Associate Director, Laboratory Quality Assurance

Job Description

The Associate Director of Laboratory Quality Assurance within the Quality Assurance Center of Excellence is responsible for providing Quality direction and oversight to West Point (WP) Laboratory Operations in the management of those areas assigned, such as Internal Auditing, Training, Change Control, Inspection Management, Deviation Management and Risk Management, in order to maintain compliance with Regulatory requirements.  The individual is an Advocate for the development, execution and deployment of WP Site and our Company Manufacturing Division priorities.  The Associate Director drives quality improvement activities and ensures alignment across Laboratory Operations in the execution of their assigned areas. The individual is responsible for the development and maintenance of Quality Systems in Laboratory Operations in accordance with current Good Manufacturing Practices (cGMPs), Good Laboratory Practice (GLPs), international regulations and our Company guidelines, policies and procedures. 

The Associate Director will lead key compliance projects for Laboratory Operations aimed at elevating the compliance posture.  As a Project Manager, the individual is expected to fully manage all aspects of assigned projects, including but not limited to:  quality decision making, stakeholder management, issue identification and resolution, and driving all aspects of the project in alignment with established timelines.

Primary Responsibilities

• Maintains strong quality management systems to actively ensure compliance while striving to optimize Quality Operations within the Laboratory.

• Actively participates in the Tier process, as appropriate, and uses this forum to escalate concerns and best practices.

• Serves as an Ad Hoc member of WP Site Quality Council.

• Responsible for the Quality oversight and classification / approval of investigative events in Laboratory Operations by: 1) Providing guidance to Senior Quality Specialists performing reviews/approvals of investigative events; and 2) Determining the effects on test result validity, for laboratory investigative events, to ensure final reportable values are representative of the product’s quality.

• Provides input on recommended Corrective Action and Preventive Action (CAPAs), as appropriate

• investigative Quality Notification (iQN) approvals & assessment

• Performs review and approval for CAPAs, Quality Compliance Tracking System (QCTS) commitments, change requests, investigative protocols and final reports.

• Performs review and approval of Installation Qualification/Operation Qualification/Process Qualification (IQ/OQ/PQ) documents for assigned laboratories of responsibility, as needed.

• Reviews and approves Standard Operating Procedures (SOP), Controlled Job Aides (CJA), Control Procedures, Quality Standards, etc.

• Provides coaching and guidance to new personnel and to Quality Specialists and Sr. Quality Specialist colleagues.

• Provides support to Regulatory Agency inspections as needed.

• Proactively partners with Laboratory Operations and Laboratory Technology personnel to ensure that all process improvements and capital projects are timely, robust and in alignment with corporate goals.

Education Minimum Requirements

• At least a Bachelor's degree in life science, scientific discipline or engineering area of study.

Required Experience and Skills

• For candidates with a Bachelor’s degree, a minimum of five years of experience in GMP Manufacturing environment, Pharmaceutical/Biological Quality, Operational, Technical or Regulatory function supporting manufacturing or testing operations, or related industry experience in a laboratory, manufacturing, science related or regulated setting.

• For candidates with a Master’s degree, a minimum of three years of experience in GMP Manufacturing environment, Pharmaceutical/Biological Quality, Operational, Technical or Regulatory function supporting manufacturing or testing operations, or related industry experience in a laboratory, manufacturing, science related or regulated setting.

Preferred Experience and Skills

• Progressive and demonstrated Quality decision making responsibility

• Project Management, Change Execution Management and Team Leadership experience in a Quality function.

• Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work in a team environment.

• Demonstrated self-starter with capability to d