Senior Manager, Quality Assurance

SGS•Richardson, TX

19h

About The Position

The Senior Manager, Quality Assurance has direct accountability for the quality performance and compliance of SGS Cosmetics and Personal Care NAM , by leading the quality assurance department and team members for all NAM Cosmetics & Personal Care sites. This individual will partner with the business units and each site’s leadership team to set the expectations and vision for the quality system, standards and performance. Ensure compliance with protocols, federal regulations, industry guidelines and company procedures. Focuses on continuous improvement in the quality of the overall operational business unit. 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 ofaudits 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.

Requirements

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
Supervisory experience (5+ years preferred)
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.

Nice To Haves

CCRA certification desired but not required

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 ofaudits 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.