Senior SpecialistAssociate Manager, Supplier Quality, QA

Major responsibilities

• Material Qualification: Maintain material introduction procedure and facilitate materials qualification. Establish and maintain phaseappropriate material specification.
• GMP Supplier Management: Own endtoend supplier lifecycle under GMP including qualification compliant supplier change periodic evaluation and decommission based on a risk-based and phase appropriate procedure within expected timeline. CMOs clinical sites service providers and material suppliers are in scope. Maintain an approved supplier list.
• Quality Assurance Agreement: Develop negotiate and maintain quality assurance agreements and product/material specific requirements (if applicable) with suppliers to ensure compliance with GMP and related guidance.
• Audits and CAPA: Develop and execute supplier audit plans. Conduct audits of suppliers to identify potential gaps and risks review observation response and track CAPA implementation.
• Supplier compliant: Initiate complaint to supplier issues. Follow up review supplier investigation and corresponding CAPAs assess the impact on product quality and patient safety.
• CMO Oversight: Oversee all required quality activities during the life cycle of a GxP CMO including but not limited to process/method development and verification/validation facility/equipment commission and maintenance quality risk assessment specification manufacturing testing release deviation and investigation change control product complaint regulatory submission as per established procedure and quality agreement requirements. Participate project meeting as quality representative.
• Clinical Site Inspection: Inspect apheresis collection operation ensure adherence to manuals chain of identify/custody and phase appropriate GCP/GMP requirements.
• QCM Integration: Integrate material qualification and specification with global quality compliance manual (QCM) and procedures at MRCT related sites. Participate in and implement supplier quality related QCM integration at site as stakeholder per project timeline.
• Participate in Quality Management Review product review and corresponding quality review.
• Leads and influences other quality professionals across the organization to ensure consistent application and execution of key quality systems
• Participate in project teams created towards problem solving or specific issues to ensure GMP and regulatory compliance
• Participate in internal self-inspection. Address observations issues or potential risks related to supplier quality define and implement corrective and preventive actions.
• Proactively participates in company initiatives toward continuous improvement (New Products Introduction GMP Improvement Programs etc.) while providing guidance in the area of knowledge and deliver timely results while contributing to quality system improvement.

Education Qualifications Skills and Experience

• Education: Bachelors degree or above in pharmaceutical Chemical. Biology microbiological or related field; Graduates from 985/211 universities institutions are preferred.
• Experience: 7 years of QA QC manufacturing experience within a robust GMP quality system in pharmaceutical with at least 2 years focused on material/supplier quality or external manufacturing/testing oversight in biological products. Experience in Cell Therapy/ATMP is preferred MNC background is a plus.
• Technical Knowledge: Strong understanding of aseptic process contamination control singleuse technologies and risk-based decision-making. Ability to identify and analyze data from variety of sources to drive insights identify root causes and generate solutions.
• Regulations & Standards: In-depth and current knowledge of all relevant GxP regulations and guidance for Pharmaceutical and biotech manufacturing and related activities. NMPA/FDA/EU cGMP know-how and a thorough understanding of ICH PIC/S. Ability to translate requirements into practical SOPs and workflows.
• Skills: Excellent communication skills with both internal teams and external stakeholders strong cross-function coordination capabilities rigorous logical thinking strong documentation aligned with ALCOA. Excellent problem-solving skills project management and drive continuous improvement.
• Language: Well English (spoken and written) able to communicate with global team and author high quality English documentation.
• Behavioral Attributes: Demonstrates strong ownership self-motivation and execution. Excels at problem-solving cross-functional collaboration and prioritization.
• Willingness to travel: Up to 15-20% for supplier audits onsite oversight and patterner governance (clinical sites CMO material suppliers and service providers).

Preferred/Optional

• Experience with QMS systems such as Veeva.
• ASQ quality certifications.
• Leadership skills

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds with as wide a range of perspectives as possible and harnessing industry-leading skills. We believe that the more inclusive we are the better our work will be. We welcome and consider applications to join our team from all qualified candidates regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements.