Associate Director External Quality

Typical 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 the following cGMP documentation for their Suppliers:

  • 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 Director, Supply and Quality Systems, EQ

  • Quality Investigations (Deviations, Product Quality Complaints)

  • Validation Plans, Protocols and Reports

• 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 at the Suppliers, to ensure right product at the right time is delivered into the Product Supply Chain.

• Proactively ensures GMP and regulatory compliance during the planning, execution and closeout phases of projects at their Supplier(s).

• As a member of a Supplier Management team, responsible for supporting cost saving initiatives, value creation, performance standards, continuous improvements, and issue resolutions at their Supplier(s)

• Collaborates with, and influences, other PCO/assigned area members 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 key performance indicators

• Develops and maintains effective business relationships with Suppliers

• Specific to the support and management of External Quality QMS, may be responsible for one or more of the following:

• Site Stability Management System.

• Manages quality data and records in relevant quality management support systems (e.g. Veeva Vault etc) as required.

• Assist in the production of, or contribution to, AZ quality documentation (including EQ/EQ SOPs, Q & C Manual Procedures, etc)

• Participates in EQ self-inspection program, auditing processes and procedures.

• Develops and maintains a high level of understanding of the technical production process and quality systems being utilized within the External Supply & Manufacturing (ESM) and External Quality (EQ) organisations

• Accountable for Quality decision-making; works directly with the Supplier Management leader and other team members to deliver objectives

• Ensures compliance with all GMP Compliance and Regulatory requirements by providing proper coaching, mentoring and consultation to the Supplier Management Team

• Provides functional direction as required.

• Planning for, supporting and participating in Regulatory Agency inspections of their Suppliers and AZ sites (regarding Quality management for supply of external materials to the Sites)

• As needed, perform Quality Audits within their technology area, as a Guest Auditor on the GQA lead audit team.

• Serve as EQ representative on Issue Management Teams

• Provide expert Quality input to NPI, Asset Strategy and/or Value Delivery projects. This includes identifying and assessing Suppliers, establishing Supplier’s way of working with External Quality and supporting the Supplier through to regulatory approval.

• Liaise with Suppliers to ensure successful delivery of projects

• Make decisions and advise the Supplier Management Team regarding quality and pharmaceutical technology issues within their area of expertise.

Education, Qualifications, Skills and Experience

Essential ：

• Bachelor degree in a science / technical field such as Pharmacy, Biology, Chemistry or Engineering (Note: there may be specific additional requirements depending on the regulations in each country). Proven broad experience in either the pharmaceutical operations environment or pharmaceutical Quality Assurance role

• Strong demonstrated knowledge of cGMPs, Quality Systems and the pharmaceutical supply chain environment. Also strong understanding of industry standards such as Pharmacopeia, ISO standards, etc.

• Excellent oral and written communication skills [English and local language(s)]

• Demonstrated experience working cross-functionally and managing significant improvement initiatives (e.g. project management skills)

• Strong problem solving skills

• Strong negotiating/influencing skills

• Ability to work independently under his/her own initiative.

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

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

• Masters Degree in Quality Assurance/Regulatory Affairs or other advanced scientific field

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.