Associate Director of Quality Assurance

Nivagen Pharmaceuticals Inc, USA
Associate Director /Director of Quality Assurance,

Sterile Injectable Manufacturing Facility, USA

Company:

Nivagen pharmaceuticals Inc. located in Sacramento CA is in the process of setting up a Greenfield project for multiple sterile dosage forms such as vials, PFS, Cartridges, and IV Bags. Currently, all our products are being manufactured by a Contract Manufacturing company (CMO). Eventually, these products will be manufactured at the proposed facility. The Proposed facility is spread over 85000+ Sq. Ft footprint which has manufacturing and packing functions along with Quality control Labs, R&D, and administration offices.

Position Summary

As the Associate Director of Quality Assurance (Sterile Injectable), you will play a crucial role in leading, maintaining and enhancing our quality assurance processes. You will collaborate with cross-functional teams to ensure compliance with regulatory requirements and drive continuous improvement initiatives. This position offers an exciting opportunity to contribute to the launch of insulin biosimilars, making affordable options available to patients.

Responsibilities

• Develop and implement comprehensive quality strategies to ensure the consistent production of high-quality Sterile Injectable dosage form
• To provide support for Manufacturing and QC Laboratories (GxP). This includes clinical and commercial manufacturing, release and stability testing, method validation and transfer, inspection support, and overall compliance.
• Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.
• Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
• Quality Assurance Lead for major quality investigations/deviations/clinical/market complaints, represents QA on quality event escalation meetings, and effectively communicates and escalates major and/or critical events to upper management in a timely manner.
• Interfaces with Management Teams to address site documentation and compliance issues.
• Work closely with the regulatory affairs department to ensure quality and compliance issues related to customer complaints, adverse events, quality events, market recalls, and pharmacovigilance reporting.
• Perform 3rd party vendor audits. Vendors including contract manufacturing organizations, 3rd party logistics, contract research organizations, contract research laboratories, API manufacturers, raw material suppliers, primary/secondary packaging material supplier.
• Conduct periodic reviews and audits to identify areas for improvement and ensure continuous compliance with quality standards.
• Monitors for, receives notification of, and initiates internal tracking records for plant exception events and maintains associated metrics.
• Communicate effectively with internal stakeholders, management, and external parties regarding quality-related matters, including deviations, investigations, and corrective actions.
• Implement a risk management framework to identify and mitigate potential quality risks associated with the manufacturing processes, products, or regulatory requirements. Conduct risk assessments, develop risk mitigation strategies, and monitor the effectiveness of implemented controls.
• Participates in writing, reviewing and approving controlled documents, as needed.
• Lead compliance and regulatory audits, as required. interface with regulatory agencies, as required.
• Active participant on projects, initiatives, and process improvements.
• As a quality functional site lead responsible for providing quality metrics, trend reviews, and risk assessments.
• Guide and execute quality assurance activities related to drug product manufacturing.
• Ensure compliance with cGMP (current Good Manufacturing Practices) and other relevant regulations.
• Mentor and develop quality assurance team members.

Qualifications

• Strong knowledge of regulatory requirements for Sterile Injectable dosage forms
• Expert knowledge of cGMP, ICH, USP, and FDA quality guidelines and regulations
• Minimum of 15+ years of experience in quality assurance within the pharmaceutical industry.
• Excellent communication and leadership skills.
• Ability to work effectively in a cross-functional environment.