QA Specialist Non-Conformance/CAPA

About Astellas Gene Therapies

Astellas Gene Therapies is an Astellas Center of Excellence 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.audentestx.com

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. For more information, please visit our website at https://www.astellas.com/en.

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, Quality Assurance 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, 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.

Primary Responsibilities

Establish and maintain expert knowledge on quality system non-conformance (NC) and CAPA (Corrective Action Preventive Action) 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 requirement changes to functional groups ensuring understanding and implementation of required actions, and overall compliance

Maintain Quality metrics and reporting of site non-conformances and CAPA, working to ensure proper actions are taken by different functional areas to address any metrics requiring action.

Assist in implementation of Astellas Quality Management System for non-conformance and CAPA, providing training, coaching and hypercare to site employees authoring, reviewing, and approving NC/CAPA.

Act as Quality Assurance on deviations/CAPAs, change controls, etc.

Provide guidance to other employees in the execution of records within the Quality Management System and run review board meetings when needed.

Facilitate cross functional team discussions in support of major/critical non-conformance investigations and risk impact 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.

Organizational Context:

The Specialist will typically report to the Associate Director Quality Assurance. This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Astellas Gene Therapies and the Astellas organization.

About you

Must Have/Required

BA/BS or equivalent in Biological/Physical/Chemical sciences, engineering, or equivalent focus of study from an accredited university or college with typically 5-8+ years relevant experience or typically 3-5+ 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)

Will support and demonstrate quality standards to ensure data of highest quality

Works closely with team and other functional key stakeholders on the Astellas AGT team to execute work and will be expected to perform other duties and/or special projects as assigned

Models our Core Values: Be Bold, Care Deeply, #GetStuffDone – 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 facility startup and licensure environment

Experience with Quality Management Systems (Veeva, TrackWise, Veeva Quality Docs, etc.)

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

Working Conditions

This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, and lifting up to 20lbs

This is an on-site role working in a cGMP regulated manufacturing facility

On occasion, this role may travel to other Astellas Gene Therapies manufacturing facilities (0-5%)

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

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.

#LI-LK1

Category Development QA

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans