QA MANAGER

Job Description

Job Description

The Quality Assurance Systems Manager is responsible for developing, implementing, maintaining, and continuously improving the Quality Management System (QMS) to ensure compliance with applicable regulatory requirements and industry standards. This role oversees quality systems, supports manufacturing and quality operations, manages quality documentation, and partners with cross-functional teams to promote a culture of quality and continuous improvement.

Salary: 90k - 110k a year

Location: Boca Raton, FL

Education & Experience

• Bachelor's degree in Biology, Chemistry, Pharmacy, or a related scientific discipline preferred.
• Minimum of seven (7) years of experience in pharmaceutical manufacturing, quality assurance, or another FDA-regulated healthcare environment.
• Equivalent combinations of education and relevant quality assurance experience may be considered.
• Minimum of three (3) years of supervisory or leadership experience.
• Strong knowledge of current Good Manufacturing Practices (cGMP), FDA regulations, and quality systems.
• Experience with electronic Quality Management Systems (eQMS), such as MasterControl or similar platforms.
• Proficiency in Microsoft Office Suite and Adobe Acrobat.
• Excellent written, verbal, analytical, organizational, and presentation skills.
• Demonstrated ability to manage multiple priorities, lead teams, and drive process improvements.

Key Responsibilities

• Oversee the Quality Management System (QMS) and ensure ongoing compliance with applicable regulatory requirements and internal quality standards.
• Review and approve quality documentation, including batch records, laboratory data, Certificates of Analysis, specifications, and other GMP-related records.
• Manage quality systems including:
• Change Control
• Document Control
• Standard Operating Procedures (SOPs)
• Master Batch Records
• Deviations
• Investigations
• Corrective and Preventive Actions (CAPA)
• Nonconformances
• Customer Complaints
• Supplier Qualification
• Audits
• Calibration
• Sample and Document Retention
• Monitor quality metrics, identify trends, and provide management with reports and recommendations for continuous improvement.
• Support new product introductions, process improvements, validation activities, and engineering changes while ensuring compliance with regulatory requirements.
• Participate in internal, customer, and regulatory inspections, including FDA and other regulatory agency audits, and assist in preparing responses to audit observations.
• Develop, revise, review, and approve quality policies, procedures, forms, and controlled documents.
• Collaborate with Regulatory Affairs, Manufacturing, Engineering, Laboratory, and other departments to ensure compliance with current regulations and quality standards.
• Lead implementation, maintenance, and continuous improvement of electronic Quality Management Systems (eQMS), including document control, training management, change control, investigations, CAPA, deviations, and quality metrics.
• Ensure quality personnel are properly trained and qualified to perform assigned responsibilities.
• Coordinate and oversee GMP and quality-related training programs.
• Supervise, mentor, and develop Quality Assurance staff while assigning work and monitoring performance.
• Promote a culture of quality, compliance, accountability, and continuous improvement throughout the organization.

Knowledge, Skills & Abilities

• Thorough understanding of FDA regulations, cGMP requirements, and pharmaceutical quality systems.
• Strong leadership and team management skills.
• Excellent problem-solving, critical thinking, and decision-making abilities.
• Ability to interpret technical and regulatory documentation.
• Effective communication and presentation skills.
• Strong organizational and project management capabilities.
• Ability to manage multiple priorities in a fast-paced, regulated environment.
• Experience with quality data analysis, trend reporting, and risk-based decision making.

Physical Requirements

• Ability to work a flexible schedule as needed to support business operations.
• Ability to wear required personal protective equipment (PPE), including gowning, hearing protection, and respiratory protection where applicable.
• Ability to sit, stand, and walk for extended periods throughout the workday.
• Correctable vision sufficient to perform job duties.
• Ability to lift and carry up to 35 pounds as needed.

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