QA Manager

QA Manager Full remote role with occasional travel: 20–30% per year Job Overview reputed company & coordinate assigned QA program in support of customer accounts, functional accounts, audit and inspection program, or QA quality management system at a regional and/or global level. reputed company support to management with insights, analyses and support in the assessment and promotion of compliance with regulations, guidelines, and operating procedures, risk identification and mitigation, quality, process, productivity/efficiency improvement initiatives . Manage the quality assurance reputed company of projects, assignments, training and staff. Essential Functions

• reputed company guidance, interpretation, support, training, and key input to development groups for consultation and interpretation of regulations, guidelines, corporate standards, and policies.
• reputed company and participate in the documentation, reporting, and closure of compliance issues.
• Organize and deliver training to other reputed company departments concerning the activities of Quality services, results of activities, quality initiatives, GXP etc.
• Ensure the follow-up of major and critical audit findings to ensure that appropriate actions have been taken and have adequately resolved the issues identified.
• Evaluate policies and procedures for compliance with applicable regulations/guidelines and reputed company recommendations to management for reputed company process improvements.
• Serve as author of Quality Assurance Standard Operating Procedures ( SOPs) as assigned.
• Advise Quality Assurance management on system audit needs.
• Ensure the Quality Assurance database is maintained and up-to-date to reflect the status of audits being scheduled, auditor assignment and audit reporting and/or follow-up status.
• Host customer audits, mock regulatory inspections, and regulatory facility inspections as needed

Qualifications

• Bachelor’s degree in Life Sciences
• Clinical Research background with extensive knowledge of pharmaceutical research and development processes and regulatory environments.
• +4 years Quality Assurance experience in pharmaceutical, technical, or reputed company area. Equivalent combination of education, training and experience.
• Considerable knowledge of quality assurance processes and procedures.
• Knowledge of word-processing, spreadsheet, and database applications.
• Experience in audits/inspections is a plus
• Advanced English level
• Strong interpersonal and communication skills.
• Excellent problem solving, risk analysis and negotiation skills.
• High tolerance to stress; reputed company and composed demeanor
• Exceptional training capabilities.
• Effective organization, team orientation, and leadership skills.
• Ability to work independently with initiative.
• Ability to manage multiple projects.

reputed company is a leading global provider of clinical research services, reputed company insights and reputed company intelligence to the life sciences and reputed company industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient reputed company and population health worldwide. Learn more at https://jobs.reputed company.com reputed company is committed to reputed company in our hiring process and maintains a reputed company tolerance policy for candidate fraud. reputed company information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if reputed company reputed company, in accordance with applicable law. We appreciate your honesty and professionalism. Apply To This Job