Assistant Manufacturing Manager

Position Summary

The Manufacturing Manager/Senior Manager will provide technical, documentation, and quality system support to on-site manufacturing operations. This role involves managing manufacturing documentation, monitoring performance metrics, driving process improvements, and coordinating with cross-functional teams to ensure seamless execution of production activities in alignment with cGMP standards.

Key Responsibilities:

Documentation & Quality System Support

• Responsible for document support from back-end team and working virtually to the on-site U.S. team.
• Initiate and review Change Controls, Deviations, and CAPA within the Quality Management System (QMS).
• Prepare and review Standard Operating Procedures (SOPs) for manufacturing operations.
• Maintain and track QMS data related to CAPA, deviations, and change controls.
• Review new Batch Manufacturing Records (BMRs) and ensure completeness and compliance.

Manufacturing Operations & Training

• Provide virtual training to the manufacturing team on procedures, best practices, and documentation.
• Conduct training on cleanroom requirements, aseptic behavior, and standard practices followed during manufacturing.
• Support on-site teams in ensuring adherence to cGMP and company SOPs.

Data Monitoring & Reporting

• Prepare NVPC (Non-Value-Added Process Cost) trend reports and other manufacturing-related metrics.
• Monitor KPIs, analyze manufacturing data, and prepare presentations for management review.
• Support capacity planning, performance monitoring, and operational efficiency improvements.

Process Improvement & Optimization

• Work on projects related to process improvement, yield optimization, and cost-saving initiatives within the manufacturing department.
• Collaborate with engineering and quality teams to implement process changes and track effectiveness.

Cross-Functional Collaboration

• Communicate effectively with cross-functional teams including QA, QC, Supply Chain, Engineering, and Operations.
• Coordinate with the quality team to ensure timely completion of document preparation and review.
• Ensure alignment between virtual support activities and on-site operational needs.

Qualifications & Requirements:

• Bachelors or Masters degree in Pharmacy, Chemical Engineering, Biotechnology, or related field.
• 08-12 years of experience in pharmaceutical manufacturing, sterile operations preferred.
• Strong knowledge of cGMP, GDP, aseptic processing, and documentation practices.
• Hands-on experience with QMS software (TrackWise, MasterControl, SAP QMS, or similar).
• Experience in authoring and reviewing BMRs, SOPs, and deviation/CAPA management.
• Strong analytical, problem-solving, and project management skills.
• Excellent communication skills with the ability to train and guide teams virtually.
• Ability to work independently and collaboratively in a fast-paced environment.

Key Competencies:

• Leadership & Team Guidance
• Documentation Accuracy
• Quality & Compliance Orientation
• Strong Analytical Skills
• Communication & Training Expertise
• Process Improvement Mindset
• Cross-Functional Collaboration