Manager Pre-Clinical Quality Audits

Profile

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 of Regenerative Medicine (AIRM), a subsidiary of Astellas, located in Westborough, MA, is focused on the development and commercialization of stem cell and regenerative medicine therapies. The location of this position is based in Astellas Institute of Regenerative Medicine (AIRM) site in Westborough, MA., this can be a 50% hybrid (remote-onsite) position

Purpose and Scope:

Responsible for development and maintenance of operational excellence in Research QA (RQA) activities for Astellas sponsored programs. Reports to Director of RQA, Manager of RQA is a member of the US-RQA Team and contributes to the development, implementation and successful execution of the RQA mission, objectives and 3-5 years strategic plan.

The scope of this position is to manage and provide quality oversight for nonclinical studies (pharmacology/pharmacokinetics/toxicology studies) and clinical bioanalysis for regulatory submission that are executed in compliance with international and local regulatory standards including but not limited to Good Laboratory Practice, (GLP), Good Clinical Practice (GCP), JRS (Japanese Reliability Standard) and other relevant regulations.

Essential Job Responsibilities:

Lead and conduct internal audits including writing audit reports, writing observations, and follow-through of observation resolution. This includes Independently performing in-phase audits of non-clinical studies as well as study-specific data audits and reports

Participate in the evaluation and qualification of Nonclinical service providers (new qualification, re-evaluation,)

Independently plan, perform and/or oversee study-specific external audits according to an audit plan, applicable regulations and procedures

Author or revise SOPs to address gaps or necessary improvements to Quality Systems and Data Integrity

Participate in corrective and preventive action teams, assist with investigation, and root cause analysis and verify that actions are implemented and effective

Work closely with cross functional teams independently for routine compliance and quality guidance

Assist with the organization, preparation, coordination, and documentation of regulatory inspections

Conduct risk assessments for assigned area

Archives relevant departmental documents as per regulatory requirements; assists with archiving of study documentation

Supporting achievements of departmental goals

Quantitative Dimensions:

Managing audit programs which approximately contain between 10-15 audits annually and focus on Nonclinical activities, depending on the complexity

Approximately 50% of time is spent in audit role and an equal amount in the consultancy role and other QA related activities

Supports regulatory agency inspections of Nonclinical activities and inspection readiness activities with an average of 2 inspections/annum

Organizational Context:

Reports to the Director of Research QA

Coordinates QA audit process or activities with RQA management and members

Interaction with departmental staff, e.g. Japan-RQA and QA- counterparts in other cross functions; direct line management in QA, Test Facility Management, functional peer groups (colleagues involved with SOP writing, Central Archiving, and Training Function), relevant staff of Nonclinical-supporting Departments and Vendors/CRO

Requirements

Qualifications:

Required

Bachelor's degree, 5 years' experience in GLP/GXP auditing of internal and external service providers in the pharmaceutical industry or related field

Diverse Quality operations experience across functions in GLP including CRO/CDMO oversight activities

Have strong team skills and the ability to persuade and collaborate effectively

Effective interpersonal skills and multi-cultural/inter-cultural awareness; Demonstrated competence to build strong working relationships with colleagues and stakeholders.

Ability to provide solution minded approach and flexibility to emerging challenges

Domestic and international travel 10-25% as required

Preferred

Project Management Skills or experience

Working knowledge of global regulatory requirements for the Cell and Gene Therapy products

Quality assurance / auditing certification or credentials through recognized quality standards organization

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

#LI-SS

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

Type

Full-time

Location

MA, Westborough

Category

Quality Assurance/Quality Control

Company info

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