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Quality Assurance Compliance Lead
2 months ago
Position Title: Quality Compliance Supervisor
Capricor Inc. is in search of a dedicated and detail-oriented professional to fill the role of Quality Compliance Supervisor. The ideal candidate will possess exceptional organizational skills and a commitment to enhancing operational processes, all while positively impacting patient outcomes. This pivotal position will be instrumental in facilitating the launch and production of commercial products.
Key Responsibilities:
- Oversee and support international teams across multiple locations in managing Global Change Control and Global Deviation/CAPA processes.
- Ensure readiness for Regulatory Inspections by developing comprehensive training programs.
- Administer Global document control functions, establishing corporate policies and workflows.
- Supervise the traceability of final drug products across different sites.
- Manage specifications for final products across multiple locations.
- Possess a solid understanding of relevant regulations, including 21 CFR 210 and 211, 600, ICH, ISO9001, and EU Guidelines.
- Review completed deviations, CAPA actions, change controls, training, and internal audits, providing constructive feedback to stakeholders.
- Process controlled documentation through the GxP documentation system, ensuring accurate tracking, issuing, and archiving.
- Collaborate on the development and enhancement of quality management systems as assigned.
- Draft and review policies, standards, procedures, and work instructions related to Quality documentation.
- 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 experience.
- Experience in a commercial cell therapy organization is highly desirable.
- Familiarity with Aseptic Processing is advantageous.
- Strong attention to detail and excellent record-keeping capabilities.
- Proficient in MS Word, Excel, Visio, Access, Adobe Suite, and database systems.
- Effective oral and written communication skills.
- Knowledge of Quality Systems and records management in a cGMP setting.
- Strong problem-solving abilities and capacity to manage multiple tasks simultaneously.
- Results-driven with a focus on compliance and customer service.
- Self-motivated, independent, and able to follow through on tasks.
- Comfortable in a fast-paced, cross-functional team environment with shifting priorities.
Work Environment:
- Ability to sit and stand for extended periods.
- Capability to lift and carry materials weighing up to 40 pounds.
- Effective communication skills for both telephone and in-person interactions.
- Willingness to work extended hours as necessary to meet operational needs.
