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Manager/Sr. Manager, QA and Regulatory Affairs

Company: BioClinica
Location: Princeton
Posted on: August 5, 2022

Job Description:

At Clario, we put people first, always. We are united and driven by patients, committed to making a difference, and we are always looking for the best talent to help us transform lives. Clario seeks a Manager/Sr Manager, Quality Assurance & Regulatory Affairs to join our QA/RA leadership team. Manage assigned team(s) of Quality Assurance Auditors and Quality Assurance Analysts Maintain and develop an effective organization through the selection, training, and mentoring of employees. Establish and maintain key performance indicators to monitor team performance and develop strategies to improve performance and efficiency. Monitor the progress of assigned staff to ensure department goals and training are achieved. Evaluate department hierarchy to support the continued growth of the department and enhancement of employee satisfaction. Support the continued development of lead and senior positions through project and resource assignments. Support the audit program for applicable processes and systems Oversee scheduling, planning and resource assignment for audits Perform internal and vendor audits, quality reviews and gap analyses of company processes and systems to determine compliance with applicable regulatory requirements, guidance and procedures Oversee the mitigation and closure of audit observations by following up with applicable stakeholders to determine appropriate and timely responses Manage client audits by providing overviews of relevant topics and liaising with company employees for appropriate audit support Manage the review of system development and validation deliverables Cultivate and maintain effective working relationship with functional groups involved in the process Assign review of validation deliverable review to quality assurance resources Conduct quality review of system validation deliverables against regulatory requirements, guidance and internal procedures Develop and maintain standard operating procedures and/or work instructions to support the quality review process of system validation deliverables Support continuous improvement of company processes and standards Collaborate with operational and quality assurance leadership to identify, prioritize and lead improvement initiatives Facilitate reporting, tracking and resolution of quality issues, including support of root cause analysis and identification of appropriate corrective and preventative actions. What we seek - Excellent organizational, interpersonal, verbal, and written communication skills Strong documentation and organizational skills Ability to manage multiple tasks effectively & efficiently Ability to travel 10% Bachelor's Degree in Computer Science, Information Technology, Health/Life Sciences or Biomedical Engineering Minimum 10 years relevant experience in a Quality Assurance capacity with a focus on GxP and computer system compliance. GCP experience preferred. 7 years of managerial experience Expertise in software development concepts, computer system validation, data integrity, cloud computing, 21 CFR Part 11 and Annex 11. What we offer - Competitive compensation package Attractive benefits (security, flexibility, support and well-being) Excellent Onboarding program and ongoing educational opportunities Engaging employee resource programs We value the contribution each of our people brings. It's only through our people that we can continue to innovate technology that will shape the future of clinical trials. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. All are welcome - join us The duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned, as required. Clario reserves the right to amend or change this job description to meet the needs of Clario. This job description and any attachments do not constitute or represent a contract.

Keywords: BioClinica, Trenton , Manager/Sr. Manager, QA and Regulatory Affairs, Executive , Princeton, New Jersey

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