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Associate Director Research Development

3 months ago

Foster City, United States Fladger Associates Full time

Responsibilities:

  • Excellent employment opportunity for an Associate Director, Functional Quality Business Partner, R&D Quality in the Foster City, CA area.
  • Hybrid with core on-site days Tuesday-Thursday
  • Will act as the R&D Quality Business Partner to assigned groups, such as company R&D functions or vendors supporting company R&D.
  • Provide strategic, expert advice and consultation on R&D quality, risk and continuous improvement with impact across cross-functional Good Clinical Practices (GCP).
  • Educate assigned groups on company quality policy and procedural standards, GCP regulations and other requirements.
  • Provide expert advice on GCP risk minimization and mitigation.
  • Help the business understand potential impacts of risk and alternatives to best address risk.
  • Also provide leadership support in escalating quality risks or issues.
  • Participate in Quality forums, cross-functional teams and/or projects.
  • Will act as the central point of contact for QMS-related communications to assigned groups; consolidating and channeling just-in-time information and resources to assist assigned groups.
  • Collaborate with other R&D Quality groups to ensure just-in-time support and resources to assigned groups, including - data, reporting, training, audit, inspection, risk assessment and deviation/ CAPA management support.
  • You may support the company during regulatory inspections.
  • Serves as Quality Business Partner lead for assigned company R&D functions, programs and/or vendors.
  • Handles multiple projects simultaneously and ensures overall and timely completion of tasks.
  • Works closely with business to provide expert quality information, manage identified issues, and support continuous improvement.
  • Acts as Subject Matter Expert supporting GCP cross portfolio risk assessment for all activities performed by assigned functions, vendors or relevant to assigned R&D programs.
  • Collaborates with the Audit, Inspection and CAPA Management Team within R&D Quality as required on internal quality audits, regulatory agency inspections, risk assessment, deviations and CAPA activities.
  • Assists in readiness preparation, and/or directly supports regulatory agency inspection.
  • Supports deviation identification, reporting, and CAPA development.
  • Supports evaluation of new regulations and potential implications for company R&D and/or R&D vendors.
  • Evaluates, writes and/or reviews standard operating procedures, and performs other activities in support of an integrated cross-functional QMS.
  • Collaborates with other R&D Quality teams to ensure assigned functions, programs or vendors have timely and robust support for quality data/ analytics and reporting, quality documentation and training, quality technology and systems validation, and other related activities.
  • May lead or support projects.
  • Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.

Experience:

  • PharmD/PhD with 2+ years of experience.
  • MA/MS/MBA with 8+ years of relevant experience.
  • BA/BS with 10+ years of relevant experience.
  • Significant experience advising business functions in the Biopharmaceutical industry on GCP quality and compliance requirements, evolving regulations, risk minimization and mitigation, and continuous improvement.
  • Previous GCP quality experience at a Sponsor or CRO; Previous experience as an auditor highly desired.
  • Experience working across a broad spectrum of quality and/or compliance activities, including authoring and reviewing SOPs, conducting internal auditing, supporting regulatory inspections, developing and managing CAPAs and deviations, and training others on quality and/or compliance requirements.
  • Significant experience participating in cross-functional projects and teams with responsibilities related to clinical trials, or other drug development activities.
  • Experience working with total quality management methodologies, such as Lean Six Sigma, is a plus.
  • Thorough knowledge of standards, systems, policies and procedures that enable Good Clinical Practices (GCP), QMS operations and compliance within the biopharmaceutical industry.
  • Experience with Good Clinical Laboratory Practices (GCLP), Good Pharmacovigilance (GVP) and Electronic Systems Compliance (ESC) is a plus.
  • Thorough knowledge of the drug development process, including all key functions involved in the various stages of drug development from early research through post-marketing.
  • Demonstrates advanced business knowledge and analytical skills, as evidenced by strengths in assessing complex systems and data and understanding the quality and compliance implications.
  • Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives.
  • Strong interpersonal skills and understanding of team dynamics.
  • Strong communication and organizational skills.
  • Strong negotiation and conflict resolution skills.