Manager Quality Assurance

Profile

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

About Astellas

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx ® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at

https://www.astellas.com/en.

Our Values:

Be

BOLD (Find a Way)

Care Deeply

for our patients, each other and our work

#GSD

(Get Stuff Done)

What is the catalyst for you in your professional career? Are you ready to be a part of a bold, innovative company, to make a change and to make a difference? Listed below is a current opening for a smart, driven, experienced, and just plain nice individual who wants to join us and be a part of our journey.

The Role

Reporting to the Senior Manager, Quality Assurance,

the

primary focus of the Manager, Quality Assurance will be to establish and perform the quality assurance review and oversight functions in support of the Astellas Gene Therapies quality management system and gene therapy manufacturing facility. This role will help implement and monitor the routine systems, procedures, and records to support GMP-compliant manufacturing, and batch review and release of Astellas Gene Therapy biological products.

Responsibilities include ensuring adherence to agency regulations (GxP) and guidance, industry best practices, local regulations, and internal policies and procedures.

Demonstrates a high level of involvement in continuous

improvement of quality assurance philosophy and practices to ensure the highest standards are maintained.

This individual is responsible for providing senior level support for issues of moderate complexity.

This role will be located at our South San Francisco location

Primary Responsibilities

Supervise a team of shift Supervisors/QA Associates who work closely with Development, Engineering, Manufacturing, Facilities, Supply Chain, Validation, Document Control, and other supporting functions to ensure compliance

Ensure cGMP compliance of internal GMP gene therapy manufacturing facility and keep

up to date to meet global regulatory requirements.

Provide hands on QA support and oversight to internal staff and suppliers/contractors to ensure compliance to SOPs and relevant Good Regulated Practice (GxP) requirements.

Develop and manage the CMO Quality infrastructure and release process (e.g., SOPs, batch records, specifications approval) necessary for the oversight of Astellas Gene Therapies' external supply chain.

Provide leadership to ensure timely, well-documented, and compliant resolution of quality event investigations and implementation of corrective actions and change controls that maintain a continual state of regulatory compliance.

Partners with peers within Quality, Manufacturing to develop solutions for moderate to complex problems

Work on moderate to complex issues through data analysis and application of Astellas Gene Therapies and regulatory requirements

Work with direct line management to identify areas of process improvements and contribute to the development of new concepts, techniques, and standards

Provides insightful and strategic input into more complex issues

Ensures practices in manufacturing and support areas are consistent with quality and regulatory standards

Manage and facilitate drug substance and drug product lot disposition status meetings

Approve preventive maintenance, calibration, and work orders in the electronic asset management system.

Actively participate in the hosting of regulatory (e.g., FDA, EMA, DHHS, etc.) inspections

Write, review, and approve SOPs and other quality documents

Review and approve CMC documents such as batch records, methods, validation protocols and reports, and testing data

Keep up to date with relevant guidelines and assist with the development and delivery of internal compliance training programs

Responsible for establishing, monitoring, and managing to quality metrics, and reporting metrics to QA Sr. Management.

Effectively interact with the quality team and internal stakeholders to support the development, manufacturing, testing, packaging, and release of gene therapy products as needed.

Manage and implement internal quality improvement initiatives in responsible area: evaluate internal processes; suggest/design/implement improvements; create/revise relevant SOPs.

Champion an environment of teamwork and collaboration while maintaining a positive attitude

Requirements

About you

Must Have/Required

Bachelor's degree in a related scientific or technical discipline with 6 years of hands-on experience or Master's degree with 4 years of hands-on experience in a QA function in a biologics cGMP manufacturing facility

3 years of management experience in a QA function, and experience with mentoring and training QA personnel

Strong knowledge of U.S. and international regulatory standards and guidelines experience, including hosting regulatory level inspections, (FDA, EMA, DHHS, etc.)

Successful experience writing and reviewing SOPs and other quality documents

Direct experience with quality investigations, assessments, reviews and/or evaluations of quality events (CAPAs, deviations, Change Control, Document Control, etc.)

Excels in a fast-paced team environment, meets deadlines, and prioritizes work from multiple projects

Strong communication skills as well as sound judgment, and a history of working effectively with others

Success setting clear expectations with individuals and teams

Excellent problem-solving skills and experience with root cause investigations and CAPA determination

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 in a startup environment

Rare/orphan disease experience

Benefits:

Medical, Dental and Vision Insurance

Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down

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

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

Type

Full-time

Location

CA, South San Francisco

Category

Quality Assurance

Company info

Astellas Us, LLC
Website : https://www.astellas.com/us/