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Quality Assurance Systems Lead

2 months ago

Piscataway, New Jersey, United States Sampled Full time
Job Overview

COMPANY BACKGROUND: Sampled is at the forefront of enhancing human health by utilizing active biological samples through preservation, immortalization, and application in extensive multiomics research within a premier Global Integrated Analytical Biorepository. We are in search of a skilled Quality Systems Manager with a robust background in Biotechnology, Pharmaceuticals, or Medical Devices to contribute to our mission.


POSITION SUMMARY: The Quality Systems Manager serves as a key technical expert in the principles and implementation of quality systems and regulatory compliance. This role is responsible for aligning and executing procedures and processes related to the Quality Management System (QMS) while driving quality enhancements across the organization. The individual will oversee projects and engage in the design and execution of processes, ensuring the establishment, maintenance, and improvement of Quality Systems throughout the company.


KEY RESPONSIBILITIES:

  • Oversee QMS processes including Nonconformance/Quality Events, CAPAs, and Complaints.
  • Review and endorse procedures that support Sampled's QMS.
  • Continuously evaluate eQMS processes for compliance with regulatory standards and identify potential gaps.
  • Manage the eQMS, including workflow configuration and necessary upgrades, while collaborating across departments to implement process improvements.
  • Act as a Subject Matter Expert (SME) for the QMS, providing guidance and training on quality events, including investigations, CAPAs, and audit findings.
  • Assist in the development and delivery of QMS training materials to ensure ongoing education on core quality procedures and industry standards.
  • Establish, compile, track, and present Quality Metrics to support Quality Management Reviews.
  • Participate in regulatory inspections and internal audits as a representative of the Quality System.
  • Ensure timely allocation and closure of QEs/CAPAs resulting from audits related to assigned programs and studies.
  • Draft, review, or approve Standard Operating Procedures and internal investigations as necessary.
  • Influence management proactively regarding the adoption of standards to enhance quality, efficiency, and compliance.
  • Exhibit strong leadership, communication, and collaborative skills across functions.
  • Support internal and external inspections/audits as the backroom Lead, identifying and addressing process issues while proposing solutions.
  • Facilitate communication across operational areas to ensure a unified quality culture.
  • Identify opportunities for continuous improvement across all business areas.
  • Mentor and train other members of the Quality Assurance Team.
  • Serve as a deputy for the Senior Manager, Quality Assurance when necessary.
  • Champion the values of Sampled.

POSITION REQUIREMENTS:

  • Bachelor's degree in Science or Engineering is preferred.
  • Relevant experience in the Biotechnology, Pharmaceutical, or Medical Device sectors.
  • Extensive experience in Quality Assurance or a similar regulatory field.
  • In-depth knowledge of applicable regulations and standards, including GLP, GCP, CLIA, ISO13485, and ISO9001.
  • Strong grasp of Quality Management System principles and their application for continuous improvement.
  • Excellent skills in root cause analysis, CAPA, problem-solving, and analytical thinking.
  • Effective verbal and written communication skills, capable of engaging with clients, regulators, and colleagues.
  • Able to lead and manage change while fostering a quality-driven culture within the organization.
  • Strong interpersonal skills, demonstrating professionalism and the ability to build rapport.

RESULTS-ORIENTED: The ideal candidate will demonstrate a commitment to achieving optimal results, be a self-starter, and work effectively with minimal supervision.

  • Exceptional analytical, problem-solving, and decision-making abilities.
  • High attention to detail and accuracy.
  • Strong planning, prioritization, project management, and organizational skills.
  • A desire for personal and professional growth within the organization.

Sampled is dedicated to fostering a sustainable, inclusive, and diverse culture where all team members have equal opportunities in a supportive and empowering environment.

As an organization, Sampled is committed to actively engaging with the communities we serve and supporting the industries we operate within.