Associate Director, Document Control & Training

Electra Therapeutics, based in South San Francisco, California, is a clinical stage biotechnology company developing therapies that target signal regulatory proteins (SIRP) for the treatment of immunological diseases and cancer.

The Associate Director, Document Control and Training will report to the Head of Quality and will be responsible for managing the document control system, ensuring compliance with regulatory requirements, and overseeing the development and execution of training programs. The ideal candidate will have a strong background in document management, quality systems, and training within the biotech or pharmaceutical industry, as well as a demonstrated ability to work in a fast-paced, collaborative environment.

RESPONSIBILITIES:

• Lead and manage the GxP Document Control and Training team, overseeing the creation, approval, and maintenance of controlled documents (Policies, SOPs, Work Instructions, protocols, reports, etc.).
• Ensure compliance with internal formatting standards and regulatory requirements (GxP includes but is not limited to GCP, GCLP, GVP, GLP and CGMP).
• Process GxP controlled documents within the eDMS, working closely with functional areas to route new and revised documents and retire existing documents through the review and approval process.
• Collaborate with department managers to develop GxP training requirements and plans (Read and Understand, On-the-Job, Instructor-Led training).
• Works as the Business Owner on the eDMS and LMS validation teams to configure and validate the eDMS and eLMS.
• Works with IT to maintain the eDMS and eLMS validation status through IT change control
• Assist with QA management and validation teams to file GxP Computerized Systems validation records.
• Maintain GxP training records and matrices and oversee electronic systems for document and training management (eDMS, eLMS).
• Facilitate GxP training curricula development and delivery to GxP personnel, including but not limited to documentation practices.
• Manage the execution of daily tasks in document control and training.
• Generate compliance metrics, and prepare KPI reports related to GxP Document Management and GxP Training compliance.
• Drive continuous improvement in document control, training processes, and electronic quality systems.
• Foster cross-departmental collaboration and ensure quality process consistency across the organization.
• Works with QA management to maintain the QA Files in SharePoint.

 EDCUATION & PROFESSIONAL EXPERIENCE:

• Bachelor’s degree in Computer Science, Life Science or related field or applicable experience
• A minimum of 5 years of relevant experience in the pharmaceutical/biotechnology industry
• Strong knowledge of electronic systems (eDMS and eLMS) and experience with document management and training systems.
• Proven experience with system validation, electronic records, and managing compliance metrics.
• Proficiency in Microsoft Office Suite and other desktop applications, with the ability to manage multiple projects in a fast-paced environment.
• Excellent communication, organizational, and leadership skills with the ability to engage across all levels of the organization.

The salary range for this position is $170,000 - $190,000. Base salary compensation is determined by a range of factors, including but not limited to candidate experience, qualifications, location and more.