Manager Quality Assurance

Profile

Are you ready to use your experience and expertise to make an impact on patients' lives? Astellas Gene Therapies is a biotechnology company developing new genetic medicines for rare, life-threatening diseases. We are working urgently to progress our medicines and need additional team members to help us do so. Because our mission is so important, our values are to: Be BOLD:

Find a Way, Care Deeply, and Get Stuff Done.

If you'd like to be a part of this important mission, please apply to join our team.

About Astellas Gene Therapies

Astellas Gene Therapies (AGT) 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 Associate Director of Quality Assurance Operations (QA Ops), the primary focus of the Manager, QA Ops will be to establish and perform the quality assurance review and oversight functions in support of the AGT quality management system and gene therapy manufacturing facility. Initially, this role will primarily focus on the qualification and cGMP readiness of our new gene therapy manufacturing facility located in Sanford, NC. This role manages activities required to implement and monitor routine systems, procedures, and records to support cGxP-compliant manufacturing, batch review and release of AGT biological products. Responsibilities include ensuring adherence to agency regulations (GxP) and guidance, industry best practices, local regulations, and internal policies and procedures. This role will be located at our North Carolina, Sanford location.

Primary Responsibilities

The Manager for QA Operations is responsible for providing leadership and daily support and oversight to GMP operations

Recruit, manage, develop, and retain

Quality Assurance Operations staff

who embrace AGT Sanford's culture and core values

Manages daily work of personnel and tracking department metrics to ensure productivity and alignment with departmental/site goals

Establish and foster a cGMP quality culture that prepares the site for regulatory pre-approval inspections and eventual licensure for commercial manufacturing

Provide QA Oversight of Manufacturing, Facilities, Supply Chain, and other supporting functions to ensure compliant operations

Manages the following activities: release of incoming materials, QA MFG operations, material qualification, facilities including asset review and approvals, QA area walkthroughs, Batch Record Review and product disposition

Build relationships with key counterparts and stakeholders in South San Francisco to establish aligned QA Operations and related processes that meet both regulatory guidance and company policies

Participate in and approve quality investigations, assessments, and reviews or evaluations of quality events such as deviations, CAPA, and change records

Author, review, and approve SOPs and other quality documents

Manage and facilitate the drug substance lot disposition status meetings

Actively participate and represent the company in regulatory (e.g., FDA, EMA, DHHS, etc.) inspections and audit activities conducted by third-party and corporate partners as quality process owner for documentation and records management programs

Propose and implement KPIs that are meaningful measures and indications of the system and internal process performance. Analyze data and provide site leadership with periodic updates on performance against quality plans and overall quality system health and GMP compliance

Track and resolve emerging inspection readiness gaps; develop remediation plans to mitigate compliance risks to assure that regulatory and quality requirements have been met

Some travel (

Requirements

About you

Must Have/Required

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

Bachelor's degree in a related scientific or technical discipline with 8 years of experience in biotechnology or pharmaceutical industry; with 4 years of experience in QA operations and/or related quality function in a regulated industry, and experience with managing personnel.

Working knowledge of US and International GMPs, FDA/ICH Guidance, and best practices in a biotech manufacturing and testing environment

Strong people management skills with proven ability and enthusiasm to lead, motivate, inspire, develop, and encourage staff

Well-organized and detailed oriented professional, with strong verbal and written communication skills

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

Demonstrated experience representing as the process owner on internal, external and third-party audits

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 able to perform under pressure to meet production deadlines

Proven experience with electronic quality management system and electronic signatures

May Have/Preferred

Master's degree in a scientific discipline

Experience in a GMP facility startup, high growth, and fast-paced environment

Experience working with Quality systems in a commercial-ready gene therapy facility.

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

NC, Sanford

Category

Quality Assurance/Quality Control

Company info

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