Process & Product Manager

Company Description

QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

Log on now to our website http://www.qrcgroup.com/ to learn more about our services and solutions!

Job Description

Lead the end-to-end management of processes and products within a regulated manufacturing environment, ensuring operational efficiency, regulatory compliance, and continuous improvement. Responsible for overseeing the product lifecycle, optimizing production processes, and guaranteeing quality standards in accordance with applicable regulations (ISO, GMP, FDA, etc.).

Key Responsibilities:

• Process Management:

• Design, implement, and optimize manufacturing processes to maximize efficiency, reduce costs, and improve quality.
• Monitor and analyze key performance indicators (KPIs) for production, quality, and compliance.
• Drive continuous improvement initiatives (Lean, Six Sigma, Kaizen).

• Product Management:

• Coordinate product development, launch, and maintenance, ensuring alignment with regulatory and market requirements.
• Collaborate with R&D, Quality, Engineering, and Supply Chain teams to ensure technical and commercial feasibility.

• Regulatory Compliance:

• Ensure processes and products comply with local and international standards (ISO 9001, GMP, FDA, etc.).
• Prepare and maintain technical and regulatory documentation.

• Leadership & Coordination:

• Manage cross-functional teams, fostering a culture of quality and continuous improvement.
• Act as a liaison between operations, quality, and senior management for strategic decision-making.
• Design, implement, and optimize manufacturing processes to maximize efficiency, reduce costs, and improve quality.
• Monitor and analyze key performance indicators (KPIs) for production, quality, and compliance.
• Drive continuous improvement initiatives (Lean, Six Sigma, Kaizen).
• Coordinate product development, launch, and maintenance, ensuring alignment with regulatory and market requirements.
• Collaborate with R&D, Quality, Engineering, and Supply Chain teams to ensure technical and commercial feasibility.
• Ensure processes and products comply with local and international standards (ISO 9001, GMP, FDA, etc.).
• Prepare and maintain technical and regulatory documentation.
• Manage cross-functional teams, fostering a culture of quality and continuous improvement.
• Act as a liaison between operations, quality, and senior management for strategic decision-making.

Qualifications

• Education:
• Bachelor’s degree in Industrial Engineering, Chemical Engineering, Process Engineering, or related fields.
• Experience:
• Minimum 5 years in process and product management within a regulated industry (pharmaceutical, medical devices, etc.).
• Technical Knowledge:
• Regulatory standards (ISO, GMP, FDA).
• Continuous improvement tools (Lean, Six Sigma).
• Project management (PMI certification preferred).
• Skills:
• Leadership, analytical thinking, results-oriented, effective communication.
• Languages:
• Spanish and English (Write/Speak).
• Bachelor’s degree in Industrial Engineering, Chemical Engineering, Process Engineering, or related fields.
• Minimum 5 years in process and product management within a regulated industry (pharmaceutical, medical devices, etc.).
• Regulatory standards (ISO, GMP, FDA).
• Continuous improvement tools (Lean, Six Sigma).
• Project management (PMI certification preferred).
• Leadership, analytical thinking, results-oriented, effective communication.
• Spanish and English (Write/Speak).

Additional Information

All your information will be kept confidential according to EEO guidelines.