We are seeking a highly motivated Senior Specialist, Quality Systems & Compliance, reporting to the Associate Director, Quality Systems & Compliance, who will provide input and oversight to ensure all manufacturing quality system requirements are effectively established and maintained; report 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 requirements, as well as domestic and international quality regulations. The Specialist/Senior Specialist, Quality Systems & Compliance, 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; to ensure 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.

This position will be located in South San Francisco.

Primary 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 changes in regulatory / compliance requirements to functional groups ensuring understanding and implementation of required actions, and overall compliance.

• Facilitate 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.

• Effectively drives for results and effectively network and communicate cross-functionally, cross-site.

• Drives continuous improvement of the AGT QMS through new QMR content that includes communication and escalation of Quality System health.

• Supports continuous improvement and drives compliance through gap assessments and compliance changes to stay aligned with regulatory guidelines.

• Will lead the execution, maintenance, and periodic review of Quality Agreements with external suppliers/vendors.

• Provides QA oversight throughout the lifecycle of the Vendor Change Notification (VCN) process and ensures timely completion execution/management of related Change Controls prior to the vendor change being made.

• Supports increased inspection readiness activities such GMP/Compliance Walkthroughs.

• Executes internal audits in support of improving site compliance and inspection readiness.

• Executes supplier audits and implements Astellas requirements where applicable.

• Prepares and completes audit reports and communicate results internally to other groups.

• Conduct reviews of and maintains the Approved Supplier List in support of the external supplier lifecycle.

• Supports the preparation, execution, and follow up activities related to and Pre-Approval and regulatory inspections including compiling / reviewing documents, policies and procedures to ensure audit readiness, including inspection readiness training, management of mock inspections, and management of inspection logistics.

• Prepare metrics and provide updates related to supplier quality, audits, and general site compliance

• Perform other support responsibilities as requested to support Quality and Regulatory oversight activities

Must Have/Required

• Specialist : BA/BS or equivalent in Biological/Physical/Chemical sciences, engineering, or equivalent focus of study from an accredited university or college with typically 7+ years relevant experience or typically 4+ years with Master’s degree

• 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

• 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 15%, as required

• 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 internal or external auditing

• 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

Salary Range

• $94,000 - $126,000 (NOTE: Final salary could be more or less, based on experience)

Benefits:

• Medical, Dental and Vision Insurance

• Generous Paid Time Off options, including Vacation, Sick time, national holidays, two Heritage Days, and Summer and Winter Breaks

• 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

Category Product QA

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

EOE including Disability/Protected Veterans