Associate Director – External Quality
| Company | AstraZeneca |
|---|---|
| Location | Wilmington, DE, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s |
| Experience Level | Senior |
Requirements
- Holding a bachelor’s degree in scientific/technical field
- Minimum five years of operations or quality assurance experience within Pharma industry, GMP or regulated environment
- Proven leadership and project management/implementation experience record
- Strong demonstrated knowledge of cGMPs/GDPs, Quality Systems, and the pharmaceutical supply chain
- Proven decision-making skills, judgment, and problem-solving skills
- Demonstrated ability to work independently and collaboratively on multidisciplinary and multifunctional teams in the Region and globally
- Strong communication and technical writing skills
- Ability to travel as required approximately 10-20% of the time.
Responsibilities
- Support implementation of AZ Global Standard for GMP and GDP
- Train and educate stakeholders of GDP/GMP
- Implement the Distributor Management Framework and ensure that distributors are authorized/licensed to conduct business related to AZ products
- Implement and monitor processes related to handling of AZ products
- Identify risks and set corrective actions
- Monitor Quality Performance among carriers, Distributors, and DCs
- Establish new distribution routes with novel requirements and adapt to short notice changes (RRA)
- Support qualification of multiple cold chain solutions and associated change control
- Introduce new storage and distribution facilities
- Establish and execute a robust rapid response process for responding to TE and S&L incidents during distribution of AZ products
- Perform and document robust Quality Risk Assessment when deviations from standard processes occur
- Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to GDP/GMP role
- Complete all required training on SABA, Code of Conduct, supporting Policies, and SOPs on time
- Report potential issues of non-compliance
- Ensure and monitor compliance by team members and third parties by: Positively reinforcing the Code of Conduct and all relevant AstraZeneca Policies and SOPs, Ensuring completion of all required training, Fostering a culture of openness where employees are comfortable raising Quality questions or concerns and take action to bridge GDP/GMP quality gaps
- Immediately addressing and reporting instances of non-compliance & Implement (CAPA) Corrective action & preventive actions
- Ethical Conduct and Compliance, and SHE accountabilities
- Understand & Comply with legal and regulatory requirements related to GDP/GMP
- Ensure that GDP/GMP local & global SOPs are followed among team members to ensure GMP/GDP adherence
- Support Audit & Inspections with relevant GDP/GMP documents
Preferred Qualifications
- Previous experience negotiating business and quality contracts
- Global experience
- 5+ years’ experience in Quality Assurance
- Advanced knowledge of cGMP requirements, quality systems, and pharmaceutical manufacturing/packaging technologies
- Advanced degree such as Masters in scientific/technical field, Business, or Quality Assurance/Regulatory Affairs
- Multi-lingual capabilities
- Educational qualification/certification in supply chain management
- Experience of working with a health authority/regulatory body