Senior Quality Manager

4 days ago

New Castle, United States Liveo Research Full time

Senior Quality Manager

WHY DO YOU WANT TO WORK AT LIVEO RESEARCH?

  • Career stability and opportunities for advancement
  • Complete Benefit Package, medical, dental, vision, 401K with company match, Short Term Disability, Employee Life
  • Generous 401K Match

Liveo Research is a global manufacturer of rigid packaging solutions with five locations worldwide. Our pharmaceutical manufacturing plant in Delaware City, Delaware is looking for a Senior Quality Manager.

Do you have experience in pharma, compliance as it relates to prevention and elimination in deviations in procedures, packaging materials, developing and maintaining process improvement objectives, well then we have a position for you. Come join our team

What you will do:

  • Develop departmental strategy and vision to ensure adherence with management and customer expectations.
  • Direct quality department operations: monitor, review and improve systems and processes to ensure compliance with core quality measures.
  • Provide support and guidance to ensure adherence to regulatory and legal requirements by analysing and improve quality system and product quality assurance and controls.
  • Oversee, motivate, mentor, and evaluate the Quality Departments employee performance, training and career development.
  • Develop and train best laboratory practices to meet global pharma customer standards.
  • Expand and improve the processes and systems to minimize complaints and nonconformities.
  • Coordinate the review and update of SOPs, policies and processes regularly to ensure all quality standards are in compliance with global cGMP standards and all competent authority regulations and requirements, for supply of quality packaging material for pharmaceutical products.
  • Oversee the analyization and review of the quality control tests, quality control documents, batch records and release of the conforming materials to ensure release in a timely manner.
  • Lead investigations and analysis of quality complaints and implement corrective action and preventive plan to ensure its effectiveness.
  • 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 (pre-execution) batch records, Change Orders, Contingency Deviation Reports, Manufacturing Instructions and Component Specification Sheets to ensure proper quality and compliance standards are met.
  • Review batch record templates and initiate modifications when necessary.
  • Lead audits, including internal audits , supplier audits, QA and packaging audits, and research projects as per the standard system.
  • Work with other Liveo Sites to establish global uniformity with quality systems.
  • Review regulatory publications to keep apprised of 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 the systems and infrastructure to meet the customer demands on quality and GMP and work with team and management to implement the same.
  • Promote communication among the team by leading regular meetings with pertinent updates and other developmental activities.
  • Adhere to set safety standards.

To set you up for success in this role from day one, Liveo is looking for candidates who must have the following qualifications:

  • Bachelors Degree in science or equivalent in pharmacy or related field.
  • 7 years in pharmaceutical or biotech manufacturing in a Quality .
  • Demonstrated ability to work independently, handle multiple tasks simultaneously and negotiate and meet critical timelines.
  • Excellent oral and written communication is required to communicate with the team, peers, management and external contacts.
  • 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, including Word, Project and Excel.

General Employment Requirements
Background Check required
Drug Testing required

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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