SGS ยท 1 day ago
Senior Manager, Quality Assurance
1801 N Glenville Dr, Richardson, TX 75081, USA
Full-time
Onsite
Senior Level
5+ years expSGS is the world's leading testing, inspection and certification company, recognized for sustainability, quality, and integrity. The Senior Manager, Quality Assurance will lead the quality assurance department for Cosmetics and Personal Care, ensuring compliance with regulations and continuous improvement in quality performance across all NAM sites.
OutsourcingSkill AssessmentTest and Measurement
Responsibilities
Establish and implement a Quality System Roadmap for Cosmetics & Personal Care, NAM with an associated gap assessment and remediation / continuous improvement plan
Build a Quality Assurance team capable of supporting the current and future business needs meeting both internal and external compliance / regulatory requirements
Develop and administer a risk-based GCP audit program for domestic and global clinical trials
Manages QA systems functions at the multi-site level
Oversee the planning, and execution of audits for external vendors including , but not limited to CROs, laboratories, clinical sites, as well as studies, and study documentation such as TMFs and CRFs
Review audit agendas, audit reports and audit responses within defined timelines
Actively leverage audit outcomes/trends to achieve sustained improvement in clinical trial conduct and reporting while championing the highest standards of compliance
Support business by overseeing management of quality Incidents and relevant actions
Establish, implement and report key performance metrics for the GCP/GLP audit program in support of periodic Quality Management Reviews
Development of new tools, Quality Initiatives and Quality Plans with implementation in matrix organizations
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
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 visit 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
Annual review of all policies, standard operating procedures, and work instructions
Ensures regulatory readiness at all times
Coach cross-functional process improvement teams
Qualification
Required
Bachelors Degree (preferably in a scientific field)
Minimum 5 years related experience in a regulatory environment
Knowledge of requirements for clinical studies for topical drug products
Working knowledge of Good Clinical Practices (GCP)
Experience with running clinical studies
Works well in a team environment and is able to maintain professional behavior
Demonstrate communication and collaboration skills with an ability to manage and influence stakeholders in a matrix environment effectively
Well organized with a sense of responsibility for project and time management
Ability to handle multiple competing priorities through effective resource management
Ability to maintain confidentiality and flexibility
Travel can be up to 15% and some might be international
Preferred
Supervisory experience (5+ years preferred)
CCRA certification desired but not required
Company
SGS
SGS is the inspection, verification, testing and certification company.
10001+ employees
H1B Sponsorship
SGS has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (19)
2024 (9)
2023 (13)
2022 (15)
2021 (18)
2020 (19)
Funding
Current Stage
Public CompanyTotal Funding
unknown2023-04-12IPO
Leadership Team
David Schramm
Operations Manager
Janet Vergis
Board Director
Recent News
2026-01-07
2026-01-06
Company data provided by crunchbase