Manager/Senior Manager of Manufacturing

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

• Provide end-to-end documentation support from the India team and work virtually with 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 Master’s degree in Pharmacy, Chemical Engineering, Biotechnology, or related field.
  

• 10–15 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