Quality Assurance Manager-Parenteral

About the Company:

Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence.

Job Location:

Nivagen Pharmaceuticals Inc., Sacramento, CA

3900 Duckhorn Dr, Sacramento, CA 95834

About the Job:

Title of the Position: Quality Assurance Manager-Parenteral (Full Time)

At Nivagen as Quality Assurance manager you will be responsible for overseeing and managing all QA activities related to the manufacturing of sterile injectable (parenteral) products. This includes ensuring compliance with cGMP regulations, internal quality standards, and applicable regulatory requirements (e.g., FDA, EMA, MHRA). The QA Manager will lead a team in managing quality systems such as deviations, CAPAs, change control, batch release, validation oversight, and audit readiness. The role requires close collaboration with production, QC, regulatory affairs, and engineering teams to ensure consistent product quality and continuous improvement.

Responsibilities:

• Perform on-the-floor QA tasks within the manufacturing areas as needed, collaborating with manufacturing and other departments to provide routine quality support, and maintain inspection readiness.
• Provide triage support across departments to address moderate quality issues, ensuring timely escalation to management when necessary.
• Review and approve deviations, including the associated investigation reports, and corrective/preventative actions.
• Review and approve change controls for appropriateness, completeness and alignment with quality, validation, and regulatory expectations.
• Review and approve sampling protocols, risk assessments, and master batch records.
• Author, review and approve SOPs as appropriate for both Operations and Quality.
• Assist with additional tasks, including (but not limited to) Master Data management / approval, GMP area walkthroughs, product changeover activities.
• Participate in internal audits, support regulatory inspections or customer audit activities, as needed.
• Maintain and update quality-related documents, records, and reports within the quality management system (QMS), ensuring accuracy, consistency, and regulatory compliance.
• Assist in the development or assignment of training to key stakeholders related to QMS.
• Contribute to the preparation of Periodic Quality Reviews.
• Assume responsibility for any additional quality-related activities delegated to the hub, ensuring effective management in alignment with Quality standards.
• Support the implementation of a quality culture and best practices within the affiliate organization

Qualifications:

Education/Experience:

• Candidates with a Bachelor’s degree must have at least 10 years of relevant experience; those with a Master’s degree require 5+ years of experience.
• Strong background in manufacturing and quality assurance within the pharmaceutical or biotechnology industry is essential.

Knowledge, Skills, and Abilities:

• Knowledge of cGMPs, Production Processes, Quality Systems, and FDA regulations
• Knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards.
• Proactive approach and strong critical thinking skills.
• Must be able to work in a team environment within own team and interdepartmental teams.
• Excellent communication and interpersonal skills.
• Experience in quality administered systems.
• Strong organizational skills and attention to detail.
• Experience with regula