Supplier Quality Manager
2 weeks ago
Key Accountabilities
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. 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. 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 RequestsProduct Quality Reviews (API and F&P PCOs only) or Supplier Quality Review (DMS)CMC documentation (ANGEL) associated with changes or product establishment at Suppliers (API and F&P PCOs only)Development and technology transfer documentation (API and F&P PCOs only), along with Director, Supply and Quality Systems, External Sourcing &Logistic QualityQuality Investigations (Deviations, Product Quality Complaints and S&L 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 Sourcing & Logistics 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 ( EQV, GCM, OCM, LIMS, ANGEL etc) as required. Assist in the production of, or contribution to, AZ quality documentation (including EQ SOPs, Q & C Manual Procedures, etc) Participates in EQ self-inspection program, auditing processes and and quality approval of Direct Material Specifications issued by PT&D/PharmSci. (EMEA DMS Team)In addition to the above Key Accountabilities a Quality Supplier Manager is expected include in their remit the following :
Serve as External Quality 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 Suppliers way of working with External Quality and supporting the Supplier through to regulatory approval. Develops and maintains a high level of understanding of the technical production process and quality systems being utilized within the PCO Supplier Management teamAccountable for Quality decision-making; works directly with the Supplier Management leader and other team members to deliver objectivesEnsures compliance with all GMP Compliance and Regulatory requirements by providing proper coaching, mentoring and consultation to the Supplier Management TeamProvides functional direction as required. Product Release - Assigns Usage Decision for Formulated and Packaged products (in accordance with Manufacturing License), Active Pharmaceutical Ingredients, Starting Materials, Medical Devices, includingBatch record reviews (including certificates of analysis/conformance, assessment of deviations as required) including working in relevant quality management systems (SAP, GQCLIMS).Assign Usage Decision for batches affected by Critical deviations, assessed by Senior Quality Supplier Manager or Qualified PersonsIssuance of certificates within GQCLIMS system and manually.Education, Qualifications, Skills and Experience
Essential
Bachelor degree in a science / technical field such as Pharmacy, Biology, Chemistry or Engineering. 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 Mandarin] Demonstrated experience working cross-functionally and managing significant improvement initiatives ( 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 approximately 10% 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 fieldDate Posted
13-6月-2024Closing Date
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