Associate Director, GCP/GLP/GVP QA

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

Opportunity Overview

As the Associate Director, GCP/GLP/GVP QA, you will oversee GCP activities, ensure compliance and quality execution of clinical studies. You will assist in the development and management of GCP quality processes and procedures to support and maintain GCP compliance within Rhythm. In this role you will manage cross‑functional relationships with internal and external stakeholders and act as a QA representative to clinical teams. You will report to the Executive Director, Head of GCP/GVP/GLP QA.

Responsibilities and Duties

• Provide GCP oversight, collaborate cross‑functionally and provide guidance to the GCP functional groups that support clinical studies.
• Oversee the vendor management program, create and manage study‑specific Clinical Audit Plans. Interact with contract auditors, as needed, to facilitate the audit process with internal and external stakeholders.
• Proactively identify compliance issues/risks and recommend mitigations.
• Draft, review, revise, or provide input to SOPs to ensure consistency and compliance with regulatory requirements and internal standards.
• Manage Rhythm’s QMS for Clinical QA activities, including development and management of controlled documents, training matrices, audits, CAPAs/deviations and related documentation approval.
• Develop and deliver GCP training for Rhythm, including implementation of continuous training activities such as webinars, lunch and learns, and GCP/compliance updates.
• Lead or assist with GCP health‑authority inspections; assist clinical teams in preparation and provide technical support during inspections of vendors, clinical investigator sites, and Rhythm. Facilitate timely inspection responses and follow‑up actions.
• Review key safety, clinical and regulatory documents such as protocols, amendments, Informed Consent Forms (ICFs), Clinical Study Reports (CSRs), Development Safety Update Reports (DSURs), Investigator’s Brochure (IBs), Investigational New Drug (IND) applications and New Drug Applications (NDAs).
• Collaborate cross‑functionally and with external parties to promote a high level of quality and consistency across clinical programs and identify and mitigate GCP quality and compliance issues.
• Escalate systemic and/or critical problems and recommend appropriate solutions for immediate and long‑term resolution.
• Train and mentor employees on global GCP regulations and guidance as needed.

Qualifications and Skills

• Bachelor’s Degree in a clinical/scientific field preferred, with 8+ years of relevant industry experience.
• 5+ years of GCP‑related Quality Assurance or relevant clinical trial experience.
• Experience supporting Regulatory Authority GCP inspections.
• Extensive knowledge of ICH GCP and applicable global regulations and guidance for clinical development. Knowledge of GLP and GVP regulations is a plus.
• Excellent communication, writing and presentation skills for interfacing with internal and external stakeholders.
• Strong judgment, project management and decision‑making skills; able to manage multiple projects and demanding timelines.
• Demonstrated ability to work independently and in a team environment.
• Ability to assess complex issues, propose viable solutions, and follow through to resolution.
• Demonstrated ability to organize cross‑functional teams and execute aligned tactics.
• Ability to foster effective relationships with vendors, investigators and colleagues.
• Willingness to travel up to 25% for meetings and/or audits, including overnight trips; some international travel may be required.

Employment Details

This role is based out of our corporate office in Boston, Massachusetts. Rhythm operates in a hybrid‑work model; candidates must be willing and able to be in the Boston office in coordination with departmental and business needs.

The expected salary range for this position is $160,000 - $240,000. Actual pay will be determined based on experience, level, qualifications, geographic location and other job‑related factors permitted by law. A discretionary annual bonus may be available based on individual and company performance. This role may also be eligible for benefits and other compensation such as restricted stock units.

Rhythm is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.