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Artis BioSolutions is seeking an Associate Director of Quality Systems to own the strategy, design, and continuous improvement of the Quality Management System. This role is critical for a biotech company scaling from early clinical through late-stage development, ensuring the QMS is phase-appropriate, scalable, and aligned with company growth.
Key Responsibilities:
You will establish and maintain the quality manual, quality policies, and the governing procedure hierarchy. You will serve as the process owner for core quality systems including documentation management, training, deviations, CAPA, effectiveness checks, change control, supplier quality and change management, and quality risk management.
You will implement a quality risk management program consistent with ICH Q9(R1) and embed risk-based decision making across Quality and operational functions. You will ensure compliance with applicable regulations and guidance documents.
You will lead the company's supplier, client, and internal audit readiness program, support front-room and back-room audits, and oversee timely and high-quality audit responses. You will own the internal audit program, including annual audit planning, execution, reporting, and CAPA follow-up.
You will also be responsible for managing regulatory interactions and submissions, supporting quality-related regulatory strategy, and serving as a subject matter expert on quality systems and regulatory requirements.
Workplace Details:
On-site expectations: 3 days per week in Watertown, MA. Physical requirements include standing, light lifting, and ability to wear PPE when required. No travel required. Monday–Friday, administrative hours.
Requirements:
The posting excerpt provided does not include a dedicated requirements section. Candidates should review the full posting for specific experience, education, and qualification expectations.
