Enzene - Senior Manager, Document & Training Management

About Our Client - Enzene
Enzene Inc. is an emerging Contract Development and Manufacturing Organization (CDMO) with a strong operational footprint in India. We are a subsidiary of Enzene Biosciences, a leading biotechnology company. Our mission is to provide high-quality biologics manufacturing services to our clients, contributing to the advancement of the pharmaceutical industry.

Website: www.enzene.com

Position Overview
The Senior Manager of Document and Training Management will oversee the development, implementation, and maintenance of the document control and training programs within the biologics manufacturing facility. This role ensures compliance with regulatory requirements and company standards, driving continuous improvement in documentation practices and employee training programs.

Key Responsibilities

• Document Management: Collaborate with Global QMS team in developing and maintaining a robust document control system to ensure all manufacturing documents are current, accurate, and compliant with regulatory standards (Human and Animal Health regulations). Oversee the creation, revision, and approval processes for Standard Operating Procedures (SOPs), batch records, and other critical documents. Ensure proper archiving and retrieval of documents to support audits and inspections.
• Training Management: Design and implement comprehensive training programs for new hires and ongoing employee development, focusing on GMP (Good Manufacturing Practices) and other regulatory requirements. Coordinate with department heads to identify training needs and develop customized training modules. Monitor and evaluate the effectiveness of training programs, making adjustments as necessary to improve outcomes.
• Compliance and Audits: Ensure all documentation and training activities comply with FDA, EMA, and other relevant regulatory bodies. Prepare for and participate in internal and external audits, providing necessary documentation and training records. Address audit findings and implement corrective actions to maintain compliance.
• Team Leadership: Lead and mentor a team of document control and training specialists, fostering a culture of continuous improvement and professional development. Set performance goals, conduct regular evaluations, and provide feedback to team members.
• Continuous Improvement: Identify opportunities for process improvements in document control and training management. Implement best practices and innovative solutions to enhance efficiency and compliance.

Requirements

Qualifications

• Education: Bachelor’s degree in Life Sciences, Engineering, or a related field; advanced degree preferred.
• Skills: In-depth knowledge of GMP, FDA, EMA, and other regulatory requirements. Proficiency in document management systems and training software. Strong leadership and team management skills.

• Experience: Minimum of 10 years of experience in document control and training management within the pharmaceutical or biologics manufacturing industry.

• Communication: Excellent communication and interpersonal skills.

Why Join Enzene?
At Enzene, we foster a collaborative and innovative environment where science and business intersect. Our team is dedicated to pushing the boundaries of biosimilar manufacturing, and we are constantly striving to improve processes and patient outcomes. Joining Enzene means being part of a company that values integrity, innovation, and collaboration in pursuit of scientific excellence.

We offer an environment of growth, learning, and opportunity in a sector that is driving change in healthcare.

Equal Opportunity Employer
Enzene is an equal opportunity employer, committed to fostering a diverse and inclusive work environment where all employees can thrive.