Job Title: Quality Manager
Reports to (Title): VP, Quality Location: Guaynabo, Puerto Rico
I. Department Overview:
The Quality Department is responsible for creating/maintaining the Quality Management System (QMS) for the
Guaynabo facility. The Quality Management System includes Documentation Control, Investigation and Corrective Actions Management, Training, Internal/External Audits, Customer Correspondence, Validation, and also includes QA of the Operation such as process monitoring and batch record review and release.
The Quality Manager is responsible for all regulatory and quality assurance functions at the Guaynabo facility. He/She will lead a team of QA Auditors and will carry the responsibility of ensuring that the day-to-day Quality function is consistently executed. According, the Quality Manager will ensure that Quality systems are employed, improved, and harmonized across the facility and are in line with corporate guidelines to effect consistent execution. The Quality Manager will drive a culture of continuous improvement to ensure that Quality is “built into” rather than “inspected into” the Operation.
• Leads the implementation of Corporate Quality Policies through the development and improvement of site-wide Quality procedures, and drives improvement of Quality Systems to ensure that customer and regulatory agency requirements are consistently met.
• In partnership with the Director of Operations and Production Managers, leads a continuous improvement activity to ensure an efficient and compliant process. Manages a real-time batch record review process.
• Leads and manages all customer related audits and regulatory inspections.
• Defines standard processes and systems with the objective of building Quality into the manufacturing process.
• Responsible for the leadership and development of the Quality Assurance team and includes talent development and overall management.
• Has primary responsibility for managing Quality metrics per Corporate guidelines.
• Presents quality metrics and improvement plans at weekly management meetings and as required.
• Counsels senior management on the regulatory demands which impact achievements of appropriate quality and compliance standards.
• Has critical decision-making authority in the handling of regulatory agency, customer representatives and batch release.
• Responsible for the annual budget setting for the QA organization within the scope of responsibility.
• Holds employees accountable for safety, Quality, throughput, and cost performance.
• 4-year undergraduate BS degree
• Minimum of 5 years of management/supervisory experience required
• Expert level knowledge of FDA cGMP’s preferred .
• Basic knowledge of Lean Six Sigma preferred
• Experience in Pharmaceutical industry preferred
• Proven track record of improving quality, efficiency, and workflow in a production environment
• Personal/Professional development history
• Strong communication skills – written and verbal with bilingual skills (English & Spanish)
• Customer interaction
• Good computer skills, knowledge of MS office