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.
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/Experience
• Bachelor’s 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).
• Minimum of 8 years of relevant experience (experience in Quality Assurance or combination of Quality and Technical)
• Shown broad experience in either the pharmaceutical operations environment or pharmaceutical Quality Assurance role
• Strong proven 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)]
• Proven experience working cross functionally and leading significant improvement initiatives (e.g. project management skills)
• Strong problem-solving skills
• Strong negotiating/influencing skills
• Ability to work independently under their own initiative.
• Ability to travel nationally and internationally as the need arises up to 25% of their time.
Desirable Skills/Experience
• Experience working in a PCO/PET organization or Lean/Six Sigma training.
• Multi-site / multi-functional experience
• Shown experience in Quality Assurance or combination of Quality and Technical
• Master’s degree in Quality Assurance/Regulatory Affairs or other advanced scientific field
Ready to make a difference? Apply now!
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