Kashiv Biosciences

Job Type

Full-time

Description

Job Summary

Under the direction of Manufacturing Management, the Manufacturing QMS Supervisor is responsible for implementing, maintaining, and continuously improving the Quality Management System (QMS) to ensure manufacturing operations comply with applicable regulatory requirements, industry standards, and internal procedures.

This role provides hands-on leadership for manufacturing documentation and quality systems activities, including deviations, change controls, investigations, CAPAs, batch records, and SOPs. The position requires strong technical understanding of upstream and downstream biologics manufacturing processes, including cytokines and monoclonal antibodies.

Requirements

Essential Duties & Responsibilities

• Ensure SOPs, policies, and quality records are current, controlled, and compliant with GMP and regulatory requirements.
• Conduct QMS training for manufacturing personnel and QMS team members.
• Support internal and external audits, including preparation of audit responses and follow-up actions.
• Track, manage, and close audit observations in a timely manner.
• Create and maintain QMS trackers for manufacturing-related quality activities.
• Review executed batch records for both Upstream and Downstream manufacturing operations.
• Initiate, manage, and close change controls, deviations, and CAPAs for the Manufacturing department.
• Lead and support critical and major investigations using structured tools such as 5-Why and 6M methodologies.
• Participate in daily meetings with Upstream and Downstream teams to identify and support daily documentation needs.
• Coordinate weekly meetings with Quality Assurance (QA) to ensure timely closure of QMS activities.
• Author and revise batch records, SOPs, and associated forms and templates required for manufacturing processes.
• Request, submit, and track GMP documentation with QA in accordance with established procedures.
• Support manufacturing operations during critical campaigns or shifts, as required.
• Provide regular QMS status summaries and metrics to Manufacturing Management.
• Perform other duties as assigned.
• Comply with all company policies, procedures, and regulatory standards.

Qualifications

Education

• Bachelor’s degree (BA or BS) in Biological Sciences or a related technical discipline required.

Experience

• Minimum of 5–8 years of experience in the biopharmaceutical industry.
• Hands-on experience supporting GMP manufacturing operations.
• Working knowledge of upstream (USP) and downstream (DSP) processes.

Skills & Competencies

• Proficiency with Master Control or similar electronic QMS software.
• Strong knowledge of GMP documentation, batch record review, audits, and regulatory inspections.
• Experience with deviation management, CAPA, change control, and investigations.
• Knowledge of cleaning verification and validation activities.
• Strong interpersonal skills with the ability to work independently and cross-functionally.
• Excellent verbal and written communication skills.
• Strong organizational skills with attention to detail.
• Proficient in Microsoft Word, Excel, and PowerPoint.

Work Environment & Physical Demands

• Noise: No extraordinary noise levels.
• Standing/Lifting: No extraordinary physical requirements.
• Visual: No extraordinary visual demands.
• Stress: Fast-paced, high-demand environment with tight timelines and project goals.
• Travel: Minimal or none.

The employee must be able to work flexible hours as needed, manage multiple priorities, work under pressure, and consistently meet deadlines.