Title:  Manager, Quality Assurance (GCP)

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Manager, Quality Assurance (GCP Audit)

About Astellas

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.

Are you driven to make a real difference in the lives of 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

GCC POLAND: This is a permanent role based in our Global Capability Centre in Warsaw, Poland and hybrid working with the expectation for some office presence. Flexibility may be required in line with business need. Candidates must be located within a commutable distance of the office

Astellas’ Responsible Flexibility Guidelines Statement - 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. Provides technical expertise to identify and resolve quality issues.

Role and Responsibilities

• Leads or supports Clinical Quality Assurance Audit of clinical investigator sites, vendors, Astellas internal systems/procedures, and others as required.
• Assures GCP Compliance with the Astellas Quality Management System (QMS) documents and Regulatory Agency requirements. Identifies issues and supports management of recommended corrective and preventive actions electronically, as needed.
• Supports regulatory inspection preparation for inspections at Astellas, Astellas entities and/or partners across the region and globally, in support of the GQL.
• 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 or equivalent
• Few years’ experiences in pharmaceutical, biotechnology, or related industry and experience in Clinical QA.
• Demonstrable experience in 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

Preferred Qualifications

• GCP auditing experience
• Knowledge of the technology required for Clinical trials

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

Our Organisational Values and Behaviours

Skills and Capabilities