What are the responsibilities and job description for the Manufacturing Operations & Validation Manager position at Katalyst HealthCares & Life Sciences?
Responsibilities
- Ensure that all finished products are manufactured, packaged, and labeled in compliance with legal and regulatory requirements.
- Ensure raw materials, components, in-process materials, and finished products meet quality and regulatory specifications.
- Collaborate with QA teams to ensure manufacturing processes align with the company's Quality Management System (QMS).
- Oversee the validation of manufacturing equipment, systems, and processes to ensure compliance with FDA 21 CFR Part 820, ISO 13485, and GMP guidelines.
- Lead qualification of new equipment, ensuring adherence to Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
- Ensure software and IT system validation for Manufacturing Execution Systems (MES) and Enterprise Resource Planning (ERP) systems.
- Develop and implement validation plans, protocols, and reports, ensuring they meet regulatory standards and company policies.
- Identify and implement process validation (PV) strategies to enhance efficiency, quality, and compliance in manufacturing.
- Oversee re-validation activities when process or equipment changes occur to maintain compliance.
- Lead Corrective and Preventive Actions (CAPA) by addressing deviations, conducting root cause analyses, and ensuring timely resolution of issues.
- Manage validation documentation, including protocols, reports, and Standard Operating Procedures (SOPs), in accordance with regulatory requirements.
- Lead and manage onshore and offshore teams, ensuring they are well-trained, motivated, and aligned with company goals.
- Provide mentorship and guidance to manufacturing and validation teams, fostering a culture of compliance and operational excellence.
- Work with training departments to ensure that teams receive proper training on procedures, regulatory compliance, and equipment handling.
- Bachelor's degree in engineering (Mechanical, Chemical, Industrial), Manufacturing, Life Sciences, or a related field.
- 510 years of experience in quality, manufacturing operations, and validation in a regulated industry (pharmaceuticals, medical devices, or food manufacturing).
- 38 years of leadership experience, with the ability to manage onshore and offshore teams.
- Strong understanding of regulatory requirements including FDA 21 CFR Part 820, GMP, and ISO 13485.
- Experience in process validation (PV), equipment qualification (IQ, OQ, PQ), and software validation.
- Ability to lead cross-functional teams, interact with senior management, and liaise with regulators or auditors.
- Strong analytical, problem-solving, and continuous improvement mindset.
- Excellent communication and leadership skills to manage teams and drive compliance.
- Manufacturing operations, validation (IQ, OQ, PQ, PV), regulatory compliance (FDA, GMP, ISO).
- Pharmaceuticals, medical devices, food manufacturing.
- Leadership, problem-solving, cross-functional collaboration, regulatory communication.
- MES, ERP, quality management systems (QMS), validation documentation tools.
