About the Role: We are seeking an experienced Project Manager with a strong background in the pharmaceutical industry, particularly in validation and change control. The ideal candidate will be responsible for managing and coordinating multiple projects while ensuring compliance with regulatory requirements and industry best practices.

Key Responsibilities:

• Oversee the planning, execution, and completion of validation and change control projects.
  
• Develop and implement project plans, timelines, and resource allocation strategies.
  
• Ensure compliance with GxP regulations, FDA, EMA, and other industry standards.
  
• Manage change control processes, ensuring that all modifications are assessed, approved, and documented properly.
  
• Coordinate with cross-functional teams, including Quality Assurance (QA), Regulatory Affairs, Manufacturing, and Engineering.
  
• Monitor project progress, identify risks, and implement mitigation strategies.
  
• Prepare and present project status reports to stakeholders and senior management.
  
• Facilitate validation activities, including IQ, OQ, PQ, and process validation.
  
• Maintain documentation and ensure audit readiness.
  

Qualifications & Experience:

• Bachelor’s/Master’s degree in Pharmaceutical Sciences, Engineering, Life Sciences, or a related field.
  
• Minimum 5-7 years of project management experience in the pharmaceutical industry.
  
• Strong knowledge of validation (process, cleaning, equipment, and computer systems validation).
  
• Experience with change control management systems and regulatory compliance.
  
• Familiarity with GMP, FDA, EU regulations, and ICH guidelines.
  
• Proficiency in project management tools (MS Project, Jira, Smartsheet, etc.).
  
• PMP, PRINCE2, or similar certification is a plus.
  
• Strong leadership, communication, and problem-solving skills.
  

Preferred Skills:

• Experience in biotechnology, sterile manufacturing, or medical device industries.
  
• Ability to work in a fast-paced and regulated environment.
  
• Knowledge of risk management and continuous improvement methodologies.