Quality Operations Manager

Germer International - Pharmaceutical Recruiting; Malvern (Chester County); On-site; USD 120,000 - 170,000; Full time

Job summary

Germer International - Pharmaceutical Recruiting is seeking a Manager, QA Operations to lead day-to-day QA operations supporting GMP manufacturing, testing, and supply chain activities in the United States. You will ensure compliance with regulatory requirements and client expectations while driving inspection readiness and continuous improvement.

The role requires a Bachelor's in a scientific field, 6–8 years QA experience in pharma/biopharma, and 2–5 years of supervisory experience.

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.

Responsibilities

• Critically review documentation such as test methods, batch records, change controls and SOPs for completeness, accuracy and compliance.
• Apply current GMP regulations to ensure compliant execution of QA operations and provide guidance to teams.
• Participate in cross-functional projects to improve quality systems, efficiency, and regulatory compliance.
• Support development and maintenance of training programs and competency assessments.
• Manage day-to-day QA Manufacturing and QA Testing Operations, including batch record review, on-the-floor QA support, material disposition, deviation investigations, CAPAs, change controls, and customer quality support.
• Interact with quality team and stakeholders to support development, manufacturing, testing, packaging, and release of products.
• Promote a culture of quality through compliance, risk-based decisions, and continuous improvement.

Skills

GMP knowledge

Regulatory compliance

Quality oversight

Leadership

Education

Bachelor's degree in a scientific discipline

Tools

Veeva

LabWare LIMS

SAP

Job description

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.

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.
• 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.
• 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.

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.