Associate Director, External Quality

Introduction to role

Are you ready to take on a pivotal role in ensuring the highest standards of quality for life-changing medicines? As the Associate Director, External Quality, you will be responsible for leading the Quality of assigned External Suppliers within various categories including API, DS, Cell Bank, Formulation & Packing (F&P), Vaccine, and Critical Material Supplier (CMS). Your role will encompass a wide range of Quality activities, from leading all aspects of Quality Systems to running product releases and regulatory interactions. You will work cross-functionally with various teams to ensure that our suppliers meet the quality standards required to deliver safe and effective products to patients. (locations include: Gaithersburg, MD, Coppell, TX, Wilmington, DE, Mt. Vernon, IN)

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 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.

• Resolve quality issues related to customer concerns at Suppliers for timely product deliveries.

• 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.
• Handles quality data and records in relevant quality management support systems (e.g. Veeva Vault etc) as the need arises.
• 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 the need arises.

• 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 experienced 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.

Essential Skills/Experienc