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 manufacturing 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!
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
