About this opportunity
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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
Integrity
Innovation
Impact
One Astellas
Accountability
Courage
Sense of Urgency
Outcome Focus
Skills and Capabilities
Organizational Focus
Communications
Capacity Planning
Problem Solving
Negotiations
Teamwork
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Job details
How this role compares
Computed from every other active Quality role in our database, not just this employer's listings.
We currently track 256 comparable Manager Quality roles across 76 biopharma companies.
Salary context
66 of 256 peers report a salary range (USD, annualized)
Peers share this role's job function and a matching or adjacent seniority level -- not necessarily the same therapeutic area or country.
Where these roles are based
Top locations among the 256 comparable roles
+ 27 more countries
Seniority mix
256 of 256 peers have a known seniority level
Therapeutic area mix
1 of 256 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
Notify me about similar jobs
Get an email when we spot other openings like this one – same job function, comparable seniority, roles you'd actually want to see.
How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.