• Ultragenyx Pharmaceutical
  • Cambridge , MA
  • Scientific Research
  • Full-Time
  • 101 Auburn St

Position Summary Develop, implement, and execute the audit strategy and plan for clinical programs at Ultragenyx Gene Therapy (UGT) located in Cambridge, MA and Ultragenyx Pharmaceutical (UGX) located in Novato & Brisbane, CA Partner with Clinical Study teams to ensure studies are compliant with applicable regulatory requirements through operational activities and training Implement, communicate, and monitor UGX & UGTs Quality, GxP compliance audit and inspection readiness approach to clinical study teams and key stakeholders Contribute in developing and creating the Clinical QA infrastructure and strategic direction Train/coach Clinical QA and/or other QA personnel in preparing, conducting, and reporting GxP audits of investigational sites, Service Providers, CROs, and other types of audit as assigned Execute the Clinical QA, GxP Compliance Audit and Inspection Readiness strategic goals and objectives

Responsibilities

  • Deploy and manage UGTs GCP oversight, compliance audit and inspection readiness system to the Clinical Study Team to ensure quality product during clinical trials and compliance with ICH guidelines, FDA/EMA/applicable global health authority regulations related to GxPs
  • Oversee overall GxP Compliance objectives and long-range goals for Clinical audit program at UGT and UGX
  • Develop, maintain and implement internal and external audit programs to satisfy contractual and regulatory requirements for GCP
  • Develop, maintain and implement audit programs to support the clinical study programs
  • Optimize resources for Clinical audit program
  • Conduct GxP audits which includes but is not limited to investigational site, Service Providers, CROs
  • Represent QA on clinical study team s operational activities
  • Provide guidance on GCP compliance matters with clinical study teams
  • Promote performance improvement with the Clinical Study Team and key stakeholders through a proactive and engaging compliance audit and inspection readiness system
  • Review GCP-associated controlled documents which may include standard operation procedures (SOPs), protocols/amendments, study plans, etc. in accordance with applicable regulatory requirements (e.g., ICH E6, FDA, EMA, MHRA, local regulations)
  • Train/coach QA personnel in GxP audits (as assigned) and provide timely feedback
  • Develop department specific standards and SOPS in support of the Quality System and proactive quality program
  • Proactively engage in collaboration with internal and external stakeholders to include health authorities and industry trade organizations to identify compliance trends and incorporate them into ongoing quality audit plans
  • Utilize the Quality Management System and Health Authority requirements and expectations as the basis for development and management of processes
  • Work with management of GxP-regulated internal groups to identify process improvements for building compliance into the design and conduct of clinical activities
  • Actively support inspection readiness activities and associated Health Authority Inspections
  • Collaborate with internal and/or external stakeholders to ensure management of GxP compliance issues and risks
  • Evaluate GxP compliance status in relationship to industry and Regulatory Agency expectations and assesses the effectiveness of corrective and preventative actions in response to internal and third-party audits. Publish results to ensure global wide company awareness
  • Write and/or participate in corporate document development, as required
  • Ensure active senior management engagement and visibility to Ultragenyx s compliance status and risks through the Quality Management Review process
  • Participate in GxP related meetings to ensure abreast with new emerging and updates to GxP regulations. Acts as a SME for GxP Compliance
  • Attend meetings, conferences and workshops benchmarking industry activities and provides updates to Senior Management
  • Perform any other tasks as requested by the Executive Director of Clinical QA and/or Executive Management to support Quality oversight activities
  • Requirements

  • Bachelor's Degree is required in Biological Science, Chemistry or related technical discipline.
  • 7+ years experience in Biotech/Pharmaceutical industry
  • Strong working knowledge and interpretation of FDA/EU and ICH GxP regulations and guidelines
  • Broad and direct experience with regulatory authority inspections, including both FDA and EMA inspections
  • Hands on understanding detailed QMS procedures and GxP regulated requirements and expectations
  • Experience working with Contract clinical, Service Providers, and other entities which provides GxP contracted services
  • Capable of collaboratively engaging with external 3rd parties to effectively execute the audit and inspection readiness strategy and approach.
  • Experienced in all phases of biologic and small molecule drug development.
  • Flexible in the face of shifting needs and/or priorities.
  • Able to interface well with all levels of personnel, including peers and other department heads such as: Clinical, Safety, Clinical Affairs, Data Management, Biostatistics, Regulatory, Technical Operations, Quality Operations, Supply Chain and Project / Program Management.
  • Experience with computerized systems and compliance requirements, involving both on-premises and hosted environments.
  • Capacity to produce high quality results across multiple projects and prioritize demands while working under short deadlines associated with a fast-paced dynamic scientific environment.
  • Excellent communications skills, both written and verbal.
  • Excellent teamwork, interpersonal skills and negotiation skills, both internally and externally.
  • Strategic thinker, open-minded and flexible to adopting new ideas.
  • Motivated, committed and self-managed.
  • Focuses on practical, commonsense and sensible approaches to finding effective solutions with a focus on embedding strong quality and compliance behaviors as well as deploying the QMS.
  • Willingness to work in a dynamic and changing corporate environment.
  • Requires a flexible work schedule to accommodate program priorities and international activities as needed.
  • Must be willing to travel 30% of time
  • This position is based in Cambridge, MA and will report through an Executive Director located in Brisbane, CA
  • Ultragenyx Pharmaceutical Inc. is an equal opportunity employer. We understand that diversity of thought, culture and background will help us do the best for our patients. We prohibit unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.
    Associated topics: process, prevent, prevention, quality assurance analyst, quality assurance engineer, quality assurance lead, software quality assurance, software quality assurance engineer, test, test engineer

    * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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