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Associate Director, Functional Quality Business Partner, R&D Quality
3 months ago
Associate Director, Functional Quality Business Partner, R&D Quality
Contact Details: Full time; 12 months; Hybrid with core on-site days Tuesday-Thursday
Location: Foster City, CA
POSITION OVERVIEW:
You will act as the R&D Quality Business Partner to assigned groups, such as R&D functions or vendors supporting R&D. You will provide strategic, expert advice and consultation on R&D quality, risk and continuous improvement with impact across cross-functional Good Clinical Practices (GCP). You will educate assigned groups on quality policy and procedural standards, GCP regulations and other requirements. You will provide expert advice on GCP risk minimization and mitigation. You will help the business understand the potential impacts of risk and alternatives to best address risk. You will also provide leadership support in escalating quality risks or issues. You will participate in Quality forums, cross-functional teams and/or projects. You will act as the central point of contact for QMS-related communications to assigned groups; consolidating and channelling just-in-time information and resources to assist assigned groups. You will 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 during regulatory inspections.
EXAMPLE RESPONSIBILITIES:
• Serves as Quality Business Partner lead for assigned R&D functions, programs and/or vendors. Handles multiple projects simultaneously and ensures overall and timely completion of tasks.
• Works closely with businesses 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 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.
REQUIREMENTS:
Education & Experience
• PharmD/PhD with 2+ years’ experience.
• MA/MS/MBA with 8+ years’ relevant experience.
• BA/BS with 10+ years’ relevant experience.
• Significant experience advising business functions in the biopharma 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.
Knowledge & Other Requirements
• Thorough knowledge of standards, systems, policies and procedures that enable Good Clinical Practices (GCP), QMS operations and compliance within the biopharma 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.
