Senior Associate, Supplier Quality

Tonix Pharmaceuticals•Berkeley Heights, NJ

20h•$80,000 - $110,000

About The Position

The Senior Associate, Supplier Quality performs activities for the Quality Assurance Supplier Quality function. The individual in this position performs duties associated with the implementation and maintenance of Quality procedures, standards and systems related to GxP activities. The individual in this position executes aspects of the supplier quality management program that provides materials and services to Tonix for GxP operations as well as external contract organization activities. The individual in this position works with the other Quality functions to ensure patient safety and compliance with FDA and other applicable global health authority requirements. The individual in this position also is directly involved in the execution of QA strategic planning for continuous improvement and reporting/escalation of quality issues and/or risk mitigation activities pertaining to GxP activities and to ensure a culture of quality and compliance.

Requirements

Demonstrated troubleshooting and problem-solving skills
Ability to analyze a wide variety of information and data to support decisions regarding potential risks associated with regulatory compliance
Knowledge of global pharmaceutical industry regulations, standards, and guidelines, such as, cGMPs (FDA, EMA), USP and other Pharmacopeia, FDA Guidance, 483s, Warning Letters, EIRs etc.
Collaborative, results-driven team player who excels in a dynamic environment
Dedicated team player who can withstand the high demands of a fast-paced environment
Strong planning and organizational skills
Comfortable working independently with minimal supervision
Highly organized, results driven, problem solver, and collaborator
Excellent organizational, written, and verbal communication skills
Demonstrated ability to perform the essential duties of the position with or without accommodation
Ability to travel up to 10%
Bachelor’s degree in science or other related discipline or equivalent work experience required
Five (5) plus years of Supplier Quality related experience in the biotechnology/pharmaceutical industries required

Nice To Haves

GxP auditing and inspection experience preferred

Responsibilities

Execute day-to-day operations of supplier quality assurance
Maintain the Approved Supplier List and supplier management files including audit documentation
Execute GxP contractor and consultant qualification process
Manage supplier quality agreement review and approval
Maintain the Supplier Change Notification and Supplier Corrective Action Reporting processes to ensure supplier adherence to Tonix requirements
Provide compliance input for internal teams as well as external contract organizations related to supplier quality
Collect and monitor metrics to ensure control of systems and drive continuous improvements
Maintain and support the internal audit program as well as participate in regulatory inspections
Develop and implement GxP quality standards, policies, and procedures
Execute supplier audits with the supplier quality team, as needed.
Follow all established occupational health and safety procedures, good manufacturing practices (GMP’s) and standard operating procedures (SOP’s)
Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
Perform ad-hoc work/special projects as necessary to support Tonix on various business initiatives