Aseptic Operations Manager: CGMP Leader & QA Innovator

Glenmark Pharmaceuticals Inc.; Monroe (NC); On-site; USD 120,000 - 180,000; Full time

Job summary

Glenmark Pharmaceuticals Inc. in Monroe, NC, seeks an experienced Aseptic Manufacturing Manager to lead a team of production supervisors, team leads and technicians responsible for aseptic processing and sterile liquids manufacturing. This role ensures CGMP compliance and acts as a liaison between site leadership and the floor.

The position emphasizes batch record ownership, process optimization, and a strong quality mindset to sustain audit readiness and timely production schedules.

Qualifications

• Bachelor degree required in a related field.
• 5–8 years CGMP/aseptic operations experience.

Responsibilities

• The Aseptic Manufacturing Manager is responsible for leading a team of production supervisors, team leads and technicians.
• Owns solution compounding, equipment cleaning, preparation, sterilization, aseptic filling, cleaning of classified areas and sterile liquids manufacturing.
• Serves as Liaison between site Senior Leadership and the Floor.
• Review, correction and close out of area specific batch records within expected release timeframe.
• Maintain documentation and CGMP standards.
• Communicates effectively with area leadership and cross functional groups.
• Identifies deviations in real time and documents issues in the QMS.

Skills

Aseptic Process SME

FDA CGMP

Servant Leader

Leadership

Emotional IQ

Education

Bachelor Degree

Job description

Glenmark Pharmaceuticals Inc. in Monroe, NC, seeks an experienced Aseptic Manufacturing Manager to lead a team of production supervisors, team leads and technicians responsible for aseptic processing and sterile liquids manufacturing. This role ensures CGMP compliance and acts as a liaison between site leadership and the floor.

The position emphasizes batch record ownership, process optimization, and a strong quality mindset to sustain audit readiness and timely production schedules.