Associate Director, Quality Assurance (GXP) - Remote

Regulatory Affairs United States


Description

Position at Regulatory Professionals

Regulatory Professionals, a division of Premier Research, is a consultancy firm specializing in drug, biologics and device regulatory affairs. Our purpose as a company is to support our clients by furthering the development of human therapeutics that will benefit the health and well-being of patients around the world. With a presence in the US, EU, Canada and Japan we are growing and looking for talented people to grow our business, advance the goals of our clients and contribute to our unique culture. Our focus is to provide strategic and tactical support in all aspects of regulatory affairs, including preclinical, CMC and clinical development for drugs, biologics, devices, and combination products.

We are seeking a talented Associate Director of Quality Assurance to join our growing team at RPI! This position is available as a fully remote role.

The Associate Director of Quality Assurance, in conjunction with the Director and the QA team, is responsible for assisting with developing, implementing, and supporting both regional and international quality strategies for assigned projects, while acting as the client representative on various cross-functional teams. This role supports and executes quality strategies that advance client goals for GXP compliance with applicable laws, regulations, SOPs, protocols and guidelines for all stages of product development. This position contributes to successful project delivery, while adhering to timelines and budgets, for clients and within RPI. The Associate Director provides advice and guidance for and actively contributes to the development, implementation and maintenance of quality management systems ensuring compliance with current health authority requirements, GXPs, and industry standards.

This position will require individuals to be fully vaccinated against COVID-19 as part of their job responsibilities. Accommodations for new hires who have qualifying medical conditions or sincerely held religious beliefs that conflict with this requirement will be considered on an individual basis.

ROLE RESPONSIBILITIES:

  • Ensure compliant and profitable project/program delivery that meets or exceeds customer and industry standards
  • Assist in Business Development activities, including proposal development, in partnership with Business Development and Financial Accounting Leadership
  • Ensure the successful cross functional delivery of quality assurance services for projects and program for RPI clients by leading the development and management of key deliverables supporting all stages of product development (pre-IND, Phase 1-4 and marketing products).  Deliverables include but are not limited to quality management systems, policies, procedures, audits, inspection readiness, as well as providing guidance and reviews of protocols, reports, records, deviations, and investigations
  • Ensure necessary dedicated support to clients which may include RPI, Premier Research Group and external consultant staff
  • Work with internal management and clients to monitor RPI projects, operational decisions, scheduling and resourcing requirements, and/or contractual clarifications, in order to ensure successful and timely implementation/execution
  • Mentoring, coaching and delivery of SOP or other quality-specific training of RPI and external consultant staff
  • Ensure client and internal feedback is solicited, researched, prioritized, and actioned with clear and transparent communications
  • Lead and support the development of best practices for the quality assurance team to support achieving business goals, ensure smooth running of projects undertaken by the team and for continuous improvement
  • Ensure RPI’s compliance with established internal controls by examining records, reports, operating practices, and documentation
  • Organize, lead and conduct contracted audits (Investigator sites, CROs, Trial Master Files, Laboratories, Vendors, etc.), including preparation of audit plans and reports
  • Develop and drive processes to monitor, set appropriate milestones and track overall project performance
  • Collaborate with other departments as required to execute on timelines to meet strategic goals, ensuring the smooth adoption and functional integration of quality improvement initiatives throughout the organization
  • Maintain current professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks, keeping up with industry standards and participating in relevant professional societies
  • Provide coaching, mentoring and knowledge sharing within the Regulatory Affairs CMC skill group
  • Review and approve timesheets and expense reports and guide the performance of assigned staff
You'll Need:

  • Bachelor’s degree, or international equivalent from an accredited institution, in a life science or health related field; advanced degree preferred
  • 7+ years of progressive Quality Assurance experience in a pharmaceutical, device/diagnostics, cell and gene therapy, or biotechnology company
  • 5+ years’ experience in conducting GXP audits, ISO systems and process audits
  • Minimum 2 years of people management experience
  • Proficient in the drug development process with experience in multiple phases (early and late stage, post-approval)
  • Advanced knowledge of GCP, GLP, GMP, FDA Code of Federal Regulations and other applicable regulatory authority laws and guidelines; industry certification is a plus

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