ANKUR PATEL

• CMO Relationship Management: Manage CMO relationships from a quality and compliance perspective, including monitoring quality metrics, performing annual risk assessments, and executing oversight as defined by SOPs. Author and execute Risk Mitigation Plans as needed.
• Product Disposition and Compliance: Determine the disposition of drug products according to BMS and regulatory specifications and standards. Review and approve change requests generated internally or by External Manufacturers.
• Quality Reviews and Investigations: Review Annual Product Quality Reviews (APQRs) authored by Contract Manufacturers/Packagers and supplement APQRs as required. Investigate and/or evaluate manufacturing and packaging deviations or incidents and associated Corrective and Preventive Actions (CAPAs). Provide direction and recommendations for future actions.
• Quality Agreements and Protocols: Review and approve Quality Agreements, product quality complaint investigations, and validation/qualification protocols and reports from External Manufacturers as defined in related Quality Agreements.
• SOP Management and Regulatory Compliance: Write, review, and implement SOPs to ensure compliance with current BMS standards and cGMP. Represent Bristol Myers Squibb during FDA/other regulatory inspections and corporate GMP compliance audits. Assist with the preparation of audit observations and participate in audits (For Cause) of North American External Manufacturers.
• Cross-Functional Team Representation: Represent Quality on cross-functional teams within the "Virtual Manufacturing Plant," Technical Transfer teams, Supplier Selection, Serialization, Manufacturing, and Packaging launch teams.

Achievements:

• Quality-to-Quality Meetings: Initiated and led weekly meetings with partners to address and streamline quality-related topics, improving resolution times and aligning with business core values.
• Process Improvement Projects: Co-led the complaint process mapping initiative to simplify and remove redundant steps, saving numerous hours during the APQR process and improving efficiency across different Virtual Plant Teams (VPTs).
• Timely Batch Disposition: Ensured on-time release of batches for CMOs by timely review and release by team members, meeting business demands and continuity. Tracked and updated team members on the on-time release matrix.

• Quality Systems Expertise: Provided support as a Subject Matter Expert in quality systems, including validation principles, risk assessment, FMEA, engineering design, and statistical process control fundamentals.
• Strategic Collaboration: Collaborated with Global Operations on strategic business direction and decisions, including moderate and complex risk quality review/approval to ensure compliance with SOPs, industry standards, and regulatory requirements.
• Cross-functional leadership: Led EDMS and QMS cross-functional subject matter expert forums for continuous improvement. Performed quality review and approval of internal and third-party deviations, laboratory investigations, change requests, and CAPAs.
• Partnership Building: Built and maintained strong partnerships with other site and functional leaders to ensure alignment around strategic projects and day-to-day activities, fostering mutually successful working relationships.
• Agile Leadership: Acted as a role model for Agile Leadership behavior by leading quality monitoring activities in all production, packaging, and warehouse areas to ensure quality and compliance for products, processes, and batch documentation.
• Performance Tracking: Tracked and trended performance against quality metrics and statistical reports for management reviews, identifying site-specific concerns and opportunities for improvement (OFI).
• Regulatory Communication: Communicated significant quality or regulatory issues and risks that may impact product quality or regulatory compliance on time to Executive Management.
• Audit Leadership: Led and supported internal audits and GMP/Gemba walk-throughs of manufacturing facilities, analytical laboratories, engineering (facilities), and warehouses to sustain inspection readiness.
• Process Enhancement: Independently led the enhancement of processes, complex projects, and workshops as the Quality lead using Six Sigma methodologies.

Achievements:

• Human Error Reduction Project: Managed the implementation of Electronic Batch Records (EBR), reviewing over 350 investigations and evaluating different failure modes. This project reduced time, resources, and costs, saving approximately 1,052 hours.
• SOP Streamlining: Streamlined 12 different QC testing SOPs and 6 forms into one document, simplifying the process, and removing redundant steps, and non-value-added requirements. This initiative saved significant time and effort, earning the Henry Erlich Innovation Award for Roche Global Operational Innovation in 2018.
• Batch Disposition Cycle Time Reduction: Controlled and supported a cross-functional team project to reduce batch disposition cycle time for drug products manufactured at Contract Manufacturing Organizations. Improved the process by eliminating waste, resulting in a 53% reduction in conditional release cycle time and a 37% reduction in final batch disposition cycle time, leading to resource savings and on-time delivery of the final product.

• Team Leadership and Performance: Led, coached, and mentored 12+ IPQA Associates across 3 shifts in a controlled substance manufacturing/packaging environment and offsite receiving facility.
• Quality and Compliance Oversight: Managed Deviations, CAPAs, Change Control, and product quality complaints, ensuring timely closure. Executed validations (IQ/OQ/PQ) for new and existing equipment and processes.
• CMO Relationship Management: Oversaw contract manufacturing operations, ensuring adherence to quality standards. Implemented change controls, reducing non-conformance rates by 18%.
• Continuous Improvement: Supervised APQRs and managed statistical quality trends, driving continuous improvement initiatives that enhanced product quality and stability.

• Batch Record Management: Led the review and disposition of API, intermediates, and finished products, ensuring timely release and GMP compliance.
• Regulatory Compliance: Represented BMS during regulatory inspections and audits, ensuring successful outcomes and strengthening regulatory relationships.
• Corrective Actions Oversight: Developed and implemented CAPAs, improving deviation resolution times by 30%.
• Interdepartmental Coordination: Facilitated coordination between Product Development, Supply Chain, and Regulatory Affairs, optimizing QA processes and supporting a 20% increase in project turnaround time.

• Managed External Partners to ensure products manufactured/packaged for Hikma met regulatory requirements.
• Built robust communication channels with internal and external partners to achieve organizational objectives.
• Reviewed and approved Deviations, Investigations, CAPAs, and Change Controls.
• Led batch documentation release, adhering to company procedures, specifications, and regulatory requirements.
• Supervised projects transferring new products from development to manufacturing (process scale-up, equipment, packaging, and shipping validation).
• Identified the root cause of product functionality failure, optimized processes, and avoided manufacturing shutdown.
• Validated packaging parameters to reduce reject rates and meet customer delivery commitments.