Specialist, Quality Compliance

Specialist, Quality 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.

The Role

The Specialist, Quality Compliance performs a wide variety of activities to ensure compliance with applicable GXP requirements and drives the development, coordination, and preparation for Audentes' upcoming inspections and inspection readiness. The Specialist, Quality Compliance is responsible for supporting all the documentation and compliance needs for a fast paced and dynamic team. This position will be located in South San Francisco.

The specific responsibilities of this position include:

  • Monitors policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency guidelines and to identify and implement solutions for issues / gaps discovered.
  • Establish and maintain expert knowledge on quality systems/regulatory requirements in accordance with applicable FDA Regulations (21 CFR: Parts 600, 211), EudraLex and ICH Guidance, as well as other applicable regulatory requirements applicable to the organization, continuously review guidance publications for industry and upcoming changes to regulations.
  • Effectively communicate regulatory / compliance requirements changes to functional groups ensuring understanding and implementation of required actions, and overall compliance
  • Provide guidance to other employees in the interpretation of technical/scientific issues across a majority of the job functions and manage development of technical or scientific initiatives and activities by interdisciplinary teams 
  • Work with Associate Director, Quality Compliance on QA project initiatives, to provide leadership and direction to drive timely results / quality output on projects including but not limited to site inspection readiness, training development and Quality System continuous improvement projects
  • Assume a leadership role for the preparation, execution and follow up activities related to regulatory inspections and Pre-Approval inspections including compiling  / reviewing documents, policies and procedures to ensure audit readiness, including participating in internal audits, inspection readiness training, management of mock inspections, and management of inspection logistics
  • Demonstrate high level of involvement in continuous improvement of quality assurance philosophy and practices to ensure the highest standards are maintained. Examines programs to create efficiencies in practices and optimal utilization of staff.
  • Effectively communicate with all levels of management and direct reports the importance of compliance to applicable regulatory requirements to all levels of the organizations through development and delivery of live training and online training materials, and creation/update of policies and procedures.
  • Establish and maintain site metrics and facilitate Quality Management Review program as needed
  • Perform other support responsibilities as requested to support Quality and Regulatory oversight activities

Required Education, Skills and Experience

  • Bachelor's degree in Chemistry, Pharmacy or scientific field with 7+ years' or Master's degree with 4+ years' progressive global quality assurance background in pharma/biotech and 3+ years' of hands on cGMP/GLP Compliance experience
  • Current and working knowledge interpretation/implementation of United States Code of Federal Regulations, ICH Guidelines and other local government regulatory requirements governing training and document management requirements
  • Excellent verbal and written communication skills, ability to lead cross-functional teams and independently prioritize work
  • Proven ability to manage multiple projects while maintaining quality
  • Successful history of working independently with minimal supervision
  • Excellent organizational, interpersonal and communication skills (oral and written)
  • Strong interpersonal skills with reputation for collaboration with colleagues
  • Strong computer skills including MS Office (Word, Excel, PowerPoint, MS  Project)
  • Travel internationally and domestically up to 15%, as required
  • Commitment to Audentes values: Be BOLD, Care deeply, #GSD 

Preferred Education, Skills and Experience

  • Experience with rare/orphan diseases and/or gene therapy products
  • Experience in startup environment

Job Details

Reference # 2019B-152
Posted on 22 Mar 2019
Closes on
Location(s) South San Francisco
Department Quality
Career level Experienced (non-management)
Hours/Status Full-time
More details (document)
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