Manager, Document Control

Paragon Gene Therapy, now a part of Catalent, hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives.

Paragon Gene Therapy, in Harmans, Baltimore, Gaithersburg & Rockville, Maryland, provides industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses.

This Document Control Leader will be responsible for the overall leadership of the document control functions within the Quality Assurance group at Harmans. This individual manages the life cycle of controlled documents ensuring regulatory requirements are met and leading operational excellence and continuous improvement initiatives. The Document Control function supports both GMP and development operations.

Key Responsibilities include but are not limited to:

• Provide strategic oversight of the document control systems ensuring phase appropriate processes to support Phase I/II operations with the ability to scale to support Phase III/commercial operations.

• Manages document control processes and systems for GMP activities in compliance with internal procedures and policies, as well as, regulatory requirements.

• Establishes and maintains the lifecycle of controlled documents, including but not limited to: records management systems including version control, document distribution, archival, retrieval, retention and destruction.

• Define resource requirements, plan and prioritize resources, and manage personnel in daily duties and responsibilities based upon business and compliance requirements.

• Responsible for staffing, professional development of employees, and conducting performance reviews within group.

• Responsible for implementation, management, and enhancements of an electronic Document Management System (eDMS).

• Maintains document templates, project tracking, and databases through standard electronic formats.

• Continuous reviews of all systems and procedures (SOPs) for efficiency and regulatory compliance improvements.

• Leads and identifies continuous improvement initiatives.

• Contributes to the overall management of client specific documentation.

Experience & Education:

• Bachelor's or Master's degree in a Life Science field.

• 10 years of relevant experience within the life sciences industry, preferably biotechnology or pharmaceuticals, performing within a Quality Assurance role with some or all of that time responsible for Document Control activities.

• Thorough knowledge of cGMP regulations, quality systems and regulatory requirements.

• 2+ years of direct management experience • Proficiency with electronic management systems (such as QDMS, LMS, EDMS, and E-Doc).

• Advanced skills with MS Office applications and Adobe Acrobat.

Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

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