Quality Manager – Documentation and Training Management

We are seeking a highly motivated individual to join the BlueRock team as a Quality Manager – Documentation and Training Management in the Quality Assurance (QA) department reporting to the Director of Quality Systems and Technology. This position will be responsible for ensuring that all documents are accurate, complete, and adhere to industry regulations and company policies.

This position plays a key role in maintaining the documentation systems, training systems, supporting audits, and facilitating the processing of documentation and training across various departments. This position will assist implementing and managing the training program. The position will work with a diverse group of partners to provide a continuously improving, controlled, compliant and effective documentation and training program.

Responsibilities:

• Develop, implement, and maintain documentation standards, policies, and procedures ensuring adherence to regulatory requirements.
• Oversee the creation, revision, and distribution of all controlled documents, including SOPs, batch records, protocols, and reports.
• Design and deliver comprehensive training programs, including onboarding and job-specific training
• Conduct regular assessments to identify training needs and gaps.
• Create and update training materials, manuals, and e-learning modules.
• Train staff in the use of document control and training systems and ensure adherence to document control procedures and training requirements.
• Manage the lifecycle of documents from creation through archival, ensuring appropriate version control and access management.
• Work cross-functionally to facilitate the documentation of processes, product information, and data.
• Act as a liaison between departments to ensure seamless documentation flow and resolve any documentation issues.
• Mentor and develop documentation staff, fostering a culture of quality and compliance.
• Identify opportunities for improving documentation and training processes and systems.
• Participate in internal and external audits, providing documentation support and ensuring timely responses to audit findings.
• Drive the implementation of best practices in documentation and learning management.

Minimum Requirements:

• Life Sciences based Bachelor’s degree with 11+ Years relevant industry experience in C>, pharma, biopharma, biotech with demonstrated knowledge of relevant cGMP regulations. Advanced degrees with less years of relevant experience will be considered.
• Proficiency in using electronic document management systems (EDMS) and learning management systems (LMS), preferably Veeva
• Proficiency in development and delivery of training content
• Excellent organizational and project management skills.
• Attention to detail and a high level of accuracy
• Seeking a highly adaptable and skilled problem solver with a proactive attitude comfortable with ambiguity
• Skills with influencing and negotiating with stakeholders of various levels is highly desirable
• Experience in Cell & Gene Therapy or Sterile Large Molecule Biologics preferred

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