AstraZeneca
Overview
Are you ready to take on a pivotal role in ensuring the highest standards of quality management for our external suppliers? As an Associate Director Quality, you will oversee quality activities that support the execution of Quality Management for suppliers across various categories, including Formulation, Fill, Finish & Packing. Your role involves managing quality systems, conducting supplier assessments, and interacting with regulatory agencies. You will serve as a subject matter expert, collaborating with cross-functional teams to drive process improvements and ensure compliance with GMP and regulatory requirements. This role aims to make a significant impact on our product supply chain. Accountabilities
Responsible for Quality Supplier Management including but not limited to: Annual Assessments; Quality Agreements; trending and reporting of data; assessing, reviewing and improving quality systems at Suppliers; attendance at Quality and Business Review Meetings. Maintains a high level of understanding of relevant production processes and quality systems. Performs the Quality review and/or approval of cGMP documentation for Suppliers, including Change Requests, Product Quality Reviews or Supplier Quality Review (DMS), CMC documentation (ERV) associated with changes or product establishment at Suppliers, Development and technology transfer documentation, along with related Quality and Regulatory documents. Collaborates with and influences other Quality professionals to ensure consistent application and execution of key quality systems. Responsible for quality issues escalation and resolution at the Suppliers to ensure the right product at the right time is delivered into the Product Supply Chain. Proactively ensures GMP and regulatory compliance during planning, execution and closeout phases of projects at Suppliers. As a member of a Supplier Management team, supports cost saving initiatives, value creation, performance standards, continuous improvements, and issue resolutions at Suppliers. Collaborates with and influences other teams to facilitate process improvements and risk assessments; benchmarks internal and external Quality practices to identify innovative, efficient and effective practices. Stays abreast of evolving regulatory compliance practices and recommends implementation strategies to EQ/AZ site leaders. Collaborates in data analysis and report creation on quality metrics and KPIs. Develops and maintains effective business relationships with Suppliers. Supports External Quality QMS activities, including Site Stability Management System, and manages quality data in systems (e.g., Veeva Vault) as required. Contributes to AZ quality documentation and participates in EQ self-inspection processes. Maintains understanding of technical production processes and quality systems within External Supply & Manufacturing (ESM) and External Quality (EQ) organisations. Accountable for Quality decision-making; provides coaching and direction to the Supplier Management Team. Ensures GMP and regulatory compliance. Plans for and participates in Regulatory Agency inspections of Suppliers and AZ sites. Performs Quality Audits as needed within their technology area as a Guest Auditor on the GQA lead audit team. Serves as EQ representative on Issue Management Teams. Provides expert Quality input to NPI, Asset Strategy and/or Value Delivery projects, including supplier identification and regulatory approval support. Liaises with Suppliers to ensure successful delivery of projects. Makes decisions and advises the Supplier Management Team on quality and pharmaceutical technology issues within their area of expertise. Essential Skills/Experience
Bachelor's degree in a science/technical field (e.g., Pharmacy, Biology, Chemistry, Engineering). Note: there may be country-specific requirements. Proven broad experience in either pharmaceutical operations or pharmaceutical Quality Assurance. 10 years of experience in a similar role. Strong knowledge of cGMPs, Quality Systems, and the pharmaceutical supply chain; understanding of pharmacopeia, ISO standards, etc. Excellent oral and written communication skills in English and local languages. Experience working cross-functionally and managing significant improvement initiatives (project management). Strong problem-solving skills and ability to work independently. Ability to travel nationally and internationally up to 25% of time. Experience in a PCO/PET organization or Lean/Six Sigma training is desirable. Multi-site/multi-functional experience. Proven experience in Quality Assurance or a combination of Quality and Technical. Master's Degree in Quality Assurance/Regulatory Affairs or related advanced scientific field is desirable. Desirable Skills/Experience
Experience in Lean/Six Sigma or related continuous improvement frameworks. Additional multi-site exposure and cross-functional project leadership. Compensation and Benefits
The annual base pay ranges from 124,100.80 to 186,151.20 USD. Details on benefits, overtime eligibility, incentive programs, and retirement plans are provided to offer recipients a comprehensive compensation package. Offers are made in accordance with company policy and applicable laws. Company note
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person work is common, with a minimum expectation of three days per week in the office, while maintaining flexibility. At AstraZeneca, you will be part of a dynamic, inclusive environment focused on quality, growth, and collaboration across diverse teams. Ready to take your career to new heights? Apply now to join AstraZeneca's journey towards excellence! Date Posted
03-Sept-2025 Closing Date
18-Sept-2025 EEO Notice
Our mission is to build an inclusive environment with equal employment opportunities for all applicants and employees. If you require accommodations due to a disability or special need, please indicate this in the application form. About the company
AstraZeneca PLC is a British-Swedish multinational pharmaceutical and biopharmaceutical company with its global headquarters in Cambridge, England. Notice
Talentify is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. Reasonable accommodations are provided on request.
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Are you ready to take on a pivotal role in ensuring the highest standards of quality management for our external suppliers? As an Associate Director Quality, you will oversee quality activities that support the execution of Quality Management for suppliers across various categories, including Formulation, Fill, Finish & Packing. Your role involves managing quality systems, conducting supplier assessments, and interacting with regulatory agencies. You will serve as a subject matter expert, collaborating with cross-functional teams to drive process improvements and ensure compliance with GMP and regulatory requirements. This role aims to make a significant impact on our product supply chain. Accountabilities
Responsible for Quality Supplier Management including but not limited to: Annual Assessments; Quality Agreements; trending and reporting of data; assessing, reviewing and improving quality systems at Suppliers; attendance at Quality and Business Review Meetings. Maintains a high level of understanding of relevant production processes and quality systems. Performs the Quality review and/or approval of cGMP documentation for Suppliers, including Change Requests, Product Quality Reviews or Supplier Quality Review (DMS), CMC documentation (ERV) associated with changes or product establishment at Suppliers, Development and technology transfer documentation, along with related Quality and Regulatory documents. Collaborates with and influences other Quality professionals to ensure consistent application and execution of key quality systems. Responsible for quality issues escalation and resolution at the Suppliers to ensure the right product at the right time is delivered into the Product Supply Chain. Proactively ensures GMP and regulatory compliance during planning, execution and closeout phases of projects at Suppliers. As a member of a Supplier Management team, supports cost saving initiatives, value creation, performance standards, continuous improvements, and issue resolutions at Suppliers. Collaborates with and influences other teams to facilitate process improvements and risk assessments; benchmarks internal and external Quality practices to identify innovative, efficient and effective practices. Stays abreast of evolving regulatory compliance practices and recommends implementation strategies to EQ/AZ site leaders. Collaborates in data analysis and report creation on quality metrics and KPIs. Develops and maintains effective business relationships with Suppliers. Supports External Quality QMS activities, including Site Stability Management System, and manages quality data in systems (e.g., Veeva Vault) as required. Contributes to AZ quality documentation and participates in EQ self-inspection processes. Maintains understanding of technical production processes and quality systems within External Supply & Manufacturing (ESM) and External Quality (EQ) organisations. Accountable for Quality decision-making; provides coaching and direction to the Supplier Management Team. Ensures GMP and regulatory compliance. Plans for and participates in Regulatory Agency inspections of Suppliers and AZ sites. Performs Quality Audits as needed within their technology area as a Guest Auditor on the GQA lead audit team. Serves as EQ representative on Issue Management Teams. Provides expert Quality input to NPI, Asset Strategy and/or Value Delivery projects, including supplier identification and regulatory approval support. Liaises with Suppliers to ensure successful delivery of projects. Makes decisions and advises the Supplier Management Team on quality and pharmaceutical technology issues within their area of expertise. Essential Skills/Experience
Bachelor's degree in a science/technical field (e.g., Pharmacy, Biology, Chemistry, Engineering). Note: there may be country-specific requirements. Proven broad experience in either pharmaceutical operations or pharmaceutical Quality Assurance. 10 years of experience in a similar role. Strong knowledge of cGMPs, Quality Systems, and the pharmaceutical supply chain; understanding of pharmacopeia, ISO standards, etc. Excellent oral and written communication skills in English and local languages. Experience working cross-functionally and managing significant improvement initiatives (project management). Strong problem-solving skills and ability to work independently. Ability to travel nationally and internationally up to 25% of time. Experience in a PCO/PET organization or Lean/Six Sigma training is desirable. Multi-site/multi-functional experience. Proven experience in Quality Assurance or a combination of Quality and Technical. Master's Degree in Quality Assurance/Regulatory Affairs or related advanced scientific field is desirable. Desirable Skills/Experience
Experience in Lean/Six Sigma or related continuous improvement frameworks. Additional multi-site exposure and cross-functional project leadership. Compensation and Benefits
The annual base pay ranges from 124,100.80 to 186,151.20 USD. Details on benefits, overtime eligibility, incentive programs, and retirement plans are provided to offer recipients a comprehensive compensation package. Offers are made in accordance with company policy and applicable laws. Company note
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person work is common, with a minimum expectation of three days per week in the office, while maintaining flexibility. At AstraZeneca, you will be part of a dynamic, inclusive environment focused on quality, growth, and collaboration across diverse teams. Ready to take your career to new heights? Apply now to join AstraZeneca's journey towards excellence! Date Posted
03-Sept-2025 Closing Date
18-Sept-2025 EEO Notice
Our mission is to build an inclusive environment with equal employment opportunities for all applicants and employees. If you require accommodations due to a disability or special need, please indicate this in the application form. About the company
AstraZeneca PLC is a British-Swedish multinational pharmaceutical and biopharmaceutical company with its global headquarters in Cambridge, England. Notice
Talentify is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. Reasonable accommodations are provided on request.
#J-18808-Ljbffr