Quality Assurance Systems Leader

1 week ago

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

COMPANY INSIGHT: Sampled is at the forefront of enhancing human health by utilizing biological samples for advanced multiomics research within a state-of-the-art Global Integrated Analytical Biorepository. We are in search of a skilled Quality Systems Manager with a background in Biotechnology, Pharmaceuticals, or Medical Devices to contribute to our mission.


POSITION SUMMARY: The Quality Systems Manager serves as a key technical authority on quality systems and compliance. This role is responsible for coordinating and executing the alignment of procedures and processes related to the Quality Management System (QMS) while driving continuous quality enhancements. The incumbent will oversee projects and participate in the design and execution of processes, ensuring the design, implementation, maintenance, and enhancement of Quality Systems across the organization.


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 configurations and necessary upgrades, while collaborating across departments to identify and implement process improvements.
  • Act as a Subject Matter Expert (SME) for the QMS, providing guidance and training on quality events such as investigations, CAPAs, and audit findings.
  • Assist in the development and presentation 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, representing the Quality System.
  • Ensure timely allocation and closure of QEs/CAPAs arising 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 a backroom Lead, identifying and addressing process issues while proposing solutions.
  • Foster collaboration across operational areas to promote a unified quality culture.
  • Identify opportunities for continuous improvement throughout the organization.
  • Train and mentor members of the Quality Assurance Team.
  • Serve as a deputy for the Senior Manager, Quality Assurance when required.
  • Champion quality initiatives.

POSITION REQUIREMENTS:

  • Bachelor's degree in Science or Engineering is preferred.
  • Relevant experience in the Biotechnology, Pharmaceutical, or Medical Device sectors.
  • Extensive background in Quality Assurance or a similar regulatory field.
  • In-depth knowledge of relevant 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, maintaining professionalism and building rapport with others.

RESULTS ORIENTED: Demonstrates a commitment to achieving optimal results, is a self-starter, and can work independently.

  • Exceptional analytical, problem-solving, and decision-making abilities.
  • High attention to detail and accuracy.
  • Strong organizational, planning, and project management skills.
  • A desire for continuous learning 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. We believe in actively engaging with the communities we serve and operate in.

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