Overview
Head of Development Product Quality Assurance, AMR Jobs in Northbrook, Illinois, USA at Astellas Pharma
Head of Development Product
Quality Assurance
, AMR
Join to apply for the Head of Development Product Quality Assurance, AMR role at Astellas Pharma.
This position is based in Northbrook, Illinois, with potential for remote work depending on location.
Purpose
and Scope
The Head of Development Product QA (AMR) reports to the Head of Product QA and is a key member of the Product QA Leadership Team. This role involves creating and executing the QA strategy, overseeing staff, processes, and systems for Clinical Trial Material (CTM) activities, and ensuring compliance with GMP and regulatory standards across global supply chains.
Responsibilities
Lead the Development Product QA (AMR) function to ensure high quality and continuous supply of CTM products.
Develop and implement strategic plans for regional and global QA activities.
Maintain strong collaborations with internal and external stakeholders, including CMOs and regulatory bodies.
Manage and develop the QA team, ensuring high performance and professional growth.
Oversee quality systems, audits, regulatory inspections, and risk management activities related to CTM.
Ensure compliance with all applicable GMP, GDP, and other regulatory requirements.
Handle quality issues, deviations, complaints, and change controls related to CTM.
Prepare for and participate in regulatory inspections and audits.
Qualifications
BSc in a science-related field with 8-10+ years of pharmaceutical industry experience related to CMC, GMP, QC, or QA.
At least 2 years of direct people management experience.
Extensive knowledge of GMP regulations, quality principles, and industry trends.
GMP auditing experience across various modalities and manufacturing steps.
Strong communication, interpersonal, and influencing skills.
Ability to develop relationships with stakeholders and represent the company during audits and inspections.
Preferred Qualifications
Leadership experience in a similar role.
Experience in manufacturing operations and global regulatory standards.
Benefits
Comprehensive health insurance, paid time off, 401(k) matching, and other perks.
Astellas is committed to diversity and equal opportunity in employment.
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Title: Head of Development Product Quality Assurance, AMR
Company: Astellas Pharma
Location: Northbrook, Illinois, USA
Category: Quality Assurance – QA/QC (Data Analyst)
