Description

Company Overview
Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases and provide meaningful support for healthcare providers and patients and their families. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together.

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 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 to promote 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.

Qualifications and Skills

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.

Associate Director, GCP/GLP/GVP QA

Description

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