Head, GCP/GLP Quality Assurance

Rhythm Pharmaceuticals • Boston, MA

2d • $210,000 - $300,000 • Hybrid

About The Position

The Head, GCP/GLP Quality Assurance provides strategic leadership and direction to ensure Rhythm’s clinical trials are conducted with integrity, quality, and in full compliance with GCP and applicable regulations. The primary responsibility of this role is to guide and advise the clinical organization on key quality and compliance topics (e.g., protocol deviations, quality risk management, CAPA expectations) and to serve as a subject‑matter resource for GCP interpretation and application when consulted. The Head, GCP/GLP Quality Assurance works in partnership with cross‑functional leaders to ensure the right level of oversight is applied to Rhythm’s clinical programs and that global quality expectations are understood, practical, and consistently implemented by influencing through guidance, advice, and risk‑based recommendations rather than directive instruction. This role also includes leadership and people management responsibilities for an existing GCP QA team and thoughtfully growing the team as business needs evolve. This role reports into the SVP, Head of Global Regulatory Affairs.

Requirements

• Bachelor’s degree in a scientific or healthcare discipline (e.g., life sciences, pharmacy, nursing) required; advanced degree (e.g., MS, PharmD, PhD, MPH) preferred.
• Extensive experience (12+ years) in clinical research, clinical quality assurance, or related GCP‑focused roles within the biopharmaceutical, biotechnology, or CRO industry.
• Significant leadership experience (5+ years) managing GCP QA and/or clinical quality teams, including responsibility for hiring, coaching, performance management, and developing talent.
• Deep understanding of ICH‑GCP, FDA, EMA, and other global regulatory requirements and guidance relevant to clinical research, including practical experience applying these requirements in a sponsor setting.
• Demonstrated experience providing consultative quality and compliance guidance to cross‑functional clinical teams (e.g., on protocol deviations, inspections, CAPAs, risk‑based oversight) in a collaborative, non‑policing manner.
• Proven track record of effective collaboration with Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, Pharmacovigilance, and other key stakeholders on quality‑related topics.
• Experience preparing for and supporting GCP regulatory inspections and/or sponsor/CRO audits, including development and implementation of meaningful CAPAs and follow‑up activities.
• Strong background in developing, implementing, and maintaining clinical quality systems and documentation (e.g., SOPs, quality standards, guidance documents), ideally in a growing or evolving organization.
• Demonstrated ability to apply risk‑based principles to clinical quality oversight, including quality risk assessments, issue management, and escalation pathways.
• Excellent communication and interpersonal skills, with the ability to explain complex GCP/quality concepts in clear, practical terms and to influence without authority across levels and functions.
• Proven ability to operate as a strategic, hands‑on leader who can both set direction and engage in detailed review and problem‑solving when needed.
• Strong analytical and critical‑thinking skills, including the ability to interpret quality data/metrics and identify trends, risks, and improvement opportunities.
• High level of integrity, sound judgment, and commitment to patient safety, data integrity, and ethical clinical trial conduct.
• Ability to thrive in a fast‑paced, matrixed, and evolving environment, balancing multiple priorities and adapting to changing business needs.

Nice To Haves

• Prior experience in rare disease, metabolic disorders, or similarly complex therapeutic areas is a plus but not required.
• Prior experience and/or knowledge of GLP Quality Assurance is also a plus.

Responsibilities

• Serve as the primary GCP quality resource and advisor to the clinical teams, providing expert, consultative guidance on protocol deviations (assessment, classification, trending, and escalation), non‑compliance, and other key QA topics to support sound, risk‑based decision‑making, while respecting functional ownership and accountability.
• Provide non‑directive, advisory GCP and quality guidance across Rhythm’s clinical portfolio, ensuring that study teams, functional partners, and senior leaders understand regulatory expectations and apply an appropriate level of oversight to protect subject safety, rights, and data integrity.
• In partnership with the clinical team, advise on and, where appropriate, review oversight strategies for CROs, investigator sites, and other vendors to support quality, reliability, and adherence to regulations, GCP, and internal requirements, while enabling functions to retain operational decision‑making authority.
• Lead and/or oversee the development, interpretation, and implementation of clinical quality standards and procedures (e.g., SOPs, guidance documents, quality manuals) that enable compliant, efficient, and pragmatic conduct of clinical trials, crafted through cross‑functional input and alignment rather than unilateral direction.
• Develop and maintain risk‑based approaches to clinical quality oversight, including providing guidance on quality risk assessments, risk mitigation plans, and appropriate documentation of rationales and decisions, in collaboration with functional stakeholders.
• Provide leadership and coordination for GCP inspection and audit readiness, including coaching study teams on expectations, contributing to responses, and collaborating on corrective/preventive actions that are appropriate, feasible, and effectively implemented, without assuming day‑to‑day operational control.
• Serve as a key point of contact for questions related to GCP interpretation, inspection trends, and regulatory expectations, translating external requirements into clear, practical advice and options for internal stakeholders, and enabling informed decision‑making.
• Guide the development and delivery of targeted training and awareness initiatives on GCP and clinical quality topics—such as protocol deviations, issue escalation, documentation practices, and quality risk management—designed and delivered in close collaboration with cross‑functional partners.
• Establish and monitor appropriate quality oversight indicators (e.g., deviation trends, issue/CAPA themes, inspection/audit outcomes) and advise leadership and study teams on emerging risks, patterns, and opportunities for improvement in clinical trial conduct, using data to inform collaborative problem‑solving rather than enforcement.
• Foster a culture of quality, integrity, and open dialogue by encouraging early consultation with QA, promoting transparent issue escalation, and supporting continuous learning from deviations, audits, inspections, and quality issues across functions.
• Collaborate closely with cross‑functional teams, including clinical operations, biostatistics, data management, regulatory affairs, pharmacovigilance, and others, to ensure that clinical quality expectations are jointly defined, aligned, and integrated across processes and systems.
• Support Translational Research and Development through auditing and oversight of GLP vendors.
• Lead, develop, and mentor the clinical quality assurance team, role‑modeling a collaborative, solution‑oriented, non‑policing approach to quality; provide regular coaching, feedback, and development planning to build deep GCP expertise and strong consultative skills.
• Define and regularly reassess the organizational design, capabilities, and resourcing needs of the GCP QA function; plan for and execute the thoughtful growth of the team in line with portfolio expansion and business priorities, including recruiting, onboarding, and integrating new team members.
• Set clear expectations, goals, and performance measures for team members; conduct performance reviews and support career development, succession planning, and retention of key talent within the GCP QA organization.

Benefits

• A discretionary annual bonus may be available based on individual and company performance.
• This role may be eligible for benefits and other compensation such as restricted stock units.

What This Job Offers

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