Quality Assurance Compliance Lead

1 week ago

San Diego, California, United States Capricor Inc Full time
Job Overview

Position: Quality Compliance Supervisor

We are in search of a detail-oriented and proactive individual who excels in a collaborative environment. The ideal candidate will possess exceptional organizational skills, a commitment to enhancing operational processes, and a passion for positively impacting patient outcomes. This pivotal role involves supporting the launch and production of commercial products.

Key Responsibilities:

  • Oversee and facilitate global teams across multiple locations, focusing on Global Change Control Management and Global Deviation/CAPA Management.
  • Ensure readiness for Regulatory Inspections at two sites by developing comprehensive training programs.
  • Direct Global document control initiatives, establishing suitable corporate policies and workflows.
  • Manage traceability of final drug products across multiple sites.
  • Supervise final product specifications across various locations.
  • Possess a solid understanding of 21 CFR 210 and 211, 600, ICH, ISO9001, EU Guidelines, and other pertinent FDA regulations.
  • Review completed deviations, corrective and preventative actions (CAPA), change controls, training, and internal audits, providing detailed reports and feedback.
  • Process controlled documentation through the GxP (GLP / GCP / GMP) documentation system, including tracking, issuing, distributing, and archiving.
  • Collaborate on the development and enhancement of quality management systems as assigned.
  • Draft and/or evaluate policies, standards, procedures, and work instructions to formalize Quality documentation processes.
  • Assist in regulatory and submission activities.
  • Prepare relevant materials for Management Review and Material Review Board meetings.
  • Perform additional duties as required.

Qualifications:

  • Bachelor's Degree with a minimum of 5 years of experience in a cGMP environment, including supervisory responsibilities.
  • Experience in a commercial cell therapy organization is highly preferred.
  • Familiarity with Aseptic Processing is advantageous.
  • Meticulous attention to detail and strong record-keeping abilities.
  • Proficient in MS Word, Excel, Visio, Access, Adobe suite, and database systems.
  • Excellent verbal and written communication skills.
  • Knowledge of Quality Systems and records management in a cGMP setting.
  • Strong analytical skills with the ability to manage multiple tasks effectively.
  • Results-driven with a focus on compliance and customer service.
  • Demonstrated initiative, independence, and follow-through.
  • Able to thrive in a fast-paced, cross-functional team environment.
  • Adaptable to changing priorities.

Work Environment / Physical Requirements:

  • Ability to sit and stand for extended periods.
  • Capable of lifting and carrying materials up to 40 pounds, moving around the office, and communicating effectively.
  • Willingness to work extended or off-hours as needed to accommodate manufacturing schedules.

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