Quality Assurance Operations Manager
4 days ago
Job Summary
Civica is seeking a highly experienced Quality Assurance Operations Manager to lead our sterile injectables quality assurance team. As a key member of our operations team, you will be responsible for ensuring the highest level of quality and compliance in our manufacturing processes.
Key Responsibilities
- Provide leadership and direction to the quality assurance team to ensure they are qualified, motivated, and carry out their duties in a safe manner.
- Maintain current knowledge of regulatory and legislative requirements and trends to ensure expert advice and technical support on quality-related matters.
- Ensure procedural documents, manufacturing batch records, and processes are in accordance with FDA regulations and GMPs.
- Approve raw materials, excipients, APIs, and component material qualifications.
- Ensure all components, raw materials, excipients, drug product containers, closures, in-process materials, packaging material, labeling, and drug products are released in accordance with registered specifications.
- Lead quality shop-floor oversight, including real-time batch record review, response to deviations, and implementation of corrective actions.
- Manage labeling processes and disposition of drug products.
- Support quality processes and systems across the product lifecycle, including change control, CAPA, deviations, and investigations.
- Participate in quality risk analysis and process transfers.
- Proactively identify and resolve problems using risk-based and compliant approaches.
- Promote a quality mindset and quality excellence approach to all activities.
- Promote a safety mindset and focus on safety for all operations activities.
Requirements
- 8+ years of experience working directly with manufacturing in sterile injectable pharmaceutical and packaging operations.
- Bachelor-level or higher education.
- Project management, organization, and execution skills.
- Ability to apply technical expertise to solve problems and issues.
- Experience with technology transfers and new product introduction.
- Knowledge of data integrity controls in a manufacturing setting.
- Participation and leading activities to support regulatory agency inspections.
- Minimum of 3 years of experience in a supervisory role.
- Excellent interpersonal and written communication skills and experience using various software/electronic applications.
- Self-motivated, flexible, and able to work in a small, fast-paced, dynamic environment.
- Ability to work autonomously and within established guidelines, procedures, and practices.
Preferred Qualifications
- Experience in Drug Enforcement Agency requirements for the handling and distribution of controlled substances.
- Experience with isolator technology.
- Experience with combination products.
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