Director, Quality Systems

We are a rapidly growing therapeutics company with an approved drug on the market, leveraging scientific advances in B-cell biology to develop novel treatment for patients.

The Associate Director/Director, Quality Systems plays a key role in overseeing all aspects of the quality management system (QMS), including the development, implementation, and maintenance of quality systems to ensure adherence to regulatory requirements and industry standards (cGMP).

The successful candidate will have experience implementing, maintaining, and optimizing Veeva (including system configuration) within a smaller biotechnology company supporting a commercial drug product and clinical pipeline.

This position will report to the VP of Quality Systems.

Key Responsibilities:

• Design, develop, configure, implement, maintain, and continuously improve Veeva (Quality and RIM Vaults) to ensure compliance with regulatory requirements (e.g., FDA, EMA), industry standards (e.g., cGMP), and company policies.
• Work with system users to provide analysis, solve issues, and provide training / mentoring and drive improvements
• Establish and maintain procedures, processes, and documentation (e.g., SOPs, policies, work instructions, etc.) to ensure compliance with regulatory requirements.
• Collaborate with cross-functional teams to ensure alignment on quality objectives, initiatives, and priorities.
• Develop and implement quality metrics, key performance indicators (KPIs), and dashboards to monitor the QMS's performance and drive continuous improvement. Periodically report quality metrics to key stakeholders in the company.
• In collaboration with Quality Leads, ensure the timely investigation and resolution of deviations, non-conformities, and customer complaints related to product quality, safety, or efficacy.
• Provide leadership, mentorship, and coaching to the quality system team, fostering a culture of quality excellence, accountability, and continuous learning.
• Serve as a subject matter expert on the Quality Management System during regulatory inspections, customer audits, and internal reviews, ensuring successful outcomes and compliance with requirements.
• Travel 10-15% of time for meetings, audits, and inspections.

Qualifications:

• University degree in life sciences or related field. Post-Graduate work is preferred.
• Minimum of 8+ years in Quality Systems/Quality Assurance/Quality Control in biopharma/biologics/pharmaceutical industry
• Demonstrated experience with implementing, optimizing, and maintaining QMS Software, specifically Veeva Quality. Experience with Veeva RIM is highly desirable
• Thorough knowledge of GxP (GMP, GLP, GCP, GVP) and Computer System Compliance regulations
• Demonstrated ability to broadly assess regulatory compliance audit findings and implement appropriate CAPA
• Technically proficient on system configuration, as you will serve as the technical expert on the system.
• Ability to troubleshoot, identify root causes, and systematically resolve problems
• Excellent communication and interpersonal skills, with the ability to effectively interact with stakeholders at all levels of both internal and external organizations.
• Ability to thrive in a fast-paced and dynamic environment, with a commitment to continuous improvement and innovation.