Manufacturing QMS Supervisor

Company Overview

Creating a Healthier World through Accessible Biologics:

Kashiv BioSciences, LLC is a fully integrated biopharmaceutical company. Kashiv BioSciences, LLC in the United States, and its subsidiary, Kashiv BioSciences Private Limited in India (together “Kashiv BioSciences”), operate together with robust infrastructure and highly skilled teams that provide global R&D, clinical, manufacturing, regulatory, and IP capabilities. We believe our people, partners, and shared purpose fuel our work to advance patient care and access to important medicines.

Position Summary

The Manufacturing QMS Supervisor position is responsible for Process Improvements (deviation investigations, change controls, CAPA’s), Documentation Control (generate, review, and update SOPs, batch records, and quality manuals), Audit and Compliance reviews, and Cross-Functional Support (train staff on quality policies, adherence to current Good Manufacturing Practice (cGMP), and collaboration with supporting groups for resolution of issues) within a mammalian cell-based cultures and producing recombinant proteins manufacturing facility for a wide range of mammalian based biosimilars.

The candidate will be responsible for setting clear standards and goals for product quality, supervising deviation investigations, non-conformities, change controls, CAPA’s, SOPs, batch records, and quality manuals.

Essential Duties & Responsibilities

• Provide supervision for the QMS process at multiple scales for a cGMP environment.
• Provide technical oversight and direction in the execution of QMS related processes.
• Prepare / review all quality management related documents (Deviation / Change control / investigation reports etc.)
• Routine review of in-process batch records for timely closure.
• Lead audit review, manage corrective and preventative actions (CAPA), support internal audits, and support external regulatory inspections.
• Use various programs to collect and evaluate operating data to conduct sound information for relevant documentation.
• Analyze quality data and metrics to identify operational trends, root cause, and areas for continuous improvement.
• Audit and Compliance review to ensure staff are trained in quality policies and adhere to current Good Manufacturing Practice (cGMP).
• Cross-Functional Collaboration with supporting groups and vendors to resolve technical issues.
• Works with other teams and outside vendors to resolve technical issues as well as maintenance of production equipment.
• Adhere to all cGMP instructions in the manufacturing area and lead by example by following environmental health and safety policies.
• Comply with all company policies and standards.