SGS North America
Quality Assurance Manager
At a glance
Location: US-NJ-Fairfield Map
Posted: 09/30/2019
Closing: 10/29/2019
Degree: Not Specified
Type: Full-Time
Experience: Not Specified
SGS North America
Job description
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 90,000 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.

Trusted all over the world, SGS is a market leader because we put 100% passion, pride and innovation into everything we do. We encourage new ideas. We welcome people who challenge the way we do things. And we will be 100% committed to helping you reach your full potential.

Life Sciences Services (LSS) from SGS – optimize your development timelines to get medicines and medical devices to market quickly and safely. As a result, we are often a preferred partner for the top 20 pharmaceutical and biotechnology companies.

Job Summary:The duties of the Quality Assurance Team Manager are twofold. One is to perform the functions defined by Good Manufacturing Practices (GMP) and Good Laboratory Practice (GLP) regulations.
The other is to help oversee the management of all quality systems at the laboratory and communicate the status of those systems to the Director and executive management. This is accomplished primarily through management and auditing functions.
Specific tasks may be delegated to additional staff with the understanding that the QA Assistant Manager and Director retain oversight authority and responsibility in these areas. Overall, the QA Assistant Manager’s role is crucial to the success of the laboratory, and presents the employee with a unique and rewarding set of challenges.

Service Responsibilities to internal & external stakeholders
  • Act as a liaison to client auditors and regulatory inspectors. Host and coordinate inspections involving the company officer and department heads as necessary with regulatory agents on site.
  • Prepare responses to audit reports from clients and regulatory agencies.
  • Administer system(s) for handling client problems or complaints.
  • Act as a regulatory resource for SGS clients. Ensure that all client request for information pertaining to current regulations are met promptly and effectively.
  • Provide laboratory staff and management with current regulations and industry compliance news by attending industry meetings and workshops and by acquiring and evaluating current guidelines.
  • Together with other department managers and directors, plan for cross-departmental workshop training as needed. Plan and hold group one-on-one continued training on issues pertaining to regulatory compliance.
  • Involve staff in audit follow-up procedures for the purpose of instruction, feedback, and continuing staff development.

Administrative Responsibilities
  • Compliance-driven projects. Quality improvements to increase the laboratories’ level of compliance (e.g. process validation, documentation systems).
  • Competitive advantage projects. Quality improvements to increase laboratory efficiency of decrease quality costs thereby providing the company with a competitive advantage.
  • Measurement and feedback projects. Projects designed to measure specific quality parameters and provide organized, evaluated information to corporate officers and department heads. These include programs that measure report error rates, turnaround time, customer satisfaction, etc.
  • Approve and Issue Certificate of Analysis.

Core GLP, GMP/ISO Responsibilities:
  • Perform in-life audits of GLP studies.
  • Perform final audits of GLP reports.
  • Assist in the maintenance of the Master Schedule and archives.
  • Assist in coordinating and conducting regular management Review Meetings.
  • Perform internal audits of departments, data, systems, and facilities. Report findings to management. Organize and plan follow-up inspections as part of corrective action processes.
  • Perform audits of vendors and subcontractors as mandated by management.
  • Write SOPs pertaining directly to quality functions.
  • Oversee archiving of non-GLP documentation per internal retention requirements.
  • Provide new employees with appropriate training documents.
  • Provide all employees with training in GMP, GLP, ISO, and other applicable regulations as well as the role of quality assurance in the laboratory.
  • Review new or revised SOPs generated at the facility (as assigned).
Job requirements

Education, Required Skills & Competencies:
  • B.S. or M.S. required.
  • Thorough knowledge and understanding of GMP/GLP regulations required.
  • Thorough knowledge and understanding of ISO standards required.
  • Minimum five years experience in a GMP/GLP laboratory setting required.
  • Auditor certification preferred.
  • Knowledge of and familiarity with word processing and database software required.
  • Solid leadership skills essential. Must be able to lead both by example and through direct authority. Must be able to unite staff under common goals pertaining to quality. Must be able to build consensus across departments. Must be able to deliver criticism in a constructive, diplomatic manner.
  • Must be capable of working at a desk and computer terminal for up to three hours at a time, and for up to eight hours on a given day.
  • Must be capable of sustained concentration over printed materials for several hours at a time.
  • Must be able to obtain and assess objective evidence fairly.

Additional Information:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skill, and/or ability required. This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company’s rights to assign or reassign duties and responsibilities to this job at any time. 

SGS is an EOE AA M/F/Vet/Disability employer. 

Qualified applicants will receive consideration for employment without regard to their race, color, religion, national origin, sex, protected veteran status or disability. 

If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call 201-508-3149 for assistance and leave a message. You will be called back shortly. Please note, this phone number is not for general employment information, but is only for individuals who are experiencing difficulty applying for a position due to a disability.
Quality Assurance Manager