Director LabsQA/Audit Quality Assurance, R&D
AstraZeneca

Job Title: Director LabsQA/Audit Quality Assurance, R&D Quality Assurance

Locations: Office based with Flexibility in Gaithersburg MD or Waltham MA

What are we offering?

Do you want to join a dynamic team and have influence on how Quality Assurance deliver value and assurance to AstraZeneca?

Would you like to work with and influence a wide cross section of partners from all areas of the business?

Would you like to be part of a dedicated team of quality professionals team working across the globe to deliver value adding audits and advice in the research, preclinical and clinical supplier areas?

If so, we have a fantastic opportunity as a Director of LabsQA within R&D Quality Assurance.

Who are QA?

We are the independent second line assurance function for R&D, our mission in Quality Assurance is to achieve enduring excellence in auditing, quality management, quality risk assessment and enhance the R&D quality approach for the benefit of our patients.

What does the role Involve?

As a Director LabsQA you will conduct audits of laboratories both internally and externally at our suppliers. You will enrich the strategic direction of risk audit activities across the North American AstraZeneca and Alexion sites. Reporting to the Senior Director LabsQA you will support inspections and handle CAPAs related to audit and inspection in collaboration with collaborators.

Tell me more?

LabsQA Team are responsible for the strategic development and delivery of a GLP/ lab GCP, HBS and GLS risk-based audit program. This includes the LabsQA Supplier Qualification Assessment process.

LabsQA Auditors are accountable for planning, leading, conducting, and reporting R&D QA audit activities, to current practices in accordance with company policies, standards, SOPs and guidelines.

What skills do I need to do this role?

• Significant Audit experience in pharmaceuticals or a related industry, i.e., laboratories involved in GLP, Lab GCP, HBS and CLIA.
• In depth knowledge of the regulatory requirements associated with the pharmaceutical industry, specifically laboratories.
• Integrity, ethical judgment, and a high standard of professional conduct while maintaining independence and objectivity.
• Excellent analytical and critical thinking ability to assess and clearly communicate risks associated with sophisticated systems and processes
• Effective expressive and receptive communications savvy to include authoring reports and communicating findings to partners with clarity and tact.
• Strong collaboration skills encouraging a concerted team environment and relationship building with partners.
• An appetite for continuous learning and adaptability to the changing technological and regulatory landscapes.

What will I be accountable for?

• Ensuring own tasks are performed to current practices and in accordance with company policies, standards, SOPs and regulatory guidelines.
• Promoting a quality attitude. culture of ethics, integrity and continuous improvement that focuses on delivering efficiencies and business benefits.
• Communicating effectively with QA colleagues and business team members.
• Maintaining a knowledge of relevant industry information affecting GxP, Quality and Compliance.
• Leads training for colleagues and business collaborators as required.
• Involved in and may lead the development and/or revision of QA processes, projects and tools.
• Mentors QA colleagues
• Provides general support related to regulatory authority inspections when required.
• Provides adaptive and proactive quality and compliance advice to partners, reliably influencing assigned area with proficient GxP/quality system.
• Supporting quality and compliance risk management for functional area using risk framework standards to define risk and develop mitigation recommendations.
• Travel expected

Education, Skills and Experience Required:

• Bachelors Degree level education or equivalent experience
• A minimum of five years significant experience in pharmaceuticals or a related industry
• Excellent analytical, written and oral communications skills
• Fluent in written and spoken English
• High ethical standards, trustworthy, operating with absolute discretion
• Strong collaborative, influencing and interpersonal skills - curious to understand business environment
• Skilled at managing & using technology
• Ability to maintain and create professional networks with stakeholders
• Experience in managing regulatory health authority GxP Inspections
• Audit expertise

Education, Skills and Experience Desired:

• Project management experience
• Experience of six sigma/lean/process improvement tool
• Key Account management

I am interested what should I do next?

Are you already imagining yourself joining our team? Good, because we cannot wait to hear from you.

AstraZeneca an Employer of Choice:

At AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society because AstraZeneca embraces diversity and equality of opportunity.

AstraZeneca is 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 offer a competitive Total Reward program including a market driven base salary, bonus and long term incentive. We also provide a generous paid time off program and a wide array of benefits offerings!

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

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.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

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