Operational Quality Specialist - MES

About this role

Business Introduction:

We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply. We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.

Position Summary:

To ensure adherence to cGxP standards and procedures through the independent oversight of GxP processes. To improve the effectiveness of quality in preventing /identifying and addressing quality issues by encouraging proactive quality culture and continuous improvement. Directly support Operational through development, review, and approval of MES related design, implementation and performance management tasks. You will provide operational quality assurance for Manufacturing Execution System activities that support drug product manufacturing. You will work closely with manufacturing, engineering, IT, and quality teams to keep processes compliant and data trustworthy. We value clear decision makers who coach others and act with integrity. This role offers hands-on learning, visible impact, and clear career growth aligned with our mission of uniting science, technology and talent to get ahead of disease together.

Responsibilities:

• Provide operational QA oversight for MES workflows, electronic batch records, and system-controlled manufacturing steps.

• Ensure that all GMP processes and operational personnel adhere to current GMP, validation, quality, safety and environmental regulations are met maintaining inspection readiness at all times.

• Review eCC, TCD and/or other QS change for impact to: Master Data (Equipment, sMBR, Workstations, Workcenters). Main-PI, Sub-PI design/validation

• Review and approve creation and/or updates to master data:

• Equipment Spec File (as QA Master Data) sMBR (as sMBR QA Reviewer) including integration with SAP and OsiPi

• Review and approve creation and/or updates to URS and Design of Main-PI, Sub-PI (as QA PI Reviewer and QA Ops, as applicable) Including integration with SAP and OsiPi

• Approval of Validation Form for Main-PI, Sub-PI pre and post-execution (as QA PI Reviewer) including applicable incident management and including integration with SAP and OsiPi

• GxP, DI, Business Continuity Risk Assessments, PI inventory

• IO/PQ protocol and report, including applicable validation impact assessment/unplanned events (as QA PI Reviewer and QA Ops, as applicable). Audit Trail Reviews

• Develop/Approve MES LSOPs and associated child documents

• Provide review, initial impact approval, and final approval of devations and associated CAPA plans, logbooks, PQRs, customer complaint investigations, change controls, validation documents, etc.

• Role model the GPS standards and foster a ‘Quality Starts With Me’ culture by providing coaching to employees on the importance of following procedures, doing the right thing and explaining the why and the impact non-compliance can have on product quality and patient safety.

• Perform regular shopfloor and system walkthroughs to identify risks and coach teams on good documentation and data integrity.

• Lead or support investigations for deviations, system incidents, and data anomalies, including root cause analysis and CAPA follow-up. Review and approve change controls, validation summaries, and procedural updates that affect MES or digital records.

• Support inspection readiness, internal audits, and regulatory questions related to computerized systems and digital records.

• Monitor MES-related quality KPIs and trends and recommend process or system improvements.

Basic Qualifications:

• Bachelor’s degree in Life Sciences, Biology, Chemical Engineering. A bachelor's degree in other disciplines may be acceptable if sufficient technical depth has been achieved from experience.

• Minimum 3 years' experience in regulated industry preferably in Quality Assurance.

• Must have prior MES implementation experience.

• Requires understanding and experience with pharmaceutical facility, equipment and systems. Including technical understanding of industry and science practices related to the business in order to apply knowledge to daily activities.

• Experienced with GMP’s, NIH Guidelines, FDA and other regulatory agency compliance requirements sufficient to apply to quality operations and compliance, with knowledge of validation principles, aseptic processing, quality systems and FDA regulations.

• Training and work experience in DMAIC root cause analysis methodology.

• Must have 1 + year of hands-on experience with Good Manufacturing Practices and Good Documentation Practices.

Preferred Qualifications:

• Experience in biologics manufacturing preferred.

• Familiarity with electronic records guidance such as 21 CFR Part 11 or Annex 11.

• Hands-on experience supporting system validation (IQ/OQ/PQ) or computerized system lifecycle tasks.

• Experience with LIMS, electronic batch records, or other digital manufacturing solutions. raining and work experience in DMAIC root cause analysis methodology.

• Well-developed interpersonal skills and decision-making capabilities with the ability to influence different levels of the Site and Quality organization. Ability to deliver clear communications (written and verbally), coaching, foster a ‘Quality Starts with Me’ culture and work with a spirit of continuous improv

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