Manufacturing Operations & Validation Manager

Apply Now

Company: Katalyst HealthCares and Life Sciences

Location: Richmond, VA 23223

Description:

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.
Requirements:
  • Bachelor's degree in engineering (Mechanical, Chemical, Industrial), Manufacturing, Life Sciences, or a related field.
  • 5-10 years of experience in quality, manufacturing operations, and validation in a regulated industry (pharmaceuticals, medical devices, or food manufacturing).
  • 3-8 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.
  • bility 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.

Similar Jobs