Associate Director, GCP/GLP/GVP QA

• 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 help 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 assess consistency and compliance with regulatory requirements and internal standards.
• Manage Rhythm’s QMS for Clinical QA activities, including development and management of controlled documents and training matrices, audits, CAPAs/deviations and management and approval of related documentation.
• Develop and deliver GCP training for Rhythm including implementation of continuous training activities such as webinars, lunch and learns, GCP/compliance updates.
• Lead or assist with GCP health authority inspections, assist clinical teams in preparation for inspections, and provide GCP compliance technical support during inspections of vendors, clinical investigator sites and Rhythm. Facilitate appropriate and 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 (INDs) applications, and New Drug Applications (NDAs). 
• Collaborate cross-functionally and with external parties topromote a high level of quality and consistency across clinical programs and to identify and mitigate GCP quality and compliance issues.
• Collaborate cross-functionally and with external parties to
• 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.

• Bachelor's Degree in a clinical/scientific field, is 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 and/or awareness of ICH GCP, and applicable global regulations and guidance for clinical development. Knowledge in GLP and GVP regulations is a plus.
• Excellent communication, writing, and presentation skills for effectively interfacing with internal and external stakeholders. 
• Strong judgement, 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 on aligned tactics. 
• Ability to foster effective relationships with vendors, investigators, and colleagues.
• Willingness to travel up to 25% to various meetings and/or audits, including overnight trips. Some international travel may be required. 

• We are committed to advancing scientific understanding to improve patients’ lives
• We are inspired to tackle tough challenges and have the courage to ask bold questions
• We are eager to learn and adapt
• We believe collaboration and ownership are foundational for our success
• We value the unique contribution each individual brings to furthering our mission

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