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.

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.

As the Quality Assurance Manager, you will be responsible for managing the Quality Assurance Department, ensuring compliance with protocols, federal regulations, industry guidelines, and company procedures.  Focuses on continuous improvement in the quality of the studies.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Manages QA systems functions at the site level.
• Has responsibility and authority for assuring the SGS Quality System is implemented, maintained, and continuously improved.  Ensures the SGS Quality System meets accreditation and certification requirements. 
• Structures and organizes the Quality Assurance department staff to ensure quality functions are being performed as required.
• Responsible for ensuring that Quality Assurance (QA) employees have attended all required training and are fully trained to perform his/her specific job functions.
• Oversees QA staff monitoring for on-site and off-site CRO services.
• Assists in hosting Sponsor and regulatory monitoring visits and works with the clinic to ensure documents are ready for sponsor monitors.
• Oversees and works with various departments in responding to CAPAs from Sponsor and Regulatory Audits, and oversees the internal CAPA and Deviation procedures.
• Oversees the review of study documents, CRF/source documents, and EDC for ongoing studies.
• Audits the company’s Standard Operating Procedures (SOPs), Work Instructions (WI), and Validation Plans (VP).
• Oversees vendor qualification and performs vendor qualifications, as needed.
• Coach cross-functional process and product improvement teams.
• Identify, acquire and use tools to evaluate the quality performance of the organization.
• Adheres to internal standards, policies, and procedures.
• Performs other duties as assigned.

Required

• Bachelors Degree (preferably in a scientific field)
• Minimum 5 years related experience in a regulatory environment
• 3+ years of supervisory experience preferred
• Working knowledge of Good Clinical Practices (GCP)
• Proficient in Microsoft Office Suite.
• Works well in a team environment and is able to maintain professional behavior.
• Effective communication, written, and verbal skills.
• Strong attention to detail.
• Well organized with a sense of responsibility for projects and time management.
• Ability to handle multiple competing priorities through effective resource management.
• Ability to maintain confidentiality and flexibility.
• Mathematical Skills: Intermediate preferred.
• Reasoning Skills / Abilities: Intermediate preferred.
• Computer Skills: Intermediate preferred.
• Occasional travel to Phoenix location ( 1 – 2 times per year)

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 callback.  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.