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Form of workSGS is the world's leading inspection, verification, testing, and certification company. We are recognized as the global benchmark for quality and integrity. With more than 89,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.
The Manager, Quality Assurance will oversee the management of all quality systems at the laboratory and communicate the status of those systems to executive management. This is accomplished primarily through training and auditing functions. The Manager, Quality Assurance will perform the functions defined by Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) regulations.
- Manages Quality Assurance Team and Quality Assurance systems functions at the site level
- Has full responsibility for employees' actions (hires, fires, trains and coaches staff, conducts annual performance evaluations, makes recommendations for salary changes)
- Structures and organizes the Quality Assurance department staff to ensure quality functions are being performed as required
- Manages staff in audit follow-up procedures for the purpose of instruction, feedback, and continuing staff development
- Participates in Strategic Planning for the department
- Oversees the management of all quality systems at the laboratory
- Acts as liaison to customer auditors and regulatory inspectors.
- Hosts and coordinates inspections involving the company as necessary with regulatory agents on-site
- Acts as a regulatory resource, support, and coordinator for SGS customers and staff
- Prepares responses to audit reports from clients and regulatory agencies
- As a part of the leadership team, conducts cross-departmental workshop training
- Performs in-life audits of Good Laboratory Practice (GLP) studies
- Performs final audits of Good Laboratory Practice (GLP) reports
- Acts as the site Management Representative
- Performs internal audits of departments, data, systems, and facilities. Reports findings to management. Organizes and plans follow-up inspections as part of corrective action processes
- Performs audits of vendors and subcontractors as mandated by executive management
- Oversee maintenance of SGS Operations Manual. Maintains file of all historical procedures and protocols, writes SOPs pertaining directly to quality functions, reviews new or revised SOPs
- Maintains the company's FDA registration and compliance with FDA regulations
- Leads compliance-driven, competitive advantage, and quality improvement projects
- Approves and issues Certificate of Analysis
- B.S. in Chemistry, Biology, or equivalent experience
- 7+ years of experience in a GMP/GLP laboratory setting
- 3+ years of supervisory experience
- Must have a solid grasp of GMP/GLP/ISO regulations and standards
SGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, status as a protected veteran, or any other characteristics protected by law.
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, skills, and/or abilities 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.
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 receive a call back. 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.
Information will be kept confidential according to EEO guidelines.
