Senior Quality Manager

2 weeks ago

Salem, New Jersey, 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 key member of our quality department, you will be responsible for ensuring the highest standards of quality and compliance in our pharmaceutical manufacturing plant.

Key Responsibilities:
  • Develop and implement quality strategies to meet customer expectations and regulatory requirements.
  • Lead the quality department in monitoring, reviewing, and improving systems and processes to ensure compliance with core quality measures.
  • Provide guidance and support to ensure adherence to regulatory and legal requirements by analyzing and improving quality systems and product quality assurance and controls.
  • Oversee the performance, training, and career development of quality department employees.
  • 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 regularly to ensure all quality standards are in compliance with global cGMP standards and all competent authority regulations and requirements.
  • Oversee the analysis and review of quality control tests, quality control documents, batch records, and release of conforming materials to ensure timely release.
  • Lead investigations and analysis of quality complaints and implement corrective action and preventive plans to ensure their effectiveness.
  • Assist with the execution of validation protocols and equipment qualifications.
  • Review technical problems, procedures, complaints, and non-conformances of departments, materials, and processes.
  • Review and approve 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 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 to meet customer demands on quality and GMP and work with the team and management to implement the same.
  • Promote communication among the team by leading regular meetings with pertinent updates and other developmental activities.
Requirements:
  • Bachelor's degree in science or equivalent in pharmacy or related field.
  • 7 years of experience 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 to communicate with the team, peers, management, and external contacts.
  • Proficient in interpreting and implementing cGMPs, FDA standards, and CFRs.
  • Strong leadership to mentor and develop the team to achieve company goals.
  • Strong working knowledge of personal computers and Microsoft Office products, including Word, Project, and Excel.

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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