Associate Director Quality Control

At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s outstanding skills with those of people from all over the globe.

• Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role.  Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time.  Report potential issues of non-compliance.
• In addition, for Managers and Project Team Leaders:
• Ensure and monitor compliance by team members and third parties by (a) positively reinforcing the Code of Conduct and all relevant AstraZeneca Policies and Standards, (b) ensuring completion of all required training, (c) fostering a culture of openness in which employees are comfortable raising questions or concerns, and (d) immediately addressing and reporting, as appropriate, instances of non-compliance.
• Manager Accountabilities at AstraZeneca include Ethical Conduct and Compliance, Team Management, Performance Management, Individual Development Planning, Talent Management, Recruitment, People information, SHE accountabilities, supervision of employees, performance and career management of employees, strategic and tactical planning, and Fiscal and Financial awareness.
• Leaders with accountability for GXP areas are expected to understand the legal and regulatory requirements of their roles in providing appropriate resources (which could be human, financial, material, facilities, and equipment) to meet customer and business needs.
• Lead the team in a professional manner, providing performance management, coaching, mentoring, direction, and support for team members.
• Ensure that systems and processes owned by the team are in a state of control and are effectively managed and maintained.
• Assign responsibilities to ensure that workload is managed within the team, ensuring effective use of resources.
• Assign and manage roles and responsibilities within team to ensure clear accountabilities and high-level performance that meets or exceeds customer needs.
• Develop, communicate, and deliver tactical plans to enable team to meet or exceed expectations
• Provide feedback to team, and to other teams that interact with team, to assist with building improved performance.
• Lead and assign projects, and other ad hoc tasks and activities
• Ensure timely completion of all Quality System Records (eg… SOPs, DEVs, CAPAs, trending reports, etc) for team.

In addition to the general description of the parent profile role for this job function, the following summarize key result areas, specific accountabilities and / or tasks, etc. associated with this job title include:

• Build a team that is identified as subject matter experts (SMEs) in performance and understanding of biological assays, endotoxin, sterility, mycoplasma, viral testing, and aseptic processing
• Participate in and approve laboratory or process deviations, including laboratory investigations.
• Identify and implement learning and development programs for team members.  Ensure that team skills, knowledge, and experience are appropriate and well-balanced to meet team needs.
• Oversee management of laboratory equipment to ensure regulatory compliance and appropriate availability to meet customer needs.
• Serves as SME and Data Integrity champion for laboratory activities as appropriate.
• Manage the programs for Environmental Monitoring (EM) and/or Product Testing (PT) and release.
• Serve on global teams/forums as appropriate
• Oversee and/or write technical reports supporting statistical analysis of data and trending of lab results.
• Act as a Lean champion, embracing Lean tools and principles and implementing continuous improvement initiatives
• Train others on tasks, processes, and equipment in the labs

Author and approve of quality systems records (eg investigations, CAPAs, SOPs) and technical documents (eg trend reports, qualification and validation documents)

Essential Requirements:

• Bachelor's degree in a Science subject
• 2+ years' experience in a GMP QC Micro lab
• 3+ years' experience in the pharmaceutical industry
• 3+ years' direct or indirect leadership experience

Project Management experience

Desirable for this position:

• 7+ years' QC laboratory experience
• Post-graduate degree such as Masters or PhD in a Science subject
• High level knowledge of QC/QA processes and systems

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.