Supply Chain & Warehouse QA Senior Manager

Supply Chain Management (SCM) and Warehouse (WH) QA Senior Manager

The Supply Chain Management (SCM) and Warehouse (WH) QA Senior Manager will play a key role in supporting supply chain and warehouse functions to ensure the highest standards of professional excellence and quality assurance in the business with responsibility for supporting the Pharmaceutical Quality System (PQS) in place adhering to all regulatory cGMP and company requirements and ensuring all necessary plans and standards are achieved by consistently maintaining a high level of quality via directly supporting and as a leader for SCM and WH QA Team. This role is critical in releasing materials key consumables and DS batch release via the review and approval of dispensing records.

Organization Description

WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. We enable our clients to research develop and manufacture drugs from the concept phase to commercial manufacturing. Our mission is to accelerate and transform discovery development and manufacturing in the rapidly growing field of biologics to benefit patients worldwide. We have sites/offices in China the US the EU and Asia. We currently employ over 10000 people and provide services to more than 200 customers worldwide.

Department Description

As Supply Chain Management (SCM) and Warehouse (WH) QA Senior Manager youll be joining an organization where people of all backgrounds and experiences are respected and where we work together focused on changing this role you will report to the QMS Lead.

Your Responsibilities:

• Lead the SCM & WH QA team providing quality monitoring and online QA oversight to Warehouse and SCM including dispensing operations.
• Ensure that warehousing dispensing shipping and other operations as applicable are conducted according to appropriate cGMP behaviours and compliance to SOPs and other cGMP documentation as applicable.
• Supervise direct reports on a day-to-day basis provide training and communications assignments and prioritization of work.
• Ensure compliant release of GMP materials and key consumables.
• Ensure proper review and execution of dispensing records as prerequisite for DS batches certification by the qualified person (QP).
• Manage abnormal materials process and disposition.
• Review and decision making for receiving inquiries raised by WH team.
• Approval of materials and DS shipments ensuring correct status and conditions for shipments.
• Management of all rejected and quarantined materials.
• Leading quality monitoring and oversight program for SCM and WH teams.
• Oversee dispensing cleanroom status and recovery process.
• Responsible for electronic data review where related to DS baches storage and release.
• Manage performance delivery of objectives and career development of direct reports.
• Provide QA review and approval of SOPs quality risk assessments change controls and other documentation as applicable associated with Warehouse and SCM.
• Liaise with Warehouse SCM and QC teams as appropriate to ensure that all deviations investigations and dispensing review comments are adequately addressed and closed out in a timely manner as defined in SOPs.
• Work with Warehouse SCM and QC teams as appropriate to ensure that all CAPAs change controls self-inspection observations etc. relating to warehousing and SCM are addressed and closed out in the required time frame.
• Liaise with Warehouse SCM Manufacturing QA QC supporting daily operations.
• Ensure clear communication on issues and timely escalation as applicable.
• Identify and drive opportunities for continuous improvement.
• Coordinate with internal Quality peers to ensure on-time disposition of drug substance materials.
• Provide support and expertise for the preparation of regulatory submissions inspection readiness activities during health authority inspections including interaction with inspectors responses to inspection observations and monitoring of follow up actions.
• Collaborate internally and also across the WuXi network to achieve quality goals.
• Lead and/or represent QA on multidisciplinary teams as required.
• Perform all duties in accordance with GMP requirements SOPs and controlled documents.
• Deputize QMS Lead whenever delegated.
• Will be flexible to take on additional tasks and responsibilities at the discretion of the QMS Lead.
• Will act as a role model for the Quality Assurance function and also the wider organisation in adherence to the WuXi corporate core values and PROUD culture.

Your Profile: The ideal candidate for this position will have the following:

Education:

• Preferable that the individual has qualification Degree in Biopharmaceutical/ Pharmaceutical Science or other related science discipline.

Knowledge/Experience

Required:

• More than 8 years experience in the biotechnology and/or pharmaceutical industries within a Quality role preferably in QA or QC or Warehouse & Distribution (GDP) or Manufacturing Operations within the biopharmaceutical/ pharmaceutical industry.
• Experience of leading teams would be an advantage.
• Experience working on QA/QC incoming material inspection or warehouse operations would be advantage.
• Experience working with SAP would be an advantage.
• Experience in performing internal audits would be an advantage.
• Demonstrated knowledge of Quality Management System and continuous/process improvement tools.
• Demonstrated knowledge of good storage and distribution practices.
• Demonstrated knowledge of risk management and materials qualification.

Personal skills

Preferred:

• Proven decision-making capabilities.
• Demonstrated collaboration negotiation conflict resolution skills and inclusive approach with a teamwork mindset.
• Analytical problem solving & root-cause analysis skills
• Able to challenge the status quo with a continuous improvement mindset.
• Excellent interpersonal verbal and written communication skills
• Self-starter and self-motivated; organized with good attention to details.
• Comfortable working in a fast-paced environment and able to adjust workloads based on changing priorities
• Results oriented with the ability to manage multiple priorities in a short period of time.
• Demonstrate strong ethics in adhering to company procedures and policies regulatory standards and our customers expectations.

As we extend our global reach we need colleagues interested in change in challenge and in building a new future together. Reach beyond yourself and discover your true potential! Apply now!

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