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.

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