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Senior Manager Quality Control

2 months ago

Coppell, United States National Black MBA Association Full time

Introduction to Role: Are you ready to provide technical and analytical leadership, advice and direction to the Quality Control function including instrumentation and methodology troubleshooting, non-routine analysis, and the evaluation and maximization of technology. The individual should be qualified to graduate level or equivalent in a scientific subject area, with experience working in a GMP manufacturing or laboratory environment. Will have strong knowledge and understanding of analytical chemistry and laboratory instrumentation, as well as Good Manufacturing Practice/Good Laboratory Practice. Additionally, must be proficient in Lean 6 Sigma and the application of Lean in the laboratory environment. Responsible and accountable for the throughput in the QC laboratories to support business demands. Accountabilities: Key Accountabilities: Deliver QC operational performance. Ensure QC capacity and capability is in place to meet demand, ensuring all vital testing is carried out. Work as part of the Americas and Global QC network to standardise ways of working, share standard process and integrate into the AstraZeneca supply network. Provides analytical guide knowledge and support to the Quality Control Function for the most complex troubleshooting issues, novel situations and oversees the delivery of initial and ongoing training and mentoring. Optimises performance of direct reports and ensures individuals understand the contribution they make. Approves and monitors contract analysts. Oversees the analytical technology transfer of Quality Control methodology into and out of Operations. Approves specifications, sampling instructions, test methods and other QC Procedures. Ensures appropriate validation has been conducted. Leads and directs the introduction of new technology, coordinates and leads initiative to ensure that Quality Control remains contemporary and driven. Checks the maintenance status of the department, premises and equipment Follows AZ’s financial policies, runs people resources to policy requirements and delivers the QC budget. Monitors and maintains compliance in accordance with cGMP, SHE ,SOX and business procedures. Is accountable for ensuring compliance is understood and maintained across the QC labs. Uses knowledge to support regulatory inspections where required Delivers of a Lean and Agile work culture in the lab environment emphasizing continuous improvement. Safety, Health and Environment Promoting an environment of no hurt, harm or alarm Work in a manner which promotes the safety and well being of self, others and environment Improve SHE performance, proactively use AZ SHE System to identify SHE hazards and take appropriate actions GMP / Compliance and Ethical Conduct Ensuring compliance of self and others to internal and external regulations. Align with all processes and procedures in line with statutory/ legislative / quality requirements. Conduct activities and interactions consistent with our values and in compliance with the Code of Ethics and supporting Policies and Standards relevant to your role. Report potential issues of non-compliance. Ensure and supervise compliance by team members and third parties by (a) positively reinforcing the Code of Ethics and all relevant AstraZeneca Policies and Standards. Manager Accountabilities at AstraZeneca include Ethical Conduct and Compliance, Team Management, Performance Management, Individual Development Planning, Talent Management, Recruitment, People information, SHE accountabilities, and Fiscal and Financial awareness. Leaders with accountability for GXP areas are encouraged to understand the legal and regulatory requirements of their roles in providing appropriate resources (which could be human, financial, material, facilities, and equipment) to maintain the Quality system and continually improve its efficiency. Optimising performance outcomes of and ensuring understanding of contribution within the PCO organization. Delivery / Supply Ensuring customer service is always considered. Cost Promoting a cost conscious environment to enable effective cost management. Lean & Agile Culture Ensure all work conducted in accordance to approved and established processes. Essential Skills/Experience: -Bachelor’s degree in a science, technical or engineering. Minimum of 7 years of proven experience in the

pharmaceutical

m anufacturing

industry, in management and leadership positions. Proven Lean experience and understanding. Advanced knowledge of cGMP requirements, quality systems, applicable to the QC Operations Proven leadership skills; ability to engage direct and indirect reports and peers. Strong written, oral, interpersonal, and presentation skills and the ability to effectively work with all levels of management and staff. Must be willing to address emergent factory quality and compliance issues by being available via telephone during off hours. Desirable Skills/Experience: Prior experience in quality control or laboratory environments Advanced degree, Masters or higher Multiple site or function experience Demonstrated ability to influence leaders in a matrix environment and courageous decisions to ensure patient safety and to protect company reputation. Prior experience in quality control or laboratory environments Advanced degree, Masters or higher Multiple site or function experience Demonstrated ability to influence leaders in a matrix environment and courageous decisions to ensure patient safety and to protect company reputation. Are you ready to face the unexpected every day? Join us at AstraZeneca where you'll be supported to navigate our constantly evolving manufacturing environment. Apply now to be part of our journey towards better health Date Posted 03-Jul-2024

Closing Date Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law. #J-18808-Ljbffr