Quality Assurance Operations Lead, QMS & GMP

KINOVATE LIFE SCIENCES, INC; Carlsbad (CA); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Discretionary bonuses

Health insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

401(k)

Vacation (3 weeks)

Paid holidays (12)

Paid sick days (5)

Tuition reimbursement

Job summary

Kinovate Life Sciences, Inc. seeks a Quality Assurance leader to sustain and improve the QMS in a GMP/ICH/ISO environment. You will lead QA staff, coordinate CAPA programs, and oversee audits, ensuring products meet regulatory standards.

The role emphasizes cross-functional collaboration, data-driven decision making, and continuous improvement to support Kinovate’s growth and compliance objectives.

Qualifications

• Bachelor’s degree in a scientific discipline; five (5) years’ related experience in a GXP or ISO manufacturing environment.
• Experience migrating from paper-based to electronic QMS systems is preferred.
• Strong knowledge of ISO 9001 and cGMP standards.
• Lean or Six Sigma knowledge is a plus.

Responsibilities

• Develop and maintain the Quality Management System (QMS) and ensure regulatory compliance.
• Oversee daily QMS operations and critical quality processes (Incoming Material, Final Product, CAPA, Change Control).
• Lead investigations, deviations, OOS/OOT and cross-functional meetings.
• Administer Master Control, troubleshoot, and optimize the system.
• Report QA metrics and drive continuous improvement through the QMS.
• Supervise, mentor, and develop QA staff; conduct performance reviews.

Skills

Quality management

GxP knowledge

ISO 9001

cGMP

Leadership

Documentation

Root cause analysis

Cross-functional collaboration

Training

Education

Bachelor's degree in a scientific discipline

Tools

MasterControl

NetSuite

LIMS

Job description

Kinovate Life Sciences, Inc. seeks a Quality Assurance leader to sustain and improve the QMS in a GMP/ICH/ISO environment. You will lead QA staff, coordinate CAPA programs, and oversee audits, ensuring products meet regulatory standards.

The role emphasizes cross-functional collaboration, data-driven decision making, and continuous improvement to support Kinovate’s growth and compliance objectives.