Sr. Manager/AD, R&D Quality

Role Summary

Reporting to the Executive Director, R&D Quality the Sr. Manager/AD, R&D Quality is responsible for providing Quality Assurance oversight by executing audits, ensuring compliance with GxP regulations, managing risk, supporting inspections, driving issue resolution, monitoring compliance metrics, updating procedures, conducting regulatory intelligence, and providing training.

Responsibilities

• Provide Quality Assurance strategy and oversight to ensure compliance with GCP, GLP, cGLP, and/or GVP regulations across studies, projects and programs
• Support development and execution of GxP vendor audits according to the vendor audit plan
• Support development and execution of clinical investigator site audits according to annual audit plans
• Support development and execution of internal audits according to internal audit plans
• Actively identify and contribute to the GxP Risk Management processes
• Partner with the cross functional GxP teams to develop and improve Viridian processes and procedures such as Policies, SOPs, Work Instructions and Forms, and trial documentation such as protocols, reports, transfer plans, system and study manuals, etc.
• Lead inspection readiness and support sponsor, vendor and site GCP/GLP/GVP regulatory inspections globally.
• Drive GxP quality issue compliance through the identification and documentation of deviations, CAPAs, effectiveness checks, and change controls.
• Monitor, analyze, and report compliance metrics to management as appropriate, and guide teams on improvements.
• Assist with or provide GCP/GLP/GVP training to employees as appropriate

Qualifications

• Requires a Bachelor’s degree in Life Sciences of related discipline is required (Advanced degree a plus) with 8+ years of biotech/pharmaceutical experience
• Clear record of success in R&D QA in the biotech/pharmaceutical industry
• Thorough understanding of FDA, ICH and EMEA guidelines and regulations
• Excellent time management skills and the ability to work with a sense of urgency
• Demonstrated leadership and collaboration skills in a cross-functional project team
• Strong oral and written communication including the ability to present information clearly and logically
• Ability to anticipate and address issues, prioritize, and manage multiple projects to meet critical deadlines
• Strong attention to detail and problem-solving skills
• Works effectively in a team environment
• Strong commitment to ethical standards
• Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
• The salary range for this position is commensurate with experience