Senior Specialist, Operation, QA for Manufacturing

Major responsibilities

• On shop floor quality oversight for cell therapy products to ensure product batch is manufactured according to approved procedure and in compliance with current GMP requirements
• Performs the QA review and approval of the following GMP documentation as it relates to the oversight scope to which the position is aligned:
  • Validation and Qualification documents
  • Deviation Investigation
  • Change control
  • Batch Records and associated documentation
  • Product and material Release
  • Others Quality Investigation (OOS, Complaints, etc.)
  • Standard Management Procedures
  • Standard Operating Procedures
• Leads and influences other Quality professionals across the organization to ensure consistent application and execution of key quality systems
• Performs quality oversight of the utilities and facilities as per defined schedule
• Participate in project teams created towards problem solving or specific issues, to ensure GMP and regulatory compliance
• Participate in internal self-inspection or other audit activities
• Support development and implementation of CAPAs identified from internal audits and regulatory inspection
• Participate in the development and implementation of Quality Risk Assessments related to utility and validation activities
• Participate in quality system reviews and provide appropriate data information
• 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
• Actively identifies, develops, establishes, monitors and maintains area Key Performance Indicators (KPI’s) as required. Take any action needed to prevent situations that may impact the patient safety, quality of the product.

Education, Qualifications, Skills and Experience

• Education: Bachelor’s degree in pharmacy, Life Sciences, Biotechnology or related field; advanced degree a plus.
• Experience: 5+ years in GMP cell therapy, biologics, or sterile manufacturing; proven track record in site oversight. Experience with autologous or allogeneic workflows preferred.
• Technical Knowledge: Strong understanding ofaseptic processing, contamination control, EM programs, sterility assurance, closed‑system operations, single‑use technologies and risk-based decision making.
• Regulations & Standards: Familiarity with CFDA GMP,EU GMP (including Annex 1), PIC/S, US FDA guidance (cell therapy, CGMP), ICH Q7/Q8/Q9/Q10, GAMP 5, ISO 14644, ISPE Baseline Guides, and data integrity (ALCOA+).
• Skills: Excellent problem solving, project management, protocol/report authoring and reviewing, risk assessment, interpersonal and oral and written communication, and meticulous documentation. Ability to deal with problems occurring in the field and make sound,patient‑safety‑focused decisions.
• Behavioral Attributes: Ownership, urgency, collaboration, and a continuous improvement mindset; comfortable working in high‑stakes, inspection‑ready environments.

Preferred/Optional

• Certifications: PMP, Lean Six Sigma, or GAMP qualifications.
• Tools: Experience with MES/eBR, EMS/PMS, QMS platforms.
• Logistics: Willingness to work on‑site, support off‑hours oversight, and travel to vendors/CMOs as needed.

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 authorisation and employment eligibility verification requirements.