Associate Director Quality Assurance (GCP)

Our client, a small company focused on early phase (I/II) CNS clinical research is currently hiring! Full-time, remote opportunity to join a GREAT team! Up to 20% travel and home-based!

Associate Director, Clinical QA

JOB SUMMARY

The Associate Director, Quality Assurance and Compliance is responsible for implementing and supporting strategies for Quality System processes and supporting technology, and ensuring the integrity, consistency, and harmonization of these processes and systems, with a particular emphasis on global clinical operations (GCO) activities.

This individual is also accountable for ensuring that the clinical activities comply with current Good Clinical Practices (cGCP) and governmental regulations through the creation and maintenance of quality and compliance systems that relate to GCO, including those monitor quality, efficiency, and uniformity of clinical trials and associated activities, both internally & externally.

The Associate Director, Quality Assurance and Compliance will provide regulatory expertise regarding all regulatory submissions for site services, clinical research organizations, client companies, and internal project teams on regulatory requirements for all company activities.

RESPONSIBILITIES

• Provide leadership and direction to a growing quality and regulatory department
• Manage and provide leadership and organizational capability development for quality system, to ensure succession planning and performance standards remain at an optimal level
• Make decisions on process and system strategy recommendations, defining compliance-driven standards, determining boundaries for harmonization and alignment versus differentiation
• Provide leadership in setting strategy, implementing, and maintaining company's Quality Systems
• Act as quality systems subject matter expert and resource leader for focus areas by partnering with process owners to drive results by identification, selection, and/or facilitation skills
• Provide leadership and guidance for computer system and software validation, with particular focus on GCP / regulated systems
• Conduct internal and external audits in compliance with company SOPs
• Provide feedback to the quality control (QC) group
• Establish processes, standards, and procedures (as required); and ensure they remain current with regulatory requirements.
• Interact with the FDA and other regulatory bodies
• Provide qualification audits of contractors and vendors, as needed
• Provide leadership and guidance on quality agreements
• Develop measures to monitor the effectiveness of the deployed quality system
• Identify potential quality issues and/or areas for improvement
• Monitor employee training and training program
• Oversight of controlled document management system
• Conduct / oversee Internal and external audits
• Develop and/or monitor vendor qualification program
• Other duties as assigned

TRAVELING

Up to 20% travel to company locations, vendors, sponsors, and other investigational sites, as needed.

Requirements

• The position requires at least a bachelor’s degree, although advanced degrees are preferred.
• A minimum of 8 – 10 years working within the GXP function is required. Strong GCP needed.
• A minimum of 5 years of experience in a leadership role in quality and/or compliance is required.
• Strong influencing, negotiations, and leadership without direct line authority experience is required.
• The ability to manage complexity and manage a diverse team is critical.
• Excellent written and oral communication and interpersonal relationship skills are required.
• Excellent leadership, influencing, and collaboration skills are expected.
• Ability to work and communicate in a cross-cultural environment is highly required.
• Previous management experience required.