SGS is the global leader and innovator in inspection, verification, testing and certification services. Founded in 1878, SGS is recognized as the global benchmark in quality and integrity. With over 97,000 employees in 130 countries and operating a network of more than 2,400 offices and laboratories, we provide services to almost every industry by assuring quality and safety of products and services.
Job Description
The QA Manager performs audits of internal processes according to ISO 19011 standards, support in regulatory audits, and remains knowledgeable of regulatory requirements and accreditation standards, including, but not limited to Good Clinical Practices, International Center for Harmonisation, Food and Drug Administrations, ISO 17025, ISO 22716, and ISO 19011. May participate in developing policies, procedures and methods to evaluate and improve the quality of products, materials, components and/or operations. Will oversee the regulatory process of clinical monitoring for studies performed at the SGS Cosmetic and Hygiene sites in North America.
Reviews regulatory requirements and various audit scopes to ensure compliance with the requirements of (requirements for a quality management system where an organization needs to demonstrate its ability to perform clinical trial studies on human subjects according to all guidelines and standards to ensure that deliverables consistently meet customer and applicable regulatory requirements)
Upon receiving evidence gained during audits performed by Auditors, makes a determination whether or not registration should be recommended or allowed to continue.
Assimilate, understands and operates the SGS Cosmetics and Hygiene Quality Manual and all activities relevant to the manual, and to liaises with the Operational leaders regarding changes to its design and implementation.
Actively participates in witness auditing and clinical monitoring procedures by SGS, sponsors, or accreditation bodies.
Undertakes any other activities as directed by the Senior Leadership Team.
Adheres to internal standards, policies and procedures.
Performs other duties as assigned.
Qualifications
Bachelor's degree in one or more of the following areas: Biology or Microbiology, Chemistry or Biochemistry, Business Administration, Quality Assurance, Regulatory Compliance, etc - Required
3+ years of experience as a Quality Assurance Professional and 2+ years of experience in a Quality Assurance or Operational Leadership role. - Required
Working knowledge of GCP and ICH E6 standards. - Required
1+ year of experience as a Lead Auditor, or 3+ years as support on an auditing team - Required
1+ year of experience in clinical monitoring - Preferred
