Director/Senior Director, Clinical/Nonclinical Compliance
Director/Senior Director, Clinical/Nonclinical Compliance
About Audentes Therapeutics
Audentes Therapeutics is a leading AAV-based genetic medicines company focused on developing and commercializing innovative products for serious rare neuromuscular diseases. We are leveraging our AAV gene therapy technology platform and proprietary manufacturing expertise to develop programs across three modalities: gene replacement, vectorized exon skipping, and vectorized RNA knockdown. Our product candidates are showing promising therapeutic profiles in clinical and preclinical studies across a range of neuromuscular diseases. Audentes is a focused, experienced and passionate team driven by the goal of improving the lives of patients.
Audentes takes pride in strong, global relationships with the patient, research, and medical communities, and we take equal pride in carefully selecting our colleagues. If you believe you match what we're looking for, we'd love to hear from you. Our compensation philosophy embodies what you'd expect from an innovative life sciences employer competing for the best talent available.
Listed below is a current opening for which we are seeking smart, driven, experienced, and just plain nice people to join us in realizing Audentes' mission.
Reporting to the to the Senior Vice President, Regulatory Affairs, the Director/Senior Director, Clinical/Nonclinical Compliance will lead and direct this key function for the Company as it commercializes its first products. Working in collaboration with Clinical Development, Nonclinical Development and Regulatory, the Director/Senior Director, Clinical/Nonclinical Compliance will develop, implement and maintain Audentes' global quality strategy for both clinical (GCP) and nonclinical (GLP) activities, and ensure compliance to the strategy, Audentes' policies, and all applicable regulations and guidance, both within Audentes and with its partners and suppliers, to ensure the Company meets its goals.
The specific responsibilities of this position, but not limited to:
- Drive the development and continuous improvement of the Clinical/Nonclinical Quality Management System
- Provide managerial support to one or more employees and contractors with overall responsibility of leading, training, and mentoring for effective performance
- Develop and implement a Clinical / Nonclinical vendor qualification/audit program
- Perform or coordinate domestic and international compliance audits of critical Clinical and Nonclinical vendors/sites, including contract bioanalytical and reference laboratories, data management vendors, and clinical investigator sites
- Ensure audit findings are communicated to audit stakeholders (formal written audit reports) and collaborate with auditees and vendors to track, review, approve, and assess the adequacy of CAPAs
- Perform internal systems audits of Clinical and Nonclinical Development to ensure compliance with CFRs, local regulations, ICH and Audentes policies and procedures
- Develop and maintain a mechanism for tracking audit reports, audit observations, and associated CAPAs. Monitor, track, and facilitate the completion of CAPAs to address significant incidents of GCP / GLP non-compliance.
- Identify, communicate, and escalate significant incidents of GCP / GLP non-compliance and follow to resolution, acting at all times with an appropriate sense of urgency
- Develop and execute Clinical Study Compliance plans. Provide guidance and support to clinical study teams with the investigation of significant incidents of GCP non-compliance
- Partner with the GMP Quality team to develop corporate Quality policies and initiatives
- Conduct, or oversee the conduct of Clinical, Nonclinical and regulatory document audits, ensuring the quality, accuracy and completeness of various documents, including as applicable Trial Master Files, Clinical and Nonclinical Study Reports, Investigator Brochures, and Module 2.6 Tabulated and Written Summaries, and Integrated Summaries
- Develop GCP/GLP inspectional readiness plans and lead inspectional readiness activities
- Host and/or assist with management of GCP/GLP regulatory agency inspections
- Partner with Clinical and Nonclinical Development to review, update and maintain related SOPs, identify the need for new SOPs, and support the review of new SOPs as needed
- With Clinical/Nonclinical stakeholders, develop compliance training materials and conduct training
- Partner with GMP Quality team and Clinical Operations staff to facilitate the investigation of clinical supply quality issues such as temperature excursions, product complaints and deviations reported from clinical sites.
- Support a Quality-focused work environment in Clinical/Nonclinical development that fosters learning, respect, open communication, collaboration, integration, and teamwork
- Initiate and participate in Quality improvement program working groups and project teams
Required Education, Skills and Experience
- BS degree in a scientific area, with 12+ years of biotechnology/pharmaceutical industry experience including 7+ years managing GCP/GLP auditing/compliance in either Quality Assurance or Compliance for both clinical and nonclinical and 3+ years of management experience
- Proven experience developing/implementing vendor qualification and audit programs
- Demonstrated experience managing/supporting regulatory authority inspections
- Thorough understanding of applicable US and international regulations/guidelines to facilitate the interpretation and impact of findings of internal and external audits, current knowledge of ICH Guidelines governing clinical trials, nonclinical studies and recent global regulatory initiatives,
- including 21 CFR Part 50, 56, 58 and 312 along with ICH E6
- Proven experience in a global environment from a regulatory/GCP compliance/inspectional readiness perspective
- Strong knowledge of regulatory compliance and QA issues within a pharmaceutical, biotech or medical device organization
- Proven experience auditing/working with external vendors
- Outstanding collaboration, problem solving team player with excellent written and oral communication and organizational skills
- Excellent organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
- Successful record of working effectively and cooperatively in a team environment under significant time pressure and effectively manage consulting auditors
- Must be capable and willing to travel (up to 30%), including international travel
- Strong computer skills including MS Office (Word, Excel, Outlook, PowerPoint, Project)
- Commitment to Audentes values: Be BOLD, Care deeply, #GSD
Preferred Education, Skills and Experience
- Advanced degree
- Experience in a startup environment
- Rare/orphan disease experience
|Posted on||21 Mar 2019|
|More details (document)|