Associate Director, Audit Quality Assurance
2 weeks ago
Job Title: Associate Director, Audit Quality Assurance
Location: Gaithersburg US or Mississauga CA (3 days on site)
As 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.
Accountabilities:
Audit
- Plans, leads, conducts and reports audits in assigned GxP areas, and types e.g. investigator site audit, system or process audits and vendor audits.
- Participate in and may lead directed (For Cause) audits.
- Works with contract personnel or consultants to prepare, conduct and report outsourced audits
- Supports Due Diligence activities as assigned
- Leads Supplier qualification activities as assigned
- Identify and assess gaps during supplier qualification assessments
CAPA
- Assesses need for, and assists in development of CAPA plans, approves and monitors plans to completion
Inspection
- Provides QA oversight and/or management of regulatory GCP/GVP inspections
- Collaborates with Quality Assurance lead, to handle and prepare for regulatory inspections as assigned including providing training to the organisation as needed.
General Accountabilities
- Ensures own tasks are performed to current practices and in accordance with company policies, standards, SOPs and guidelines
- Promotes a culture of ethics, integrity and continuous improvement that focuses on delivering efficiencies and planned business benefits
- Communicates effectively with QA colleagues and business collaborators
- Maintains knowledge of relevant industry information affecting quality and compliance arena
- Leads training for colleagues and business partners 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 as and when required
- Provides responsive and proactive quality and compliance advice to defined customers, effectively influence assigned area by being relevant GCP/GVP/quality system expert
- Support quality and compliance risk management for functional area using risk framework standards to define risk and develop mitigation recommendations
Essential Skills/Experience:
- Degree level education or equivalent experience
- 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 running & using technology
- Ability to maintain and create professional networks with collaborators
- Supplier qualification
Desirable Skills/Experience:
- Expertise in Data Insights, IVDR/SaMD, Digital
- Project management experience
- Experience in leading regulatory health authority GxP Inspections
- Key Account management
- Audit expertise
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives 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 bold world.
Why AstraZeneca?
Join the team dedicated to Oncology, with an ambition to eliminate cancer as a cause of death. It's our big vision that unites and inspires us. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we keep pushing forward. Fusing cutting-edge science with the latest technology to achieve breakthroughs. Backed by investment, we are aiming to deliver 6 new molecular entities by 2025.
A place built on courage, curiosity and collaboration. we make bold decisions driven by patient outcomes. Empowered to lead at every level, free to ask questions and take smart risks that write the next chapter for our pipeline and Oncology team.
Pioneers of collaborative research we have built an unrivalled scientific community both internally and externally. Fusing academia and industry, we have united some of the world's foremost medical centres. Working seamlessly and inclusively, together we expedite research in some of the hardest-to-treat cancers.
Have the opportunity to build a rewarding and meaningful career as part of the team committed to improving the lives of millions with cancer.
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