Quality Systems Manager

1 month ago

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

Sampled is seeking an accomplished Quality Systems Manager to join our team based at our Headquarters in Piscataway, New Jersey. As a key member of our Quality Assurance team, you will be responsible for ensuring the implementation and maintenance of our Quality Management System (QMS) in accordance with regulatory guidelines and industry standards.

Key Responsibilities
  • Manage QMS processes, including Nonconformance/Quality Events, CAPAs, and Complaints.
  • Review and approve procedures in support of our QMS.
  • Continually assess eQMS processes for potential gaps and ensure compliance with regulatory guidelines and industry standards.
  • Manage the eQMS, including workflow configuration and upgrades as needed, and collaborate cross-functionally to identify, define, and implement process improvement opportunities for enhanced workflows.
  • Provide guidance and training on quality events, including investigations, CAPAs, audit observations, and drive the timely completion of records.
  • Support the creation and presentation of applicable QMS training materials to ensure ongoing education on core quality procedures and applicable industry standards.
  • Establish, compile, track, and present Quality Metrics to support Quality Management Review.
  • Participate in regulatory inspections and/or internal audits, representing our Quality System.
  • Ensure that QEs/CAPAs resulting from audits associated with assigned programs and studies are allocated an owner and closed out appropriately and timely.
  • Write, review, or approve Standard Operating Procedures and internal investigations, as applicable.
  • Proactively influence management regarding the implementation and/or adoption of standards to improve quality, efficiency, and compliance.
  • Strong leadership, communication, and cross-functional collaboration skills.
  • Support internal and external inspections/audits as backroom Lead, encompassing identification, reporting, and supporting process issues, working to offer solutions.
  • Collaborate and communicate across operational areas of the business to ensure standardization of quality culture.
  • Identify areas for continuous improvement in all areas of the business.
  • Able to train and mentor other members of the Quality Assurance Team.
  • Able to deputize for the Sr. Manager, Quality Assurance as required.
Requirements
  • Ideal candidate has a Bachelor's degree in Science or Engineering.
  • Relevant industry experience, ideally in Biotechnology, Pharmaceutical, or Medical Device industry.
  • Extensive experience in Quality Assurance or similar regulatory field.
  • Extensive working knowledge of relevant regulations and standards; GLP, GCP, CLIA, ISO13485, ISO9001.
  • Strong understanding of Quality Management System principles and their application to drive continuous improvement.
  • Excellent root cause analysis/CAPA, problem-solving, and analytical skills.
  • Good communication skills, both verbal and written. Able to communicate effectively with clients, regulators, visitors, suppliers, and colleagues.
  • Able to effectively lead and manage change and create buy-in to a Quality-driven culture throughout the organization.
  • Good interpersonal skills, Acts professionally at all times. Easily builds rapport with others. Collaborative team member with those in Quality Assurance and all internal departments.
What We Offer

Sampled is committed to building a sustainable, inclusive, and diverse culture where team members enjoy equal opportunities in a safe, supportive, and empowering environment.

Sampled believes that as an organization, we have a duty to be actively engaged in supporting not just the clients and industries we serve but the communities where we live and work.

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