Associate Director External Quality

Typical Accountabilities (per AZ framework and regulatory expectations):

• 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 proper quality oversight for warehousing activities in Astrazeneca Distribution Faclity, including but not limited to inbounding, storage, dispatch, out bouding, package Conversion.

• 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 release, 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 reposiblity to ensure the compliant quality management system set up 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.

• 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 cooperation 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

• Responsible for quality issues escalation and resolution to maintain the flow of products and documents to meet receiving site objectives.

• 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

• Accountable for QA decision-making on issues; works directly with the QA lead and other LT members to deliver objectives

• Ensures that the team complies with all GDP Compliance and Regulatory requirements by providing effective coaching, mentoring and consultation to the distribution organisation

• 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

• Bachelors degree in a science / technical field such as Pharmacy, Biology, Chemistry or Engineering. 

• 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

• Ability to travel nationally and internationally as required approximately 25% of their time. 

• GSP company working background is a must, while licensed pharmacist is preferred

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.