Anton Birman

• Senior Leadership Team – Quality & Continuous Improvement
  
  As a member of the Senior Leadership Team, I drive quality excellence and continuous improvement across the organization. Partnering closely with customers and corporate leadership, I ensure compliance with regulatory requirements while fostering a culture of accountability and innovation.

Key Responsibilities:

• Lead and host internal and external inspections, ensuring strong audit readiness and compliance.

• Manage customer complaints, driving thorough investigations and effective CAPA processes to prevent recurrence.

• Develop, implement, and enhance Quality Management Systems (QMS) in alignment with regulatory standards (ISO 9001, FDA, HACCP, GMP) and customer expectations.

• Lead, coach, and develop a high-performing quality assurance team in inspections, audits, and process evaluations.

• Partner cross-functionally to address quality issues, conduct root cause analysis, and implement sustainable corrective and preventive actions.

• Define and monitor quality KPIs, analyzing the cost of quality and implementing data-driven improvement plans.

• Oversee supplier quality through evaluations, audits, and performance standards to ensure material and component integrity.

• Deliver training and guidance on quality systems, standards, and best practices to all levels of the organization.

• Conduct internal and external quality audits, identifying compliance gaps and opportunities for continuous improvement.

As a member of the Senior Leadership Team, I ensure compliance with regulations and Baxter global processes to implement an effective Quality System. I manage a team of Quality professionals and collaborate with others to pursue Right First Time at sterile product manufacturing facility. I also manage third-party manufacturing customers, identify product improvement opportunities, and make informed decisions based on data and inputs from Subject Matter Experts.

Responsibility for: Department finance, Documentation Management, Training Program, the Nonconformance (NCR) Handling Process, the Corrective and Preventive Actions (CA/PA) Process, Complaints Handling Process, Annual Product Quality Review, Internal Audit Program, the Quality Management Review Process, the site Inspection Readiness Process, and the Quality Assurance/ Oversight of the Quality Control Laboratories, Change Control process and the Supplier Quality process.

• Quality Specialist covering most of the Quality Systems areas such as Complaints, Quality approver for NCR, CAPA, Change Control, Documentation management, and Lab
• Investigations, Field Action site representative, and Plant Risk management
• As part of the Inspection readiness team, assist in collecting all relevant documentation, coordinate SMEs, and combine observation responses in case required
• Lead for Quality in the QC Labs and oversee all QC activities from a quality assurance perspective
• Reporting directly to site QMR, assisting with plant-related tasks/activities.

• Assure that QC records are compliant with methods, protocols, specifications, and the company's SOPs
• Identify and lead the improvement of SOPs, analytical methods, protocols, and forms
• Provide industry quality and regulatory guidance on non-routine matters, ensure records of Validation/Method Transfer/Verification and reports are as per protocol
• Assure that OOS investigations are performed according to local SOPs
• Consults QC Investigator and review OOS investigations according to local SOPs and regulatory requirements
• Input data for trending of departmental KPls
• Identify, support, and often lead operational improvement initiatives while facilitating stakeholder negotiation and alignment
• Participate in regulatory and client audits as process owner and/or SME.

• Supervisor of a team of 11 analysts in Product dedicated cluster
• Team performing analysis of Raw material to final product including in process Control testing
• Perform work scheduling and troubleshooting, leading the team to performance excellence and release of the product in a timely manner
• Leading OOS/Lab
• Related investigations to closure, performing root cause analysis and initiating/closing CAPAs using different tools such as 6 Sigma/fishbone analysis/ 5 whys, etc
• Working with different departments ( Production facilities, R&D, QA), performing employee SOP/GMP training and performance evaluation
• Conducting cross-QC team internal audits and assisting with identifying the root cause and correction of the observations.

• Conduct quality control tests
• Open OOS/LIR Investigation if required
• Document the test outcome in a timely manner and as per local SOPs and GMP requirements
• Review documentation of other employees and make corrections if required
• Work with a wide variety of QC instrumentation such as HPLC, GC, IC, UV, IR, KF, and more.

• Process Engineer at an organic waste treatment facility
• Project to improve facility yield and environmental condition (airflow, bacteria efficiency, etc.