Senior Manager, Quality Systems

About Capricor Therapeutics

Capricor Therapeutics is a pioneering biotechnology company dedicated to transforming the lives of patients through groundbreaking therapies for severe and complex diseases. Focused on advancing cell and exosome-based technologies, we aim to address critical medical needs, including Duchenne muscular dystrophy. Our mission to redefine healthcare through cutting-edge science is rooted in an unwavering commitment to improving patient outcomes. Join our passionate team where innovative science meets patient-centered care.

Position Overview:

We are seeking a self-motivated team player who is meticulous and has a keen eye for detail. The successful candidate should have a knack for organization, a drive for improving processes, and a desire to make a difference in patient lives. The selected candidate will serve an essential role in supporting clinical product launch and production, reporting to the Associate Director of Quality Assurance. Knowledge of standard processes involved in document control and experience in an FDA-regulated environment is required.

Responsibilities: 

• Lead the development, implementation, and maintenance of Quality Management Systems (QMS) to ensure compliance with FDA, EMA, and other global regulatory requirements for cell therapy products.
• Oversee and enhance document control systems, CAPA management, change control, and training programs.
• Drive the implementation and optimization of electronic quality management systems (eQMS), with experience in Veeva systems highly desirable.
• Collaborate with cross-functional teams to support quality processes, risk assessments, and audits.
• Ensure readiness for regulatory inspections and audits, acting as the point of contact for quality systems-related inquiries.
• Develop and work with quality excellence counterpart to manage metrics and dashboards to monitor quality system performance and identify opportunities for improvement.
• Provide guidance and training to the quality team and other stakeholders on quality systems and compliance requirements.
• Lead the investigation of deviations from standard operating procedures (SOPs), ensuring thorough root cause analysis, impact assessment, and documentation. Collaborate and provide guidance with cross-functional teams and individuals to identify root causes and implement appropriate corrective actions.
• Oversee, manage, and provide guidance on the CAPA process from initiation to closure, including the development of action plans, effectiveness checks, and documentation. Ensure CAPAs are addressed in a timely and effective manner to prevent recurrence of deviations.
• Utilize strong technical writing skills to prepare clear, concise, and comprehensive deviation reports and CAPA records. Provide and train other teams on proper technical writing requirements. Ensure all documentation meets regulatory requirements and is ready for internal and external audits.
• Working knowledge of 21 CFR 210 and 211, ICH, ISO9001, EU Guidelines, and other relevant FDA regulations is a must.
• Process controlled documentation through the GxP (GLP / GCP / GMP) documentation system, including but not limited to word processing, tracking, issuing, distributing, and archiving, utilizing manual or an electronic document management system.
• Coordinate, track, and archive controlled records (ex: deviations, CAPAs).
• Write and/or review policies, standards, procedures, and work instructions to document Quality documentation processes and practices.
• Support regulatory/submission activities.
• Perform other required duties as may be assigned.

Requirements: 

• 6–10 years of experience in Quality Systems within the biotech or pharmaceutical industry, preferably in cell therapy or advanced therapeutics.
• Experience in a commercial cell therapy company is highly desired.
• Strong knowledge of GxP regulations, including FDA 21 CFR Part 11, EU Annex 11, and ICH guidelines.
• Hands-on experience with Veeva Quality Management Software (Veeva Vault) or similar eQMS platforms is highly desirable.
• Proven track record of leading quality systems projects, including CAPA, change control, and document management.
• Experience preparing for and participating in regulatory inspections.
• Experience in Aseptic Processing is a plus.
• Attention to detail and excellent record-keeping skills.
• Strong, demonstrable computer skills in MS Word, Excel, Visio, Access; Adobe suite; and database systems.
• Good oral and strong written communication skills.
• Strong problem-solving skills and the ability to coordinate and perform multiple activities.
• Results-oriented with dedication to compliance and customer service.
• Strong initiative, independence, and follow-through.
• Comfortable working in a fast-paced, cross-functional team in a dynamic environment.
• Comfortable dealing with rapidly changing priorities.

Work Environment and Physical Demands: 

• Must be able to sit and stand for extended periods.
• Must be able to lift/carry reports and materials up to 40 pounds, move about the office, communicate efficiently and effectively on the telephone or in person, and complete required paperwork.

Why Capricor?

Capricor Therapeutics is an industry leader in cell and exosome therapy, pushing boundaries to create innovative treatments that raise the standard of care. Grounded in integrity and driven by science, our team is committed to making a meaningful impact through patient-centered innovation. Join us and be part of a team that’s changing lives—help us shape the future of healthcare.

Compensation (USD): 

Salary Range: Competitive, based on experience.

Comprehensive benefits package, including health insurance, retirement plans, and opportunities for professional development.

Come work with us!

At Capricor, we offer a collaborative work environment that supports your professional growth. Join a passionate team committed to transforming the lives of patients and pushing the boundaries of medical science.