Specialist, Quality Systems & Compliance

Purpose & Scope

Senior Specialist, Quality Systems & Compliance, reporting to the Senior Manager, Quality Systems and Compliance, will support Supplier Quality Management Program activities including managing vendor changes, supplier complaints, quality agreements and ensuring resolution of issues related to external vendors. Collaborates with key internal stakeholders to ensure quality related aspects are incorporated into the supplier management program. Additionally, this position will support audits and inspections and ensure inspection readiness of the site through consistent adherence to cGMPs confirmed during execution of the self-inspection (internal audit) program.

Role and 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 internal and external deviations and change controls.
• Demonstrate high level of involvement in continuous improvement of quality assurance philosophy and practices to ensure the highest standards are maintained.
• Effectively drives for results and effectively network and communicate cross-functionally, cross-site.
• Supports continuous improvement and drives compliance through gap assessments and compliance changes to stay aligned with regulatory guidelines.
• Support 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 as GMP/Compliance Walkthroughs.
• Supports internal audits in support of improving site compliance and inspection readiness.
• Prepares and completes audit reports and communicates 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 Pre-Approval and regulatory inspections including compiling / reviewing documents, policies and procedures to ensure audit readiness, inspection readiness training, management of mock inspections, and management of inspections.
• Prepares metrics and provide updates related to supplier quality and general site compliance.
• Performs other responsibilities as requested to support Quality Compliance.
• Performs other duties as assigned or special projects as needed.

Qualifications

• BA/BS or equivalent in related scientific or technical discipline or equivalent focus of study from an accredited university or college with 10+ years relevant experience
• 8+ years with MS degree; 4+ years of experience in a related quality function in a regulated industry.
• 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.
• Well-organized and detailed oriented professional, with strong verbal and written communication skills
• Advanced computer skills with working knowledge of MS office such as Word, Excel, Access, Adobe Acrobat, and SharePoint
• Must be self-motivated with ability to handle, organize and prioritize multiple tasks and be able to perform under pressure to meet production deadlines.

Preferred Qualifications

• Experience with internal and/or external auditing; certifications preferred (e.g. CQA, ASQ or other as applicable)
• Knowledge of existing and emerging regulations, standards, or guidance documents related to AAV gene therapy production
• Experience in a GMP facility startup, high growth, and fast-paced environment
• Experience working with Quality systems in support of early, late-stage development, and commercial programs.
• Experience with quality management systems (e.g. Veeva, TrackWise)

Location and Working Environment

This position is an on-site role working in a cGMP regulated manufacturing facility based in Sanford, NC and will require on-site work. On occasion, this role may travel to other Astellas Gene Therapies manufacturing facilities and/or domestically up to 15% for audit support, as required.