Executive Director, GCP & CSV Quality Assurance

The Celito Team

Celito Tech Inc. is a leading partner in the biotech industry, specializing in helping companies scale from early clinical phases to pivotal trials and commercialization. We provide a full suite of operational and scale-up services, including Core IT Infrastructure & Support, Cybersecurity, QA (IT and GCP), and Regulatory Compliance, to ensure our clients achieve their goals efficiently and compliantly. Our team is dedicated to advancing the biotech industry with innovative solutions, a commitment to excellence, and fostering long-term client partnerships that drive sustainable growth.

We pride ourselves on our collaborative innovation, working closely with both internal teams and external partners to develop cutting-edge solutions that propel our clients to the forefront of the biotech industry. With a focus on expanding our global footprint, we aim to be the strategic partner of choice for biotech companies worldwide.

JOB OVERVIEW

Celito Tech Inc. is seeking a highly experienced and strategic Executive Director of Quality Assurance to lead our QA function. This role demands deep expertise in GCP, quality IT, and CSV (Computer System Validation) work. The ideal candidate will excel at managing multiple client engagements, working closely with quality heads at biotech companies to drive quality initiatives, and ensuring best practices across various projects.

KEY RESPONSIBILITIES

• Provide strategic direction and leadership to the Quality Assurance team to align services with client needs and industry practice.
• Advise, develop and implement quality strategies required for GCP and CSV compliance for biotech clients.
• Collaborate closely with client quality heads to understand their needs and drive quality improvements.
• Oversee the development, implementation, and maintenance of comprehensive GCP and CSV quality systems for biotech clients, ensuring regulatory compliance.
• Ensure all quality systems and processes are robust, efficient, and aligned with industry best practices.
• Act as the primary point of contact for client heads of quality, ensuring effective communication and collaboration.
• Manage multiple client engagements, customizing quality strategies to fit each client’s regulatory environment.
• Identify and mitigate quality risks in clinical operations activities, providing expert guidance on best practices.
• Lead and mentor internal Quality Assurance team, fostering a culture of continuous improvement.
• Ensure the team is trained and equipped to meet GCP Regulations and CSV industry practice and client expectations.
• Collaborate with client clinical and IT teams to integrate quality standards into all processes.
• Provide guidance to help client project teams navigate complex GCP regulatory landscapes and ensure project success.
• Establish and monitor key quality metrics for client projects to track performance and identify improvements.
• Report quality performance and issues to senior management to ensure transparency and strategic alignment.

QUALIFICATIONS

• Advanced degree (Master’s or Ph.D.) in Life Sciences, Biotechnology, or a related field.
• At least 20 years of experience in a QA leadership role within the US biotech or pharmaceutical industry, with extensive GCP experience.
• Proven ability to lead quality assurance teams and manage complex quality systems.
• Expert knowledge of US FDA and ICH GCP regulations and industry practice.
• Direct FDA interaction and inspection experience is required.
• Strong understanding of quality IT/CSV systems and processes.
• Familiarity with GMP practices, with GCP as the focus.
• Excellent problem-solving, decision-making, and interpersonal abilities.
• Proficiency in project management, communication, and quality management tools.
• Previous experience managing internal QA activities and providing QA advice in a consulting environment with multiple clients.
• Certification in Quality Assurance (e.g., ASQ Certified Quality Auditor) including managing and implementing electronic quality management systems (eQMS), a plus.

The wage range for this role takes into account the wide range of factors that are considered in making compensation decisions including but not limited to skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Celito, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current range is 225k - 290k per annum. Bonus target, 401k with matching, flexible PTO and Medical Benefits are in addition to.