Senior Specialist, Quality Assurance at Astellas in South San Francisco, California

Job Description:

About Astellas Gene Therapies

Astellas Gene Therapies, An Astellas Company, is developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for their newly created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina. For more information, please visit our website: www.astellasgenetherapies.com

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

We are seeking a highly motivated Senior Specialist, Quality Assurance, reporting to the Senior Manager, Quality Assurance, who will provide input and oversight to ensure all manufacturing quality system requirements are effectively established and maintained, reports on the performance of the quality system to senior levels of management with responsibility for review, and identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations. The Specialist/Senior Specialist, Quality Assurance will be tasked to perform a wide variety of activities to ensure that Astellas Gene Therapies Quality requirements are being fulfilled through effective performance monitoring, ensuring that performance and quality of products conform to established standards and agency guidelines and to identify and implement solutions for issues / gaps discovered to prepare for commercialization.

The position is located in the gene therapy manufacturing facility in South San Francisco, CA.

Responsibilities

* 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
* Develop, manage, and maintain the Quality metrics, working to ensure proper actions are taken by different functional areas to address any metrics requiring action.
* Act as owner for various Quality Systems, i.e., deviations, Change Control, etc.
* Provide guidance to other employees in the execution of records within the Quality Management System and run Review Board meetings when needed.
* Facilitate risk assessment cross functional team discussions in support of major/critical deviation investigations and change controls and draft risk assessment report documents as per defined timelines
* 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 drives for results and effectively network and communicate cross-functionally, cross-site
* Perform other support responsibilities as requested to support Quality and Compliance activities

Must Have/Required

* Senior Specialist: BA/BS or equivalent in Biological/Physical/Chemical sciences, engineering, or equivalent focus of study from an accredited university or college with typically 10+ years relevant experience or typically 8+ years with Master's degree
* 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
* Experience managing and improving Quality Management Systems and metrics
* Proven ability to manage multiple projects while maintaining quality
* Successful history of working independently with minimal supervision
* 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 30%, as required
* Models our Core 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

* Experience with rare/orphan diseases and/or gene therapy products
* Experience in startup environment
* Knowledge of existing and emerging regulations, standards, or guidance documents related to AAV gene therapy production

Benefits:

* Medical, Dental and Vision Insurance
* Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
* 401(k) match and annual company contribution
* Company paid life insurance
* Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
* Long Term Incentive Plan for eligible positions
* Referral bonus program

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled