Associate Director, R&D Quality Assurance

Our Global Gene Therapy client here in Cambridge, MA is looking to on board an AD, R&D QA to their team!  This role will support GLP/GTP/GCLP QA oversight for research & development (R&D) activities required at all stages of the company’s products’ life cycle. In this position, will be actively involved in executing the R&D QA strategy and 21 CFR Part 58 Quality Assurance Unit (QAU) activities by participating in R&D program teams, contributing to risk-based assessments, providing R&D QA support to foster cross-functional partnerships, and implementing regulatory intelligence processes. This role will be involved in review of MAA/BLA submissions, contribute to inspection readiness efforts and Quality Management System (QMS) activities including procedural development, metrics tracking, and other process improvements.  Additionally, the Associate Director, R&D QA will be responsible for ensuring that internal and external audits, deviations, and CAPAs are documented and remediated in a proactive manner in full compliance with internal policies as well as with all applicable regulatory requirements.  Proactive and insightful analytical and management skills are required, including an understanding of how to interpret business requirements, make strategy adjustments when necessary and translate them into efficient processes.  Effective communication, priority management, and compliance management tracking, reporting, and problem solving will be core skillsets for this role.  Responsibilities include: 

 

  • Lead the GLP/GTP/GCLP R&D QA Strategy implementation
  • Provide Quality Assurance Unit support as described in 21 CFR Part 58
  • Represent R&D QA at program team meetings
  • Perform R&D QA risk assessments
  • Build and foster cross-functional partnerships throughout the organization
  • Review MAA/BLA submissions and other R&D submission documentation
  • Lead delegated GLP/GTP/GCLP Inspection Readiness efforts
  • Provide procedural development and other process improvements. Where there is cross-reference and/or cross functionality with other functional controlled procedures, ensure harmonization for alignment and compliance
  • Perform GLP/GTP/GCLP metrics tracking and reporting
  • Own, facilitate and oversee audits, deviations and CAPAs
  • Serve as the primary point of contact for R&D QA controlled documents (i.e. SOPs, WIs, etc.) and R&D QA training and as the subject matter expert for these topics during audits and inspections
  • Monitor GLP/GTP/GCLP non-conformance trends and communicate this information to management with proposed remediation actions
  • Lead R&D QA activities during preparation, conduct, and follow-up for Regulatory Agency inspections and internal audits
  • Track GLP/GTP/GCLP commitments from internal audits, regulatory inspection findings, CAPAs and other regulatory commitments
  • Provide project management and compliance management tracking and reporting to ensure timely and successful milestone completion and limit compliance risks
  • Support GLP/GTP/GCLP compliance and alliance activities with vendors and business partners and lead Quality Agreement creation and revision
  • Collect, track and present all required global R&D QA compliance metrics including vendor and business partner oversight metrics
  • Monitor global GLP/GTP/GCLP regulatory intelligence to determine impact on R&D quality system and develop strategies to implement changes

 

Requirements:

 

  • Bachelor’s Degree or equivalent work experience in a scientific or technical discipline
  • Must have a minimum of 10 years of experience in the areas of GXP regulations with a minimum of 7 years of experience in a GLP/GTP/GCLP quality and compliance role
  • Quality and compliance background, preferably related to GLP/GTP/GCLP
  • Must be familiar with and have experience with QAU responsibilities as described in 21 CFR Part 58
  • Have experience working with exploratory, Phase 0, pre-clinical testing groups
  • Effective communication, consulting, customer service and problem-solving skills
  • Must be detail oriented, capability to meet deadlines
  • PC skills to include solid working knowledge of Microsoft Office software (Excel, Word & PowerPoint required)
  • Excellent time and project management skills
  • Strong interpersonal skills and ability to interact with all levels of the organization and cross-culturally
  • Strategic planning exposure
  • Build positive relationships with regulators, inter and intradepartmental customers, internal and external stakeholders
  • Analyze and interpret regulations and laws and apply to current and future policies and procedures (may include collaboration with other cross functional areas)