Mirrai Careers

Associate Director, Quality Systems

Landmark Bio

Watertown, MA Full-time Posted 10d ago
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The Associate Director, Quality Systems leads the strategy, design and continuous improvement of the Quality Management System supporting Artis BioSolutions' cell therapy, viral vector and fill-finish operations. The role owns core quality systems, including document management, change control, deviations, CAPA, training, supplier quality, and risk management. This individual will also lead audit readiness, and supplier and client audits. Throughout, it ensures these systems remain phase-appropriate, scalable and compliant with regulatory expectations.  The Associate Director builds and leads the Quality Systems team and partners closely with Technical Operations, Quality Control, Process Development and Data Technology Integrations. Through metrics, risk-based decision-making and a strong quality culture, the position enables the Quality department to support operations efficiently. In doing so, it advances Artis BioSolutions' mission of helping innovators bring life-changing therapies from bench to clinic.  SCOPE OF RESPONSIBILITIES * Own the strategy, design and continuous improvement of the Quality Management System, ensuring it is phase-appropriate, scalable and aligned with company growth from early clinical through late-stage development.  * Establish and maintain the quality manual, quality policies and the governing procedure hierarchy.  * Serve as the process owner for core quality systems including  * Documentation Management  * Training  * Deviations, CAPA, Effectiveness Checks  * Change Control  * Supplier Quality and Change Management  * Quality Risk Management  * Audit Management, including Supplier, Client and Internal    * Implement a quality risk management program consistent with ICH Q9(R1), and embed risk-based decision making across Quality and operational functions.  * Ensure compliance with applicable regulations and guidance documents  * Lead the company’s supplier, client and internal audit readiness program  * Support front-room or back-room audits, oversee timely and high-quality audit responses  * Own the internal audit program, including annual audit planning, execution, reporting and CAPA follow-up  * Oversee supplier qualification and monitoring program, including risk-based supplier audits and performance management  * Define, trend and report key quality metrics and indicators to identify systemic risks and improvement opportunities  * Lead the quality management review process and escalate significant compliance risks to senior leadership  * Build, lead and develop high-performing Quality Systems team, including recruiting, setting performance objectives, coaching and planning career development discussions  * Manage and own the Change Control Review Board  * Partner with internal cross-functional stakeholders to foster a strong Culture of Quality, promoting shared accountability for compliance and right-first-time performance  * Influence internal cross-functional stakeholders to drive timely closure of quality records  REQUIRED EXPERIENCES Education  * Minimum Bachelor’s degree is STEM, such as biology, chemistry and engineering  Experience  * 8+ years of Quality experience working in a GMP biotechnology manufacturing environment, ideally with hands-on experience in cell and/or gene therapy  * 5+ years of effective management and strong leadership experience  Knowledge & Skills  * Subject matter expertise in Quality Systems in a GMP biotech setting  * Preferred experience with Veeva Vault  * Relevant phase-appropriate GMP experience  Preferred Qualifications  * Preferred ASQ certification     PHYSICAL / WORK REQUIREMENTS * Work environment: Office  * On-site expectations: 3 days on site per week  * Physical requirements: Standing, light lifting, ability to wear PPE when required   * Travel: None  * Schedule requirements: Monday – Friday, administrative hours  * Other requirements: N/A  TO APPLY   Please submit your resume/CV along with a brief cover letter describing your relevant experience for one or more applicable areas indicated above.     Landmark Bio is an Equal Opportunity, Affirmative Action employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply.   We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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