Quality Account Manager

Modis Life Science is now looking for a Quality Account Manger for a consultancy position at AstraZeneca in Södertälje. As a consultant you will be hired by Modis. Send your application ASAP no later than Janyary 10th.

About the assignment:

As a Quality Account Manager you will be responsible for the Quality management of assigned Supply Chains, supporting the External Supply organization. You will be responsible for all Quality activities that directly support the establishment and execution of Quality Management of Product Supply Chains covering end to end supply of the externally sourced products. You will operate as the primary interface between Quality and the Supply Chain Leads, and as the Quality leader role in the escalation of quality supply chain issues.
As required, you will serve as a Quality leader in the review of new Product Supply Chains, including preparation for, and management of Regulatory Agency inspections for QA/Compliance assessments of Product Supply Chains.
Participating in Supply Chain Control room meetings, you will actively perform activities such as CI/PPS, IRM, supply chain map reviews, Supply Chain Quality Master data design/set-up, coaching and seeking to make Supply processes efficient. You will report Quality SC critical metrics on a routine basis and perform first assessment on rework and SAOC/PAOC proposals.
The role holder is responsible for Area Manager approval of Change Controls, or Management of own change controls.
The Quality Account Manager is the point of contact for the Senior Quality Supplier Managers (SQSMs) on their Product Supply Chain, when quality issues at a supplier level impact delivery.
This position enables strong cross-functional ways of working with non-QA members across the External supply organisation, AZ Sites and GSC&S.

Key Accountabilities
• Collaborates with and influences other Quality professionals across the organization to ensure consistent application and execution of key quality systems
• Responsible for the Supply Chain Quality Master data in the SAP systems
• Responsible for quality issues escalation and resolution to maintain the flow of products and documents to meet Customer, receiving Site objectives
• Works with applicable Site support groups on projects (capital and non-capital) that impact the PCO assigned area, and proactively ensures GMP and regulatory compliance during the planning, execution and closeout phases of these projects
• 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
• Collaborates in data analysis and report creation on quality metrics and key performance indicators
• Builds effective business relationships with Customers and AZ receiving sites
• Assists in the production of, or contribution to, AZ quality documentation (including SOPs, Q & C Manual Procedures, etc)
• Actively participates in CI/PPS activities in Supply Chains and QMS
• Develops and maintains a high level of understanding of the technical production process and quality systems being utilized within the PCO Management team
• Accountable for Quality decision-making; works directly with the Supply Chain Management leader and other team members to deliver objectives
• Ensures compliance with all GMP Compliance and Regulatory requirements by providing coaching, mentoring and consultation to the Supply Chain Management Team and Sr. QSMs involved in Supplier management
• Provides functional direction when required

Essential Requirements:
• Bachelor degree in a science / technical field such as Pharmacy, Biology, Chemistry or Engineering, or equivalent experience
• Strong demonstrated knowledge of cGMPs, Quality Systems and the pharmaceutical supply chain environment
• Excellent oral and written communication skills
• Strong negotiating/influencing skills
• Ability to work independently and under own initiative

Desirable Requirements:
• Experience working in a PCO organization
• Demonstrated leadership capability and organizational skills to act as the Quality leader for Product Supply Chain(s)