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Astellas Pharma Senior Specialist, Research Quality Assurance in South San Francisco, California

About Astellas Gene Therapies

Astellas Gene Therapies is an Astellas Center of Excellence developing genetic medicines with the potential to deliver transformative value for patients. Based on an innovative scientific approach and industry leading internal manufacturing capability and expertise, we are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown and will also advance additional Astellas gene therapy programs toward clinical investigation. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina.

About Astellas

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients.

Our Values:

  • Be BOLD (Find a Way)

  • Care Deeply -- for our patients, each other and our work

  • #GSD (Get Stuff Done)

What is the catalyst for you in your professional career? Are you ready to be a part of a bold, innovative company, to make a change and to make a difference? Listed below is a current opening for a smart, driven, experienced, and just plain nice individual who wants to join us and be a part of our journey.

The Role:

The Specialist/ Manager is primarily responsible to implement, maintain and manage the Nonclinical document archives in compliance with applicable regulatory requirements and SOPs in addition to basic auditing needs.

Primary Responsibilities:

  • Revise and develop archive SOPs (and forms) to ensure archival activities comply with regulatory requirements

  • Archive completed Nonclinical study raw data, protocol, reports, electronic data/records, and any other relevant documents following the appropriate cataloging system based on current SOPs

  • Ensure that the archive system allows for orderly storage and expedient retrieval of all raw data, documentation, protocols, samples, and final reports, for example, during regulatory inspection

  • Revise and develop archive SOPs (and forms) to ensure archival activities comply with regulatory requirements

  • Archive completed Nonclinical study raw data, protocol, reports, electronic data/records, and any other relevant documents following the appropriate cataloging system based on current SOPs

  • Ensure that the archive system allows for orderly storage and expedient retrieval of all raw data, documentation, protocols, samples and final reports, for example, during regulatory inspection

  • Support the GLP QAU general auditing needs, including through scheduling of pre-audit and audit-debrief meetings, distribution of audit reports, tracking of audits, Certificate of testing data review

  • Audit support will occupy roughly 20 - 25% of time, archiving 75 -- 80%

Must Have/Required

  • Bachelor's degree or equivalent with 5-7 years in a regulatory industry supporting Nonclinical activities.

  • Experience in Nonclinical archiving activities.

  • Knowledge of GLP regulatory requirements e.g. 21 CFR Part 58, OECD etc.

  • Ability to handle changing priorities if needed in a fast-paced environment

  • Proficient in computer skills; departmental database (Access), MS Word, Excel, Adobe, database applications

  • Excellent and effective written, verbal communication, presentation skills, personal learning, Integrity & Trust

  • Ability to work on a team or independently & detail oriented

  • Ability to travel up to 10% domestic, if required

  • Models our Values: Be Bold: Find a Way, Care Deeply, Get Stuff Done -- is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted

May Have/Preferred

  • Knowledge of existing and emerging regulations, standards, or guidance documents related to AAV gene therapy production

  • Experience with board of health inspections and direct interaction with inspectors

#LI-LK

Category Development

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

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