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Associate, Quality Training (GMP)

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 .

**Astellas Institute for Regenerative Medicine (AIRM)** is a wholly-owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's health around the world through the provision of innovative and reliable pharmaceutical products.

AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts.

Astellas is announcing a **Associate, Quality Training (GMP)** opportunity at their **Astellas Institute for Regenerative Medicine (AIRM)** site in **Westborough, MA.**

Purpose:

The Associate, Quality Training (GMP) will assist in maintaining and facilitating all aspects of cGMP training, along with ensuring compliance with applicable regulations through appropriate documentation and approved training content. This position will help provide programs, services and systems designed to assist people with managing their learning at work.

Essential Job Responsibilities:

Essential Duties and Responsibilities include, but are not limited to, the following:

+ Collaborate closely with all department management at AIRM to determine training needs, assist with establishing training curriculums and assignments based upon work functions, and schedule training sessions.

+ Partner with functional areas to conduct monitoring of training compliance status, efficiency checks, and trend results.

+ Provide support in development of training materials and knowledge assessments for area processes.

+ Support the QA Training team in completion of site training objectives and goals.

+ Track and monitor metrics related to individual and departmental trainings and reacting to those metrics to ensure compliance with the training program.

+ Coordinate training through the validated Learning Management System (LMS) in use at AIRM.

+ Identify training needs and opportunities for all employees across all levels.

+ Assist with internal and external audits, as required.

+ Ensure effective and timely investigations are performed as well as appropriate CAPA’s implemented to prevent reoccurrence.

+ Support the on-boarding process (e.g. work with management to identify the proper assignment of Job Code(s) for the New Hire in the LMS, obtain the New Hire’s Resume/CV, etc.

+ Coaches Trainees on the successful use of the LMS, ensuring accurate training practices are followed, and assists Trainees in the completion of training in the LMS.

+ Represent the Training function in reviewing GMP procedural documents, training materials, and executed training records to ensure required standards are met.

+ File physical training records in the records storage room.

Qualifications

Required:

+ BS degree with 2+ or MS with 0+ years of experience working in a CGMP environment BA/BS or equivalent.

+ Experience with developing or delivering training to colleagues and/or managing a training program and LMS.

+ Familiarity with electronic systems, including PowerPoint, Excel and Learning Management Systems.

+ Basic familiarity with FDA regulations including Good Laboratory Practice (GLP) and current Good Manufacturing Practice (cGMP) regulations, FDA Guidance, and ICH Guidance.

+ Ability to work independently without significant oversight or instruction to achieve results with a high degree of accuracy and attention to detail.

Preferred:

+ Bachelor’s level degree in life science, instructional design, or related field preferred.

+ Strong content knowledge of CGMP/regulatory compliance.

+ Manufacturing and/or Quality experience.

+ Experience with Plateau Learning Management System.

Working Conditions

+ This position is based in Westborough, MA and will require on-site work.

Benefits:

+ Medical, Dental and Vision Insurance

+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks

+ 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

\#LI-TD

Category BioPharma QA

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

EOE including Disability/Protected Veterans