Senior Manager, QA Compliance at Astellas in Sanford, North Carolina

Job Description:

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.

This position is located onsite at the Sanford, NC location.

The Role

The primary purpose of the Senior Manager, Quality Assurance, Compliance is to provide Quality and Compliance oversight to Astellas Gene Therapies (AGT). The role is responsible for implementation and oversight of the AGT Supplier Management program, internal audit program, inspection management and compliance oversight required to support GMP manufacturing operations at AGT GMP operations as well as GMP suppliers. This role will be responsible for maintenance of supplier qualification program, negotiation of quality agreements and ensuring compliance with internal and external audit schedules.

Responsibilities

• Implements and improves programs in alignment with corporate directives and best practices.


• Ensures that quality agreements are negotiated, approved, and assessed periodically.


• Manages Astellas Gene Therapies' supplier qualification program: Maintains approved supplier list (ASL), ensure that supplier qualification is maintained, ensure compliance to supplier audit schedule, establish and manage supplier quality metrics and report outs to stakeholders.


• Manages supplier qualification and lifecycle management activities, including initial qualification, requalification and disqualification.


• Ensures supplier management activities including audits, quality agreements and SCAR programs are operated within compliance and within performance metrics.


• Ensures metrics are routinely tracked and reports in departmental and site management review.


• Conducts quality audits at suppliers and contract manufacturers, report results to project team personnel and management, and interact with teams to ensure corrective actions are implemented.


• Designs and actively participates in special assignments on various project teams and work streams as determined by QA management.


• Directs internal audit program, including ensuring annual schedule is approved, audits are executed, and corrective actions are implemented to improve compliance.


• Establishes and leads inspection readiness program to ensure successful licensure of new gene therapy products and act as host for corporate, QP and health authority inspections.


• Maintain compliance related documents including Site Master File (SMF) and Annual Product Quality Review (APQR) for commercial products.


• Lead regulatory inspections and corporate auditing related projects.


• Performs other duties as assigned or special projects as needed.