Senior Specialist, Quality Assurance, Quality Systems & Compliance at Astellas in Sanford, North Carolina

Job Description:

Senior Specialist, Quality Systems & Compliance

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.

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.astellasgenetherapies.com.

The Role:

The Specialist, Quality Systems & Compliance, reporting to the Manager, Quality Systems and Compliance, will support the Supplier Quality Management Program activities. This includes GMP audits of Suppliers and Contract Manufacturing Organizations (CMO), managing vendor changes, supplier complaints (SCARs), and quality agreements, ensuring resolution of critical issues related to external vendors and management of other aspects of supplier qualification. Collaborates with key internal stakeholders to ensure quality related aspects are incorporated into the supplier management program. Additional this position will ensure inspection readiness of the site through consistent adherence to cGMPs confirmed during execution of the self-inspection/internal audit program.

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.


• 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.


• 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.


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


• Supports 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 inspections.


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


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