Title:  Manager, Clinical Quality Assurance (CQA)

Astellas’ Global Capability Centres – Overview

Astellas’ Global Capability Centres (GCCs) are strategically located sites that give Astellas the ability to access talent across various functions in the value chain and to co-locate core capabilities that are currently dispersed. Our three GCCs are located in India, Poland and Mexico.

The GCCs will enhance our operational efficiency, resilience and innovation potential, enabling a timely response to changing business demands.

Our GCCs are an integral part of Astellas, guided by our shared values and behaviors, and are critical enablers of the company’s strategic priorities, sustainable growth, and commitment to turn innovative science into VALUE for patients.

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

Working Environment and Location

• This position is based in Mexico City (Santa Fe area) and will require on-site work in a hybrid set up.
  
• At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.

Purpose and Scope

This position works in partnership with Research and Development (R&D) and other business units in support of global and local drug development, registration, and marketing for assigned assets across Therapeutic Areas (TAs) for all stages of drug development.

Collaborates with QA members and R&D for alignment with Company-wide standards and Quality Systems. Ensures Quality oversight of R&D processes and clinical trials (Phase I-IV) to maintain compliance with the international requirements for Good Clinical Practice (GCP) and other relevant (inter)national regulations. 

Responsible for managing, conducting and/or participating in regional/global audits. Under the guidance of a more senior CQA staff member manages external QA resources and provides technical expertise to identify and resolve quality issues

Role and Responsibilities

• Represents CQA as a Global Quality Lead (GQL) on assigned R&D asset/study teams across therapeutic areas. Develops a Clinical Quality Assurance Oversight Strategy for applicable assets to define a plan for quality oversight including projected audits, inspection support, and planned risk assessments.  Performs quality risk assessments, identifies issues, and reviews/approves corrective action plans proposed by functional areas.
• Assures GCP Compliance with the Astellas Quality Management System (QMS) documents and Regulatory Agency requirements.  Identifies issues and supports implementation of recommended corrective action as needed.
• Conducts audits of clinical study sites, vendors, Astellas internal systems/procedures, and others as required.
• Supports regulatory inspection preparation at Astellas entities and/or partners across the region and globally. Analyzes the risks, defines the strategy for inspection readiness and manages the roll out of the inspection readiness program across departments and territories ensuring a harmonized approach.
• Manages quality issues related to Major/ critical nonconformances, suspicion of scientific misconduct and/or potential fraud. Leads proper corrective and preventive actions identification and rolls out and ensures follow up with effectiveness measures.
• Track, trend, and/or report quality metrics to management to assure that Astellas systems and procedures comply with Astellas and external regulatory authority requirements for compliance. Analyzes quality metrics to facilitate the Management Review process and keeps management apprised of critical issues which may impact the success of the organization.
• Supports the development and implementation of process improvements within Astellas R&D QA and R&D functional areas, processes, and systems.  Participates in the periodic review and revision of QMS documents

Essential Qualifications

• Bachelor's degree in sciences
• Minimum of 3 years in pharmaceutical, biotechnology, or related industry
• Minimum of 1 year experience in QA.
• Minimum of 2 years project management/clinical monitoring experience, preferable in a matrixed, global setting, requiring facilitation, negotiation, problem-solving, and conflict resolution skills.
• Understanding GCP requirements and practical experience and understanding of clinical quality assurance as applied throughout the entire pharmaceutical compound/product life cycle.
• Effective oral and written communication and presentation skills in English
• Proficiency in Microsoft Office
• Ability to travel at 20-35 % as required (mainly US) 

Benefits

Careers | Astellas

Why Astellas

• We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas and aren't afraid to take intelligent risks. 
• People who act with unwavering integrity and are deeply committed to making a tangible impact. 

Learn more at Astellas.com