We have a current opportunity for a Manager, Quality Systems on a permanent basis. The position will be based in Omaha, NE. For further information about this position please apply.
Responsibilities:
- You will manage Quality Systems Program which includes: Deviations/Corrective and Preventative Actions (CAPA), Change Control, Supplier Qualification, KPI, and Environmental Program.
- You will write, review and/or approve Deviations, Complaints, Quality System Standard Operating Procedures, Change Controls and Specifications.
- You will write, review and/or approve manufacturing instructions and/or batch records.
- You will be responsible for product release activities including batch record review, product disposition, returns, salvages, recalls, product improvement and product annual review.
- You will conduct/assist in investigations of deviations and CAPAs; Out of Specifications (OOS's) for Release/Stability and Out of Trends (OOT's).
- You will be responsible for the oversight of the training program documentation. Provide training as required.
- You will write, review and/or approve OOS, including stability OOS.
Regulatory Compliance:
- Ensure software systems meet relevant regulatory requirements, including FDA regulations (21 CFR Part 11, 820) and other applicable standards (ISO 13485).
- Coordinate and support internal and external audits and inspections related to software quality.
Risk Management:
- Identify, assess, and mitigate software quality risks throughout the product lifecycle.
- Develop risk management strategies and support risk assessments for software changes and updates.
Cross-Functional Collaboration:
- Collaborate with R&D, IT, Regulatory Affairs, and other departments to integrate quality principles into software development and maintenance processes.
- Provide guidance and support for the implementation of software quality initiatives across the organization.
Continuous Improvement:
- Lead efforts to identify areas for process improvement and drive initiatives to enhance software development and quality assurance processes.
- Analyze software quality metrics and trends to make data-driven decisions for process optimization.
Qualifications:
- You will have a Bachelor's degree in a scientific discipline.
- You will have a minimum of five years of experience with FDA and cGMP requirements in a pharmaceutical environment.
- You will have a minimum of five years of experience with Quality Assurance / Quality Control practices in a pharmaceutical environment.
- You will have an advanced understanding of manufacturing in cGMP environment, documentation and data integrity requirements.
- You will have excellent time management and organization skills.
- You will have strong written and verbal communication and employee relation skills.
- You will be proficient in Windows applications (Word, Excel, PowerPoint, Outlook, etc.) and other basic computer skills.
