Associate Director - Manufacturing Electronic Batch Record (MEBR)

About the role

Accountable for establishing and leading the Electronic Batch Record (EBR) capability at site, this role owns how manufacturing processes are translated into practical, executable batch records within MES. The focus is on creating operator-friendly, compliant records that enable efficient batch execution, review-by-exception and accelerated release. The Associate Director leads a dedicated team to create, manage and continuously improve electronic batch records, securing a smooth transition from project and tech transfer into routine GMP manufacturing with a strong emphasis on right-first-time execution and robust data integrity. Working closely with Manufacturing, QA, MS&T/Engineering, Digital/MES and Supply Chain, the role drives performance through clear KPIs while maintaining high regulatory standards. Accountabilities Lead the establishment and long-term ownership of the site's Manufacturing Electronic Batch Record (MEBR) capability within the MES, EBR review, defining the strategy, standards and ways of working Serve as the MEBR owner during Basic Design and Detailed Design phases, ensuring process requirements are accurately captured and translated into executable electronic batch records. Collaborate with Global IT and cross-functional partners to secure timely MEBR readiness for API manufacturing, large molecule manufacturing, aseptic filling and finished packing processes. Ensure a smooth transition from project/start-up and tech transfer into routine GMP manufacturing, removing barriers to adoption and stabilising performance. Drive right-first-time MEBR design concepts that enable efficient batch execution, future batch review and accelerated batch release. Champion compliance with cGMP, occupational safety and local regulatory expectations in all aspects of MEBR design, execution and lifecycle management. Plan, manage and control overall allocation of resources for MEBR creation, revision and review, balancing quality, speed and cost. Streamline and continuously improve the MEBR creation, revision and review process using Lean principles and digital tools. Recruit, develop and lead a high-performing MEBR team, EBR review , collaborate with the QA team to set up a review-by-exception process, ensuring timely review of EBR with improved efficiency and at the right time. Define business needs for MEBR capability, gain stakeholder alignment and translate these needs into specific resource and investment requirements. Coach and mentor team members to build deep expertise in EBR design, GMP documentation and shopfloor execution. Develop senior-level relationships across the site and network to resolve issues quickly, optimize business performance and identify future improvement opportunities. Own and drive KPIs across productivity, quality, safety, schedule adherence and cost for the MEBR area, using data to guide decisions. Lead the continuous improvement culture within the MEBR team and contribute to digital transformation initiatives across manufacturing. Act as a key voice in inspections and audits related to MES/EBR, validation and data integrity, ensuring readiness at all times. Essential Skills/Experience Degree in Engineering, Pharmaceutical Sciences, or related field Strong experience in GMP manufacturing industry within large matrix organization Proven experience in batch record creation, review, and management in a GMP environment Deep understanding of shopfloor operations and process execution Experience working with electronic batch record systems (as a user/owner, not IT developer) Strong knowledge of GMP documentation, data integrity (ALCOA+), and regulatory expectations Demonstrated leadership in transitioning from project/startup into commercial operations Desirable Skills/Experience Advanced Credentials: Master's or MBA; certifications (Lean Six Sigma; Green Belt). Regulatory Engagement: Experience in FDA/EMA/MHRA/NMPA inspections defending MES/EBR, validation, and data integrity. Platform Depth: Advanced skills in PAS-X (master batch records, parameter libraries, review-by-exception workflows). Change Management: Leading adoption, training, and governance/template rollout across site or network. Data & Analytics: Use of EBR data and KPIs for CPV, process capability, and accelerated batch release. Multisite/Global: Collaboration with Global IT and cross-site teams to harmonize standards and deliver to quality/schedule/cost KPIs.

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