QA Leader - GCP/GLP/GVP (Associate Director)

Rhythm Pharmaceuticals, Inc; Boston (MA); Hybrid; USD 160,000 - 240,000; Full time

Job summary

Rhythm Pharmaceuticals, Inc is seeking an Associate Director, GCP/GLP/GVP QA to oversee GCP activities, ensure compliance and quality execution of clinical studies. You will develop and manage GCP quality processes and act as QA representative to clinical teams in Boston, with a hybrid work model.

Responsibilities include oversight of vendor audits, development of audit plans, drafting SOPs, managing QMS, delivering GCP training, supporting inspections, and reviewing protocols, DSURs, IBs, INDs

Qualifications

• 8+ years of relevant industry experience in clinical QA.
• 5+ years of GCP-related QA or clinical trial experience.
• Experience supporting regulatory authority GCP inspections.
• Knowledge of ICH GCP and global regulations; GLP/GVP a plus.
• Excellent communication, writing and presentation skills.
• Strong judgment, project management and ability to manage multiple projects.

Responsibilities

• Provide GCP oversight and guidance to cross-functional teams.
• Oversee vendor management and study-specific audit plans.
• Identify compliance risks and recommend mitigations.
• Draft and review SOPs to ensure regulatory compliance.
• Manage QMS for Clinical QA activities, including documents, training, audits, CAPAs.
• Develop and deliver GCP training and updates.
• Lead or assist with GCP inspections and coordinate responses.
• Review key safety, clinical and regulatory documents (protocols, CSRs, DSURs, IBs, INDs/NDAs).
• Collaborate with internal and external parties to ensure quality across programs.
• Escalate problems and propose solutions for long-term resolution.
• Train and mentor employees on global GCP regulations.

Skills

GCP QA experience

Regulatory inspections experience

Communication skills

Project management

Team collaboration

Education

Bachelor’s Degree in clinical/scientific field

Job description

Rhythm Pharmaceuticals, Inc is seeking an Associate Director, GCP/GLP/GVP QA to oversee GCP activities, ensure compliance and quality execution of clinical studies. You will develop and manage GCP quality processes and act as QA representative to clinical teams in Boston, with a hybrid work model.

Responsibilities include oversight of vendor audits, development of audit plans, drafting SOPs, managing QMS, delivering GCP training, supporting inspections, and reviewing protocols, DSURs, IBs, INDs