Manager, QA

Germer International; Upper Dublin Township (PA); On-site; USD 120,000 - 160,000; Full time

Job summary

Germer International seeks a Manager, QA Operations to lead day-to-day QA activities supporting GMP manufacturing, testing, and supply chain processes. The role ensures regulatory compliance and client expectations while driving inspection readiness and continuous improvement.

Lead QA staff and coordinate across functions for timely product disposition and manufacturing support. Responsibilities include supervising batch record review, deviations, CAPAs, changes controls, and product

Qualifications

• Bachelor's degree in a scientific discipline or related field.
• 6-8 years of Quality Assurance experience within the pharmaceutical or biopharmaceutical industry.
• 2-5 years of supervisory or management experience preferred.
• Working knowledge of cGMP, FDA, EMA, and ICH regulations.
• Experience supporting regulatory inspections and customer audits.
• Experience with deviation investigations, CAPAs, change controls, batch record review, and product disposition.
• Experience with electronic quality systems such as Veeva, LabWare LIMS, SAP, or similar platforms preferred.
• Strong organizational, communication, and problem-solving skills with the ability to prioritize multiple activities in a fast-paced GMP environment.

Responsibilities

• Critically review documentation to ensure completeness, accuracy and compliance.
• Apply current GMP regulations and company procedures to QA operations and guide operational teams.
• Participate in cross-functional projects to improve quality systems, operational efficiency, and regulatory compliance.
• Collect and analyze data to identify trends and detect problems and key issues.
• Support the development and maintenance of training programs and competency assessments.
• Manage day-to-day QA Manufacturing and QA Testing operations, including batch record review and material disposition.
• QA support to the CBM Supply Chain end-to-end materials management program.
• Interact with quality team and stakeholders to support release of manufacturing products.
• Promote a culture of quality by reinforcing compliance and continuous improvement.
• Supervise, coach, and develop QA personnel across Manufacturing, QC, Supply Chain, and MSAT teams.

Skills

Leadership

Quality Assurance

Data analysis

Regulatory compliance

Cross-functional

Problem solving

Education

Bachelor's degree in science

Tools

Veeva

LabWare LIMS

SAP

Job description

Position Summary:

The Manager, QA Operations is responsible for the day-to-day management of Quality Assurance Operations supporting GMP manufacturing, testing, and supply chain activities. This role ensures compliance with regulatory requirements, internal procedures, and client expectations while supporting operational excellence, inspection readiness, and continuous improvement initiatives. The Manager provides leadership to QA staff and collaborates cross-functionally to support timely product disposition and manufacturing operations.

Primary Responsibilities:

• Critically review various documentation types to ensure completeness, accuracy and compliance including but not limited to test methods, batch records, change controls and standard operating procedures
• Apply current GMP regulations and company procedures to ensure compliant execution of QA operations and provide guidance to operational teams.
• Participate in cross-functional projects focused on improving quality systems, operational efficiency, and regulatory compliance.
• Judgement and problem solving - able to collect and analyze data to identify trends and detect problems and key issues.
• Support the development and maintenance of training programs and competency assessments to ensure personnel maintain technical and regulatory proficiency.
• Manage the day-to-day activities of QA Manufacturing and QA Testing Operations, ensuring timely execution of batch record review, on-the-floor QA support, material disposition, deviation investigations, CAPAs, change controls, and customer quality support.
• QA support to the CBM Supply Chain end-to end materials management program, including processing of supplier complaints, material receipt and release, inventory control, shipping, and distribution.
• Interact with the quality team and internal stakeholders to support the development, manufacturing, testing, packaging, and release of manufacturing products as needed
• Promote a culture of quality by reinforcing compliance, risk-based decision making, and continuous improvement throughout daily operations.
• Supervise, coach, and develop QA personnel while fostering collaboration with Manufacturing, QC, Supply Chain, and MSAT teams.

Education, Experience, and Qualifications:

• Bachelor's degree in a scientific discipline or related field required.
• 6-8 years of Quality Assurance experience within the pharmaceutical or biopharmaceutical industry.
• 2-5 years of supervisory or management experience preferred.
• Working knowledge of cGMP, FDA, EMA, and ICH regulations.
• Experience supporting regulatory inspections and customer audits.
• Experience with deviation investigations, CAPAs, change controls, batch record review, and product disposition.
• Experience with electronic quality systems such as Veeva, LabWare LIMS, SAP, or similar platforms preferred.
• Strong organizational, communication, and problem-solving skills with the ability to prioritize multiple activities in a fast-paced GMP environment.