Manager, Good Clinical Practices

Alcon Research•Fort Worth, TX

4d•Onsite

About The Position

This role is part of Alcon's Quality & Regulatory Affairs function, a team that ensures our products are in compliance with global, local, and internal regulations and meet the strictest standards of quality as we help people see brilliantly. The Manager, Good Clinical Practices (GCP) is primarily responsible for leading compliance activities, providing technical expertise, and driving quality improvement projects. You will manage external audits, ensure site preparedness, and coordinate Corrective and Preventive Action (CAPA) processes. As a Manager, Good Clinical Practices supporting the QA Compliance Team in Fort Worth, TX, Durham, NC, Johns Creek, GA, or Lake Forest, CA, a typical day will include: Manage individual projects, applying advanced knowledge to achieve objectives and impact project performance and operational efficiency. Oversee day-to-day operations, ensuring productivity and alignment with departmental objectives. Make operational decisions, managing programs, resources, and schedules. Ensure implementation of quality management systems at every stage of process/operations. Implement quality assurance regulations and write, revise, review and approve standard operating procedures. Perform and support inspections/audits of processes and documents associated with studies/facilities/ equipment/suppliers/vendors to ensure that activities comply with applicable GCP/GLP regulatory requirements, standard operating procedures, and study protocols. Manage, support, and facilitate internal and external audits/regulatory inspections, ensure site preparedness, and coordinate Corrective and Preventive Action (CAPA) processes. Report potential issues with quality, compliance, ineffective processes/procedures, and deviations and recommend appropriate corrective & preventive actions. Lead implementation of new regulations, regulatory guidance, and international standards. Ensure adherence to Good Practice (GxP) regulations by following Standard Operating Procedures (SOPs), maintaining accurate documentation, ensuring rigorous quality, and completing required training. Commitment to continuous improvement and compliance with regulatory requirements. All associates must adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training. Associates are responsible for meeting their individual job requirements and contributing to the overall compliance of the organization. Compliance with regulatory requirements and a commitment to continuous improvement are essential to our operations.

Requirements

Bachelor’s Degree or Equivalent years of directly related experience (or high school +13 yrs; Assoc.+9 yrs; M.S.+2 yrs; PhD+0 yrs)
The ability to fluently read, write, understand and communicate in English
5 Years of Relevant Experience

Nice To Haves

Knowledge of ISO 14155, ICH E6, Medical Device EU, FDA regulatory requirements, and Declaration of Helsinki
Validated GCP audit track record
Good analytical skills and judgment
Advocate for outstanding quality and compliance standards – does not compromise on customer expectations and regulatory requirements

Responsibilities

Manage individual projects, applying advanced knowledge to achieve objectives and impact project performance and operational efficiency.
Oversee day-to-day operations, ensuring productivity and alignment with departmental objectives.
Make operational decisions, managing programs, resources, and schedules.
Ensure implementation of quality management systems at every stage of process/operations.
Implement quality assurance regulations and write, revise, review and approve standard operating procedures.
Perform and support inspections/audits of processes and documents associated with studies/facilities/ equipment/suppliers/vendors to ensure that activities comply with applicable GCP/GLP regulatory requirements, standard operating procedures, and study protocols.
Manage, support, and facilitate internal and external audits/regulatory inspections, ensure site preparedness, and coordinate Corrective and Preventive Action (CAPA) processes.
Report potential issues with quality, compliance, ineffective processes/procedures, and deviations and recommend appropriate corrective & preventive actions.
Lead implementation of new regulations, regulatory guidance, and international standards.
Ensure adherence to Good Practice (GxP) regulations by following Standard Operating Procedures (SOPs), maintaining accurate documentation, ensuring rigorous quality, and completing required training.
Commitment to continuous improvement and compliance with regulatory requirements.
Adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training.
Meet individual job requirements and contribute to the overall compliance of the organization.