AstraZeneca Pharmaceuticals LP Quality Lead - Americas Distribution in Wilmington, Delaware
As the Quality Lead, Americas Distribution you will be responsible for the Quality Assurance leadership of Operations distribution processes and suppliers in the region. Accountabilities will include establishing, maintaining and driving continuous improvement of quality management systems, overseeing the quality performance, and supporting GMP/Good Distribution Practices (GDP) capability development. You will be a member of the Regional Quality Assurance leadership team.
As the Quality Lead, Americas Distribution you will be responsible for:
Establishing and monitoring the GMP/GDP standards for distribution within the region.
Ensuring the standards, quality systems, and processes for distribution are in line with AstraZeneca and Regulatory requirements.
Driving adherence with GMP/GDP standards with both internal and external partners.
Supporting GMP/GDP capability development.
Networking with global and regional colleagues, including participating on the global QA Distribution Network, to drive standardization and best practices.
Establishing the framework to stay current on new and changing AZ GDP requirements and regulations.
Influencing Pharmaceutical Organizations/Regulators on proposed changes to legislation related to GDPs.
Establishing the framework for managing temperature excursions, deviations, internal/external complaints, quality agreements, and change controls relating to distribution.
Acting as key Subject Matter Expert for the review of all Field Alert Reports for the US market.
Providing the framework/BPO for the execution and management of US product recalls, as applicable.
Providing strategic QA support for Brand and Supply Chain initiatives related to distribution (i.e. new distribution channels, distribution partners).
Assisting in managing successful GMP/GDP Regulatory Inspections.
Driving resolution and corrective/preventative actions for quality/compliance issues related to the distribution quality system.
Required Skills & Knowledge
Bachelors Degree in the sciences, preferably, biology, chemistry, or related discipline.
Relevant experience managing a quality assurance function within the pharmaceutical industry.
Relevant experience in managing QA/GMP aspects of distribution of pharmaceutical products.
Strong knowledge of GMP/GDP regulations.
Relevant experience managing third party relationships.
Previous experience negotiating business and quality contracts.
Preferred Skills & Knowledge
Masters degree in related field
Participation in external pharmaceutical organizations (e.g. PhRMA, ISPE, PDA)
Extensive knowledge of supply chain principles: GMP, GDP, Regulatory.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.