5004 Manager, Critical Reagent and Reference Standard Inventory Management
DUTIES:
This is a temporary manager level position in the Quality Science and Technology (QSAT) for the centralized program management of reference standards and critical reagents used in the testing of clinical and commercial products.
The core function of this role is to establish an integrated inventory management process for reference standard and critical reagents.
The integrated inventory management process would incorporate a system for determining material consumption rates, reporting material inventory levels and planning lead times for their preparation, qualification, and release.
The manager will own and improve the integrated inventory management process, including transformation of the process from a manual system to electronic system.
The individual is expected to perform routine job functions independently with minimal supervision. The manager is expected to build effective relationships/partnerships and communicate well with its partners, including Quality Control (internal and external), Quality Assurance, Product Quality Leaders, Technical Development and Regulatory Affairs.
RESPONSIBILITIES
Detailed responsibilities include but are not limited to the following:
Develops and owns the integrated inventory management process.
Assess the current reference standard and critical reagent inventory management process and practices in internal and external Quality Control Laboratories.
Build an effective partnership and collaborate with Quality Control (internal and external), Quality Assurance and Technical Development to develop and implement an integrated inventory management and documentation system for reagent certification with clear roles and responsibilities.
Establish lead times required for timely critical reagent and reference standard preparation, qualification and release for use.
Identify the minimal inventory level that triggers the process for qualifying and obtaining regulatory approval if needed.
Establish an effective partnership with Regulatory Affairs to understand the regulatory requirements for submission and lead time for approvals in the various countries.
Lead transformation of the current processes to an electronic solution for efficient, sustainable, planned & predictable performance.
Proactively measures and improves process health.
Establish and provide routine status reports on the inventory levels to quality management.
Escalate if the inventory is at a critical level to Quality Assurance Management, Quality Control (internal and external) and Product Quality Leaders.
Ensure all individual training and guidelines are kept current.
Manage and complete assigned projects, as needed.
Assist with regulatory and internal inspections, as needed.
SKILLS:
Collaborative Leadership – Ability to influence with or without authority, facilitate groups with diverse perspectives, bring teams to consensus/alignment. High tolerance for ambiguity and able to create order from chaos. Builds credibility through solid relationships and solid track record of results.
Ownership and Accountability – Takes accountability for actions, drives results, and able to learn from mistakes. Delivers on promises, goals, and expectations. Makes quality decisions and resolves problems with minimal delay as appropriate.
Communication – Ability to communicate effectively up and down, at all levels of the organization, present complex and/or new ideas with clarity and simplicity. Ability to draft and deliver clear and concise procedures or business process documents.
Planning – Excellent planning and prioritization skills with the ability to multitask and adapt. Able to synthesize large amounts of information. Able to deliver results despite shifting environment.
Analytical Problem Solving – Ability to identify problems, define problem statement clearly and accurately and apply structured and disciplined methodology to identify data-driven root causes. Innovative and effective in solution development, risk mitigation, and execution.
Customer focus – Partners with customers, looks ahead to predict future customer needs. Manages expectations.
REQUIRED SKILLS:
Minimum 6 years of experience in a Quality/Compliance/Regulatory setting Sound knowledge of cGMPs and equivalent industry regulations.
Prior experience with technical oversight of Deviations and CAPAs.
Proficiency with computer systems, Microsoft Office Suite.
Proficiency with TrackWise or QMS, LIMS, Oracle, EDMS, and Office365 preferred.
EDUCATION:
BS in a technical science field.
PLEASE NOTE: Our client has mandated COVID-19 vaccination for their workforce, all external personnel providing services to our client are required to comply with this requirement.