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Astellas Pharma Manager, Quality Training in South San Francisco, California

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

We are seeking a highly motivated Manager, Quality Training who will be oversee the day-to-day operation of the Quality Training department and foster a culture of learning and engagement at the Astellas Gene Therapies (AGT) manufacturing facility in South San Francisco, CA. Reporting to the Associate Director, GMP Training, this role will manage a team of quality professionals to ensure site learning needs are identified and met, identify appropriate training/learning solutions, administer the learning management system (LMS) and support execution of a strategy focused on increasing training effectiveness, efficiency, and continuous improvement while strengthening AGT employee engagement, knowledge, abilities, and performance.

Primary Responsibilities

  • Establish and foster a quality culture where learning and improvement are foundational elements of operating to prepare the site for regulatory pre-approval inspections and licensure for commercial manufacturing

  • Oversee daily operation of the site Quality Training team; coach and develop team members to ensure continuity of operations and improve engagement and individual employee development

  • Provide strategic direction to ensure continuous improvement of the GxP training program and related business processes

  • Develop standard work plans, schedules, and coordinate activities to ensure completion of assigned objectives; contribute to development and execution of short- and long-term training improvement initiatives

  • Support or manage deployment of site or corporate training initiatives, annual GxP training, and other fundamental knowledge enhancement training programs

  • Ensure proper methods of instructional design are employed to maximize knowledge transfer and retention during training

  • Monitor training curricula and learning plans to ensure they are accurately developed, managed, and maintained

  • Support Astellas QMS integration activities to meet project timelines associated with the migration to the Astellas enterprise systems and transition of the current electronic LMS, MasterControl, to the SAP SuccessFactors platform

  • Track, trend, and interpret training data to measure system and internal process performance to ensure strategic goals are met; analyze KPIs and provide periodic updates on performance against quality plans and overall system health and compliance

  • 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 a subject matter expert

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

  • This is an onsite role based at the South San Francisco location.

  • Some travel (< 5%) may be required

About you

Must Have/Required

  • Bachelor's degree with 8+ years of experience in Training and/or a related Quality function in biopharmaceutical manufacturing or a regulated manufacturing facility or Master's degree with 5+ years of experience in a Quality function with experience managing, mentoring and training personnel

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

  • Basic understanding of adult learning techniques and instructional design

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

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

  • Computer literacy and working knowledge of Microsoft Word, Excel, Access, SharePoint, and Adobe Acrobat

  • Must be self-motivated with ability to handle, organize and prioritize multiple tasks and able to perform under pressure to meet production deadlines

  • 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 small company and high growth, fast-paced environment

  • Bachelor's degree

  • Experience in a startup, high growth, and fast paced environment

  • Experience working with Quality systems in support of early and late-stage development programs

  • Experience with administration of electronic learning or document management systems, preferably SAP SuccessFactors and Veeva Vault

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

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Category Quality Assurance

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans

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