Senior Quality Manager

2 days ago


New Castle, Delaware, United States Liveo Research Full time
Senior Quality Manager Job Description

Liveo Research is seeking a highly skilled Senior Quality Manager to join our team in Delaware City, Delaware. As a Senior Quality Manager, you will be responsible for leading the quality department and ensuring adherence to regulatory and legal requirements.

Key Responsibilities:
  • Develop and implement quality strategies to ensure compliance with cGMP standards and customer expectations.
  • Direct quality department operations, including monitoring, reviewing, and improving systems and processes.
  • Provide guidance and support to ensure adherence to regulatory and legal requirements.
  • Oversee employee performance, training, and career development.
  • Develop and train best laboratory practices to meet global pharma customer standards.
  • Expand and improve processes and systems to minimize complaints and nonconformities.
  • Coordinate the review and update of SOPs, policies, and processes.
  • Lead investigations and analysis of quality complaints and implement corrective action.
  • Assist with execution of validation protocols and equipment qualifications.
  • Review technical problems, procedures, complaints, and non-conformance of departments, materials, and processes.
  • Review and approve batch records, Change Orders, Contingency Deviation Reports, Manufacturing Instructions, and Component Specification Sheets.
  • Lead audits, including internal audits, supplier audits, QA and packaging audits, and research projects.
  • Work with other Liveo Sites to establish global uniformity with quality systems.
  • Review regulatory publications to stay up-to-date on new quality developments.
  • Collaborate with other departments and management to set safety standards.
  • Manage the Quality Budget.
  • Identify areas of capital investment required to upgrade systems and infrastructure.
Requirements:
  • Bachelor's Degree in science or equivalent in pharmacy or related field.
  • 7 years in pharmaceutical or biotech manufacturing in a Quality role.
  • Demonstrated ability to work independently, handle multiple tasks simultaneously, and negotiate and meet critical timelines.
  • Excellent oral and written communication skills.
  • Proficient with interpreting and implementing cGMPs, FDA standards, and CFRs.
  • Strong leadership to mentor and develop team to achieve Company goals.
  • Strong working knowledge of personal computers and Microsoft Office Products.
Equal Opportunity Employer:

Liveo Research is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, genetic information, or any other characteristic protected by law.



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