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Quality Assurance Manager

2 months ago

Miami, United States Connect Life Science Full time

Quality Assurance Manager

Miami

Pharma

$120,000


Job Summary:

Our client is seeking a detail-oriented and experienced Quality Assurance (QA) Mid Manager to join the team in Miami, FL. The ideal candidate will have significant experience in Quality Management Systems (QMS), with a strong focus on working with computer systems, implementations, complaints handling, metrics analysis, and quality system management investigations. This role requires a proactive leader who can manage deviations, oversee batch records systems, and ensure compliance with regulatory standards.


Key Responsibilities


Quality Management System (QMS):

  • Lead the management and continuous improvement of the QMS, particularly in areas related to computer systems and their implementation.
  • Ensure that all quality processes are aligned with regulatory standards and company policies.


Computer Systems Implementation:

  • Oversee the implementation and validation of computerized systems within the quality management framework.
  • Collaborate with IT and other departments to ensure that systems meet regulatory and operational requirements.


Complaints Handling:

  • Manage the complaints process, ensuring timely investigation, root cause analysis, and resolution.
  • Develop and maintain systems to track and trend complaints, implementing corrective and preventive actions as needed.


Metrics and Reporting:

  • Develop, track, and analyze key quality metrics to monitor the effectiveness of the QMS.
  • Provide regular reports to senior management, identifying trends, areas for improvement, and progress on quality initiatives.


Investigations and Deviations:

  • Lead and manage investigations into quality issues, deviations, and non-conformances.
  • Ensure thorough documentation and implementation of corrective and preventive actions (CAPAs).


Batch Records Management:

  • Oversee the review and approval of batch records to ensure compliance with GMP regulations.
  • Collaborate with production teams to resolve any issues related to batch documentation.


Compliance and Audits:

  • Prepare for and participate in internal and external audits, ensuring the readiness of all quality systems.
  • Implement audit findings and maintain a state of continual audit readiness.


Qualifications:

  • Education: Bachelor’s degree in a relevant scientific or engineering discipline.
  • Experience: Minimum of 5-7 years of experience in quality assurance within the pharmaceutical industry, with at least 2 years in a supervisory or managerial role.
  • Technical Skills:
  • Extensive experience with QMS, particularly in relation to computerized systems and implementations.
  • Strong knowledge of regulatory requirements (FDA, GMP) and quality standards.
  • Proficient in managing complaints, investigations, deviations, and batch record systems.
  • Experience with quality metrics and data analysis.
  • Leadership Skills: Proven ability to lead, mentor, and develop a team, with strong problem-solving and decision-making capabilities.
  • Communication Skills: Excellent verbal and written communication skills, with the ability to interact effectively with cross-functional teams and senior management.