Associate Director, Quality & Supplier Excellence

AstraZeneca; Gaithersburg (MD); On-site; USD 130,000 - 194,000; Full time

Benefits offered by this job

Health benefits

401(k) plan

Paid vacation/holidays

Office attendance flexibility

Job summary

AstraZeneca in the United States seeks an Associate Director Quality to lead quality management for external suppliers across Formulation, Fill, Finish & Packing, overseeing supplier assessments, quality systems, and data trending to ensure GMP compliance.

You will collaborate with cross-functional teams, review cGMP documentation, drive improvements, and escalate issues to ensure the right product is delivered into the supply chain on time.

Qualifications

• Bachelor's degree in a science/technical field.
• Proven broad experience in pharmaceutical operations or QA.
• 10 years of experience in a similar role.
• Strong knowledge of cGMPs and Quality Systems.
• Excellent oral and written communication in English and local languages.
• Cross-functional collaboration and leading improvement initiatives.
• Strong problem-solving and negotiating skills.
• Ability to travel nationally and internationally up to 25%.

Responsibilities

• Manage Quality Supplier Management including annual assessments, Quality Agreements, data trending and reviewer improvements.
• Maintain understanding of production processes and quality systems.
• Approve cGMP documentation for suppliers (Change Requests, PQRs, CMC docs, deviations, investigations).
• Collaborate with Quality across the organization to ensure consistent application of key systems.
• Escalate and resolve supplier quality issues to protect the product supply chain.
• Ensure GMP and regulatory compliance during planning, execution and closeout with suppliers.
• Support cost saving initiatives and continuous improvements within Supplier Management.
• Benchmark and apply best practices; liaise with suppliers to enable timely project delivery.

Skills

cGMP knowledge

Quality Systems

Pharmaceutical supply chain

Cross-functional collaboration

Negotiation / influencing skills

Travel availability 25%

Education

Bachelor's degree in science/technical field

Master's degree in QA/Regulatory affairs

Tools

Veeva Vault

Job description

AstraZeneca in the United States seeks an Associate Director Quality to lead quality management for external suppliers across Formulation, Fill, Finish & Packing, overseeing supplier assessments, quality systems, and data trending to ensure GMP compliance.

You will collaborate with cross-functional teams, review cGMP documentation, drive improvements, and escalate issues to ensure the right product is delivered into the supply chain on time.