Manager, Quality Assurance (CQA)
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.
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 behaviours, and are critical enablers of the company’s strategic priorities, sustainable growth, and commitment to turn innovative science into VALUE for patients.
Location and Working Environment
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 & 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.
Required 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
What awaits you at Astellas?
- Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
- Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
- Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
- A Culture of Growth: Chart your own cours e within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.
Our Organizational Values and Behaviors
- Impact
- Innovation
- Integrity
- One Astellas
- Accountability
- Courage
- Sense of Urgency
- Outcome Focus
Benefits
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help.
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