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Description
JOB SUMMARY
The Associate Director, Quality Assurance and Compliance is responsible to implement and support 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 are in compliance with current Good Clinical Practices (cGCP) and governmental regulations through 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 Clinilabs' 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 Clinilabs 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 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% traveling between Clinilabs' New Jersey, vendors, sponsors and other investigational sites, as needed.
Salary range between $130,000 - $150,000. Final compensation is based on skills, experience, location, and overall expertise.
Requirements
- The position requires at least a Bachelor's degree, although advanced degrees are preferred.
- A minimum of 8 - 10 years working within GXP function is required.
- A minimum of 5 years of experience in a leadership role in quality and/or compliance is required.
- Strong influencing, negotiations and leading 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.
- The selected candidate must come from a regulated industry.
- Ability to work and communicate in a cross-cultural environment is highly required.
- Previous experience driving performance results is required