Regional Logistic Quality Manager, Asia Pacific

Regional Logistic Quality Manager, Asia Pacific

At AstraZeneca, our work in Quality is important and valued. We have an unrivalled forward-looking mindset, continuously innovating to find new and better ways to ensure we are improving outcomes for patients. We take Quality seriously, drawing learnings from others to develop and understand what it takes to drive our modern mindset forward. Here you'll feel empowered to step up, follow the science and evidence to make decisions that put patients first. We are a team of ambitious people, who want to go far and we're all here to achieve.

Join us as a Regional Logistic Quality Manager, this is an opportunity to champion a mindset of excellence in an environment where good can always be better.

About AstraZeneca and AstraZeneca Vietnam

AstraZeneca

AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit AstraZeneca.com and follow the Company on Twitter @AstraZeneca.

Role background

The incumbent works closely with the AsiaPac Distribution Team and other Global Supplier Chain Quality Teams to support the performance of required QA activities within Asia Distribution and AstraZeneca Distribution Facility, and act as the QA leader for the management of assigned External Suppliers and AstraZeneca owned distribution facility within the team ensuring all GDP aspects are met.

Typical Accountabilities:

• They are responsible for QA activities that support execution of Quality Management of Suppliers with regard to Distribution. This includes the Quality System management and the performance of the following activities: QA audits, change control, product quality complaint and deviation investigations, quality issue management and escalation, product disposition, QA Agreements (establishment and maintenance) between AZ and External Suppliers and between ASIAPAC Distribution, Marketing Companies and AZ Operations Sites. This position requires strong cross-functional ways of working with non-QA members in the team.
• This role also takes the responsibility to ensure the compliant quality management system set up and operated in AstraZeneca Distribution Facility, including and not limited to quality audits, change control, product quality complaint and deviation investigation, Training, Facility management, Calibration and Validation, Supplier Management, Package Conversion.
• This role will apply proven analytical and problem-solving skills. Provide QA oversight for / implement validation of equipment and processes. Support/enhance the benefit of business investments in operation initiatives and driving improvement in QA systems/processes. Acting as the quality Approval / Decision maker for the GxP relevant procedure in AstraZeneca Distribution Facility. Ensure the compliance with internal AstraZeneca requirement and also relevant market Healthy Authority Requirement.
• Ensure the quality business as usual (BAU) activities supporting the AstraZeneca Distribution Facility is well arranged and implemented, and accurately quality oversight was also provided. include but not limited to quality control check for inbound and outbound shipment, document management, training, temperature mapping, pack conversion and etc.
• In addition, the preparation and submission of periodic Supplier Quality Assessments and performance the incumbent will also act. as the QA leader on new supplier introductions, projects, process optimization within ASIAPAC Distribution. Regulatory Agency interactions include assisting in the preparation for and management of Regulatory Agency inspections at External Suppliers and AZ Sites (when external suppliers are within the inspection’s scope).
• At the highest level, this position provides support to Distribution team members, working closely with the Distribution Managers (DM) and supporting QA and cross-functional team members during issue resolution.
• To ensure application of Quality Assurance and GDP’s associated with Pharmaceutical Product distribution and related controls.
• In relation to GDP or other relevant quality standard, ensure compliant distribution for new and existing AstraZeneca Pharmaceutical Products through internal and external assets and partners. The QA management includes;
• Assessment, review and improvement of Quality Systems at Distributors and AstraZeneca Distribution Facility.
• Quality Assurance Audit Program management including but not limited to the following:
• Ability to be a “guest” Lead Auditor for GQA, or as audit team member support, QA/Compliance/GDP audit planning, execution.
• Assess against regulatory agency & AZ quality/compliance standards, at Suppliers and AstraZeneca Distribution Facility, and ensure the delivery of the corrective actions/improvement opportunities as part of audit follow-up.
• Ensure audit plan is agreed with GQA for suppliers and AstraZeneca Distribution Facility, in collaboration with Lead Auditor.
• Perform Quality & Compliance assessments of potential suppliers to AZ and provide QA approval of the Supplier, based on their Quality and Compliance capabilities.
• Provide expert QA input to, Asset Strategy and/or Value Delivery projects. This includes identifying and assessing Suppliers
• Liaise with key customers in Operations to ensure successful delivery of projects
• Make decisions and advise the function regarding quality issues
• Responsible for Quality Assurance Supplier Management including but not limited to:
• Quality Assurance Agreements;
• trending and reporting of data;
• assessing, reviewing and improving quality systems at Suppliers
• attendance at Quality Review Meetings
• Collaborates with and influences other Quality professionals across the organization to ensure consistent application and execution of key quality systems
• Interfaces with applicable site support groups on projects (capital and non-capital) that impact distribution, and proactively ensures GDP and regulatory compliance during the planning, execution and closeout phases of these projects
• As a member of the distribution team , responsible for supporting cost saving initiatives, value creation, performance standards, continuous improvements, and issue resolutions with a portfolio of Suppliers
• Collaborates with, and influences, other team members to facilitate process improvements and risk assessments; benchmarks internal and external QA practices to identify innovative efficient and effective practices
• Collaborates in data analysis and report creation on quality metrics and key performance indicators
• Develops and maintains effective business relationships with Suppliers / AstraZeneca Distribution Facility and AZ receiving sites
• Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to the role. Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time. Report potential issues of non-compliance.
• Ensure and monitor compliance by team members and third parties by (a) positively reinforcing the Code of Conduct and all relevant AstraZeneca Policies and Standards, (b) ensuring completion of all required training, (c) fostering a culture of openness in which employees are comfortable raising questions or concerns, and (d) immediately addressing and reporting, as appropriate, instances of non-compliance.
• Ethical Conduct and Compliance, Team Management, Performance Management, Individual Development Planning, Talent Management, Recruitment, People information, SHE accountabilities, and Fiscal and Financial awareness.
• Understand the legal and regulatory requirements of the role in providing appropriate resources (which could be human, financial, material, facilities, and equipment) to maintain the Quality system and continually improve its effectiveness.

Education, Qualifications, Skills and Experience

Essential

• Bachelors degree in a science / technical field such as Pharmacy, Biology, Chemistry, Engineering or Logistics/Supply Chain. A QA professional may be mentored into this role without a degree, based on experience and performance history
• Proven experience in either the pharmaceutical operations environment or pharmaceutical Quality Assurance/GMP/GDP role
• Knowledge and understanding of the principles and concepts of GxP, quality and compliance management, quality risk management and performance evaluation and control.
• Excellent oral and written communication and organizational skills
• Strong ability and motivation to learn

Desirable

• Experience working in a PCO/PET organization or Lean/Six Sigma training.
• Multi-site / multi-functional experience
• Proven experience in Quality Assurance or combination of Quality and Technical
• Experience in lead metric team and project management
• Pharmacist Degree

Why AstraZeneca?

At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and fuel your bold spirit. There’s no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and partnership, and is always committed to lifelong learning, growth, and development. We’re on an exciting journey to pioneer the future of healthcare.

What will you get?

We provide driven packages and benefits for proficient and qualified candidates; a dream team and colleagues who share ONE value, ideas, and goals.

Where can I find out more?

Visit our website www.AstraZeneca.vn

Follow us on LinkedIn www.linkedin.com/company/AstraZeneca/

Contact us via recruitment.vietnam@AstraZeneca.com