Quality Senior Specialist Quality Systems & Compliance

About Astellas Gene Therapies

Astellas Gene Therapies 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. Astellas Gene Therapies is a focused, experienced and passionate team driven to improve the lives of patients.

Astellas Gene Therapies leverages strong, global relationships with the patient, research, and medical communities, and we take pride in carefully selecting our colleagues. Listed below is a current opening for a smart, driven, experienced, and just plain nice individual who wants to join us on our journey.

The Role

The Senior Specialist, Quality Systems & Compliance, reporting to the Sr. Manager, Quality Systems and Compliance, 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 Sanford, North Carolina.

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

Required Qualifications

  • 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: 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

Preferred Qualifications

  • 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

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 (up to 15%)

Benefits:

  • Medical, Dental and Vision Insurance

  • Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including 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

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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.

Category Development QA

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

EOE including Disability/Protected Veterans

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