Manufacturing Quality & Process Improvement Lead

Medivant Healthcare; United States; Remote; USD 120,000 - 160,000; Full time

Job summary

Medivant Healthcare is seeking a Manufacturing Manager/Senior Manager to oversee on-site pharmaceutical manufacturing operations, driving cGMP-compliant processes, documentation, and continuous improvement. The role involves coordinating with QA, QC, Engineering, and Supply Chain to ensure efficient production and robust data reporting.

You'll manage BMR/SOP authoring, CAPA and deviation handling within QMS, deliver virtual training to teams, and monitor KPIs while leading cross-functional

Qualifications

• Bachelor's or Master's 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.

Responsibilities

• Provide technical, documentation, and quality system support to on-site manufacturing operations.
• Initiate and review Change Controls, Deviations, and CAPA within the QMS.
• Prepare and review SOPs for manufacturing operations.
• Maintain and track QMS data related to CAPA, deviations, and change controls.
• Review new BMRs and ensure completeness and compliance.
• Provide virtual training to the manufacturing team on procedures and best practices.
• Support on-site teams in adhering to cGMP and SOPs.
• Prepare NVPC trend reports and other manufacturing metrics.
• Monitor KPIs and prepare presentations for management review.
• Support capacity planning and continuous improvement initiatives.
• Collaborate with engineering and quality teams on process changes.

Skills

Leadership

Documentation Accuracy

Quality & Compliance

Analytical Skills

Communication & Training

Process Improvement

Cross-Functional Collaboration

Education

Bachelor's or Master's in Pharmacy, Chemical Engineering, Biotechnology, or related field

Tools

TrackWise

MasterControl

SAP QMS

Job description

Medivant Healthcare is seeking a Manufacturing Manager/Senior Manager to oversee on-site pharmaceutical manufacturing operations, driving cGMP-compliant processes, documentation, and continuous improvement. The role involves coordinating with QA, QC, Engineering, and Supply Chain to ensure efficient production and robust data reporting.

You'll manage BMR/SOP authoring, CAPA and deviation handling within QMS, deliver virtual training to teams, and monitor KPIs while leading cross-functional