Manager, Quality Systems

Job Description

We are seeking a highly motivated individual who demonstrates growth mindset to join us as Manager, Quality Systems to support pipeline programs and manage the activities of the RDMC Quality Systems department in our Clinical Manufacturing facility located in Santa Monica, CA. This position reports to the Associate Director of QA and QS at RDMC.

Responsibilities:

• Manage Quality Systems staff including recruitment, performance management, hiring along with staff training and development.
• Implement risk based and phase appropriate QMS and ensure the site maintains agility and good collaboration with Process Development and Analytical Development to reduce RFD to IND timelines.
• Provide oversight, own, and mature the Quality Management Review (QMR) process. Ensure compliance with regulatory requirements and internal policies.
• Provide guidance to staff to ensure that the Quality Management Review process are followed through in a comprehensive, compliant, and timely manner.
• Identify KPIs for Quality Systems and report to various tiers and governances.
• Work closely with Global Quality Systems Owners and represent site at network meetings (Change Controls, Deviation/CAPA, Training, Doc Control). Share best practices, identify and implement improvements.
• Manage Doc Control and Issuance of batch records and in-process labels for patient lots.
• Manage Change Control process, mature the process and ensure change controls are assessed by required functions and followed through per plan and timeline.
• Report metrics, including analysis of trends and recommendations on corrective actions. Develop extensive plan to address repeat non-conformances. Present and escalate to stakeholders as needed.
• Manage deviation review board and ensure all product-related Deviations and CAPAs are initiated, investigated and resolved in a timely fashion.
• Develop appropriate training material to facilitate training on quality systems.
• Quality System SME for regulatory inspections and internal audits. Provide QS support during inspections.
• Review and approve quality system records as needed.
• Ensure cross-training and support with the QA Operations team.

Basic Qualifications:

• PHD/PharmD OR
• Master’s Degree and 4+ years of relevant experience in Biopharmaceutical or Biologics OR
• Bachelor’s Degree and 6+ years of relevant experience in Biopharmaceutical or Biologics OR

Preferred Qualifications:

• Degree in the biological sciences, engineering or related field.
• Demonstrated ability to think in a risk-based manner.
• Cell Therapy experience preferred.
• Knowledge and experience with a phase appropriate Quality Systems in a highly regulated manufacturing environment.
• 5+ years of prior experience developing Quality Systems group.
• 3+ years of experience managing QMR, Change Review Board and Deviation Review Board required.
• Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211, ICH Q8, ICH Q9, ICH Q10)
• Knowledge and experience with Quality System metrics, trending, Quality Risk Management and Metric Control Plans.
• Understanding of aseptic manufacturing and/or cell therapy processes.
• Knowledge and understanding of FDA, EMEA and other global regulatory compliance guidelines specific to Quality Systems.
• Skills, knowledge, and experience in Project Management.
• Comfortable interacting with regulatory agencies as needed.
• Demonstrates excellent verbal, written, and interpersonal communication skills.
• Demonstrated ability to develop, guide, and mentor direct reports
• Comfortable in a exciting company environment with minimal direction and able to adjust workload based upon changing priorities

Does this sound like you? If so, apply today!

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