Manager, Quality Assurance

Curia • Springfield, MO

30d • Onsite

About The Position

The Quality Assurance Manager plays a key role in ensuring products are manufactured in accordance with Curia’s quality systems, regulatory requirements, and customer expectations. This role partners closely with the Director, Quality Assurance and cross-functional teams to implement and continuously improve quality processes, including in-process and final product inspections, ensuring materials consistently meet defined standards for safety, reliability, and performance. The Quality Assurance Manager helps drive a culture of accountability and quality across the site by strengthening systems, addressing issues with urgency, and ensuring teams are equipped to deliver high-quality outcomes every day.

Requirements

• Bachelor of Science in Chemistry or a related field plus five years’ experience in pharmaceuticals or a related industry
• Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.
• Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
• Ability to write speeches and articles for publication that conform to prescribed style and format.
• Ability to effectively present information to top management, public groups, and/or boards of directors.
• Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry.
• Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
• Expert level of understanding of US FDA regulations and cGMP.
• Ensure site personnel perform all documentation in compliance with ALCOA and good documentation practices as defined by site SOP’s.
• Oversee and monitor performance of staff to ensure compliance with all cGMP SOP’s.
• Review cGMP related documentation to ensure Good Documentation Practices have been adhered to.
• Strict compliance with all cGMP documents SOP’s, Batch records, protocols, change controls, controlled forms, etc.
• Ensure all cGMP applicable training is kept current for yourself and subordinates
• Provide training and guidance to staff and site personnel as needed on site SOP’s, Batch records, protocols, change controls, controlled forms, etc.
• Ensure staff have appropriate training documented prior to assigning work.
• Escalate any quality concerns and proposed compliant solutions to the Quality department.
• Perform job functions in compliance with applicable US FDA regulations and current Good Manufacturing Practices.

Nice To Haves

• Other duties may be assigned.
• Other Qualifications

Responsibilities

• Lead Quality with Accountability and Integrity
• Partner with the Site Quality Head to strengthen and sustain the site Quality Assurance program.
• Own batch review and product disposition decisions, ensuring compliance with internal standards and regulatory requirements.
• Make sound, timely decisions that protect product quality and patient safety.
• Drive Compliance Through Strong Systems
• Develop and continuously improve quality standards, procedures, and systems that support manufacturing and support functions.
• Ensure effective document and change control processes, with clear and compliant implementation across the site.
• Maintain inspection readiness by ensuring quality records and systems are accurate, complete, and audit-ready.
• Approach Problems with Curiosity and Rigor
• Lead investigations into deviations, complaints, and quality events to identify true root cause.
• Analyze quality trends and identify opportunities to reduce defects and improve performance.
• Implement corrective and preventive actions that are effective, timely, and sustainable.
• Act with Urgency in Audits and Quality Events
• Lead customer audits and regulatory inspections, including preparation, hosting, and response management.
• Conduct internal audits and ensure findings are addressed quickly and effectively.
• Drive timely closure of audit observations and CAPAs.
• Build Partnerships Through Respect and Collaboration
• Work closely with Production, Quality Control, Regulatory, and other functions to resolve quality issues and improve processes.
• Support vendor qualification and inspection activities.
• Communicate clearly and constructively to align teams around quality expectations.
• Strengthen Capability and Quality Culture
• Ensure employees are trained and confident in applying Curia standards, procedures, and cGMP requirements.
• Reinforce a culture where quality, safety, and accountability are part of everyday work.
• Support Validation and Continuous Improvement
• Support validation activities for methods, equipment, and facilities (IQ, OQ, PQ).
• Recommend improvements to systems, equipment, and processes to enhance quality and reliability.
• Safety and Additional Responsibilities
• Promote safe work practices and ensure safety remains a priority in all activities.
• Support additional quality and site initiatives as needed.
• Good Manufacturing Practices & Good Documentation Practices
• Ensure staff are knowledgeable in US FDA regulations & cGMP requirements to perform their job function.
• Ensure site personnel perform all documentation in compliance with ALCOA and good documentation practices as defined by site SOP’s.
• Oversee and monitor performance of staff to ensure compliance with all cGMP SOP’s.
• Review cGMP related documentation to ensure Good Documentation Practices have been adhered to.
• Strict compliance with all cGMP documents SOP’s, Batch records, protocols, change controls, controlled forms, etc.
• Ensure all cGMP applicable training is kept current for yourself and subordinates
• Provide training and guidance to staff and site personnel as needed on site SOP’s, Batch records, protocols, change controls, controlled forms, etc.
• Ensure staff have appropriate training documented prior to assigning work.
• Escalate any quality concerns and proposed compliant solutions to the Quality department.
• Perform job functions in compliance with applicable US FDA regulations and current Good Manufacturing Practices.
• Other Qualifications
• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening

Benefits

• Generous benefit options (eligible first day of employment)
• Paid training, vacation and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities
• Education reimbursement
• 401K program with matching contributions
• Learning platform
• And more!

What This Job Offers

• Job Type: Full-time
• Career Level: Manager