Associate Director, Clinical Quality Assurance and Compliance

Invivyd; United States; Remote; USD 120,000 - 150,000; Full time

Job summary

A biopharmaceutical company is seeking an Associate Director for Clinical Quality Assurance and Compliance in the U.S. This role focuses on leading compliance activities for clinical development, ensuring adherence to GCP and FDA standards. Candidates should have at least 6 years of relevant experience, a scientific degree, and strong skills in audit management. The position is remote, with some regional travel required.

Qualifications

• Minimum of 6 years of relevant GCP experience in pharma/biotech.
• Experience leading FDA inspections and internal audits required.
• Strong understanding of GCPs, FDA, and ICH regulatory standards.

Responsibilities

• Build Clinical Quality Assurance function to support compliance activities.
• Develop and maintain GCP, GLP, and GVP systems and policies.
• Lead strategy for GCP health authority inspections.

Skills

GCP experience

Audit management

Regulatory standards knowledge

Risk-based quality systems

Adaptability

Education

Bachelor’s degree in a scientific discipline

Tools

Veeva Quality Vault

Job description

Associate Director, Clinical Quality Assurance and Compliance

Remote (Northeast Preferred)

Overview

The primary responsibility of the Associate Director of Clinical Quality Assurance and Compliance is to develop and lead all quality assurance and compliance activities for the clinical development organization. The role drives Clinical Quality initiatives in coordination with Regulatory, Clinical, and external vendors, and coordinates, controls, and improves internal QA processes related to clinical development and related activities and systems. The Associate Director coordinates audits to support GCP, GLP, GVP, and other regulated activities and leads strategy and activities in support of health authority inspections. The role ensures compliance of clinical trials and development activities with global regulatory standards including US FDA, ICH standards, and other international regulatory agencies, and leads clinical inspection readiness activities for development programs.

Responsibilities

• Build the Clinical Quality Assurance and Compliance function and infrastructure to support the Invivyd pipeline and other compliance-related activities, acting as Clinical Quality Assurance SME in cross-functional teams
• Create, implement, and maintain efficient, phase-appropriate, and compliant GCP, GLP, and GVP systems and policies/procedures
• Partner with stakeholders across Clinical Operations, Pharmacovigilance, Regulatory, IT, CMC Quality Assurance, HR, and Finance to develop and maintain cross-functional SOPs, policies, procedures, and systems aligned with corporate objectives
• Assist Clinical Development in establishing procedures for a risk-based oversight of clinical trials using quality by design and quality risk management; proactively identify potential quality issues and resolve them in a compliant and timely manner
• Provide Clinical Quality Support for vendor/CRO oversight, representing Invivyd Clinical Quality on sponsor/CRO/site calls and handling critical quality issues, protocol deviations, investigations, root causes, and CAPAs
• Develop a risk-based audit program to audit internal processes, investigator sites, and vendors; establish procedures and tools to support audit and compliance activities; collaborate on internal and external GCP audit plans
• Assist in developing, implementing, and maintaining training and compliance programs; responsible for GCP, GLP, and GVP training and sessions; partner with stakeholders to implement other training across the organization to ensure full compliance
• Proactively provide stakeholders with intelligence on changes to ICH and GCP regulations and assess impact on Invivyd systems and practices
• Lead strategy and activities in support of GCP, GLP, and GVP health authority inspections
• Review regulatory clinical and nonclinical documents (protocols, CSRs, IBs, ICFs, etc.) for consistency and compliance with applicable regulations, standards, and best practices
• Maintain excellent written and oral communication and organizational skills; effectively communicate complex information in a virtual environment and manage multiple priorities
• Collaborate cross-functionally and independently; adapt to changing business needs and timelines
• Identify and assess impact of issues on subjects, study conduct, and development programs based on development stage and risk
• Demonstrate strong attention to detail and problem-solving; act as a proactive, resourceful, self-starter and team player with a strong results orientation

Requirements

• Bachelor’s degree in a scientific discipline or biotechnology field
• Minimum of 6 years of relevant GCP experience in pharma/biotech with quality systems and regulated GCP/ICH environments
• Experience leading and facilitating inspection readiness activities and hosting FDA and other regulatory inspections
• Experience managing internal and external audits
• Strong understanding of GCPs, FDA, and ICH regulatory standards/guidance
• Extensive knowledge of risk-based quality systems approaches, with focus on ICH E6 R2 GCP principles
• Experience using Veeva Quality Vault
• Willingness to travel to clinical sites/vendors as required; travel up to 25%

Invivyd is an equal opportunity employer. We strive to create a welcoming and inclusive environment and provide equal employment opportunities without discrimination based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or other legally protected characteristics.

We do not accept unsolicited resumes from agencies.