts to minimize legal and financial risk.

External Partner Oversight

• Oversee the quality performance of multiple CMOs CPOs and 3PLs.
• Implement maintain support and enforce robust Quality Agreements.
• Verify partner data audit reports and compliance records; never assume always confirm.

Cross-Functional Collaboration

• Partner with Operations team to align quality strategy with business needs.
• Lead product registration state licensing and other regulatory submissions as the quality lead.

Qualifications

Required:

• 8 years of pharmaceutical quality experience with a strong working knowledge of GMP QMS and regulatory expectations.
• Demonstrated ability to function independently in a hybrid strategy/execution role.
• Experience managing external partners (CMOs CPOs 3PLs).
• Track record of executing with attention to detail ownership and professional humility.
• Bachelors degree or greater in a life sciences discipline.
• Experience supporting FDA and State Board inspections directly

Preferred:

• Prior experience in a virtual manufacturing or startup environment.
• Advanced degree or relevant certification (e.g. RAC ASQ Six Sigma).
• Experience in successfully navigating complex ambiguous or nascent regulatory categories.
• Experience preparing and filing new drug applications and abbreviated new drug applications.
• Active CA and FL Designated Representative certification.
• NABP (formerly VAWD)-accreditation experience.
• Experience in implementing or managing a Compliance Program in accordance with HHS OIG guidelines.
• Familiarity with compliance risks in virtual manufacturing including third-party oversight promotional review processes and interstate licensing.

Compensation & Benefits

• Base Pay: $150000 - $200000 (depending on experience)
• Comprehensive medical dental and vision benefits
• PTO 401(k) with match holidays and relocation support (role is based in Reno NV)

Location

• This position is 100% on-site in Reno NV
• Travel to partner sites and regulatory meetings required. Estimated travel 5-10 days per quarter.