Production Support Manager

Production Support Manager

Requirements

• Bachelor’s degree with scientific background or equivalent and 8+ years of experience
• Master’s degree with scientific background or equivalent and 5+ years of experience
• Experience in operational roles
• Strong quality mindset
• Knowledge/understanding of supply chain logistics
• Knowledgeable in support quality investigations
• Lean/Six sigma methodology
• Experience with operational excellence and continuous improvement initiatives
• Strong communication and collaboration skills
• Good functional knowledge on industrial business processes
• Good exposure to cross site & Global Business Units networking is a plus.

Responsibilities

• Ensures on time & in full delivery of products for CMOs/External Suppliers (CMO facility is located in St. Louis, MO) within site management unit by being present at the contract manufacturing site during key manufacturing activities.
• Accountable to understand the products as it is implemented at the CMOs from an operational & financial perspective, able to provide routine technical support, and provide timely information to all stakeholders.
• Build collaborative business relationships with external partners as key partner to ensure on time & in full delivery by frequent presence at the CMO site.
• Serve as the first level of escalation to the External Manufacturing Product Teams as it relates to problems encountered with CMO activities & production.
• Actively participates in CMO driven Joint Steering Committee (JSC) meetings.
• Escalates issues to appropriate forums, as needed.
• Accountable to understand the contract guidelines and the impact to the product/departmental P&L of production variations.
• Responsible for implementing Life Cycle management projects.
• Responsible for the adherence to the Risk Management Program to identify, evaluate, document, and communicate risks potentially impacting quality and compliance; involves a multi-disciplinary team to define remediation plans to mitigate risks impacting products and GxP operations.
• Ensure Compliance through active participation at all applicable quality governance forums (including Quality Management Reviews and Periodic Business Reviews).
• Accountable for reviewing and providing technical of critical deviations.
• Accountable for on time Quality System related records, also reviews and approve all Category 3 Change Requests.
• Interface with external regulatory authorities as required.
• Works with EST, EMPT leads and Functional heads for standardization of processes and procedures required to manage CMOs and related work within External Site Team.

Preferred Qualifications

• Basic understanding of data management and digital products
• Knowledgeable in E2E product & industrial strategy, performance management, project management
• Knowledgeable in biotech/pharmaceutical industry technologies
• Deep understanding of risk identification and management
• Strong analytical skills.
• Good command of KPI target setting & monitoring