Job Description

About the Role

Were supporting a purpose driven pharmaceutical company focused on bringing safe, effective, and non addictive pain relief solutions to market. Operating through a virtual manufacturing model, we collaborate with trusted external partners to develop, produce, and distribute our therapies. As we grow, were seeking a highly skilled and hands on quality leader to build and drive our Quality and Compliance function.

What You'll Be Doing

The Head of Quality & Compliance will serve as the companys quality lead, owning both the strategy and day to day execution of the Quality Management System and all regulatory responsibilities. This individual contributor role offers high visibility, autonomy, and direct impact ideal for a leader whos as comfortable writing an SOP as they are shaping regulatory strategy.

Key Responsibilities

Quality Strategy & Execution

• Partner with the CEO to shape and implement a forward-looking, risk-based quality strategy.
• Own and evolve the companys QMSauthoring SOPs, maintaining documentation, and leading ongoing improvements.
• Personally manage deviations, CAPAs, risk assessments, product releases, and document control processes.
• Review and approve quality-critical records, including batch documentation and change controls.
• Foster a culture where quality and compliance serve as enablers of innovation and growth.

Regulatory & Compliance

• Serve as the primary point of contact for FDA, state Boards of Pharmacy, and other regulatory bodies.
• Lead all regulatory inspections, audits, and investigations, ensuring clear communication and prompt resolution.
• Own and manage the companys Compliance Program in alignment with OIG guidance and applicable laws.
• Ensure compliance with the False Claims Act, pricing transparency laws, MDRP, 340B, and related programs.
• Partner with Finance and Commercial to support compliant pricing, rebate, and contracting strategies.
• Stay up to date on emerging regulatory developments and proactively adapt policies and processes.

External Partner Oversight

• Oversee quality performance across all CMOs, CPOs, 3PLs, and other third-party partners.
• Establish, manage, and enforce robust Quality Agreements.
• Audit and verify all partner data and recordstrust, but always verify.

Cross-Functional Collaboration

• Align quality initiatives with operational and business goals.
• Lead or support state licensing, product registrations, and regulatory submissions.

Required:

• 8+ years of experience in pharmaceutical quality, including GMP, QMS ownership, and regulatory interface.
• 2-3 years of direct wholesale transactional experience
• Proven ability to work independently in a hybrid strategic/tactical role.
• Experience managing external manufacturing and distribution partners.
• Demonstrated attention to detail, accountability, and professional maturity.
• Bachelors degree in a life sciences discipline.
• Direct experience with regulatory inspections at the federal and state levels.

Preferred:

• Experience in a virtual manufacturing model or early-stage company.
• Advanced degree or certifications (e.g., RAC, ASQ, Six Sigma).
• Familiarity with NDA/ANDA filings.
• Active Designated Representative certifications in CA and FL.
• Experience with NABP (formerly VAWD) accreditation.
• Compliance program leadership in alignment with OIG guidance.
• Knowledge of promotional review processes, third-party oversight, and multi-state licensing risks.

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