Manager, Clinical Quality Assurance (GCP)

Role Summary

The Manager, Clinical QA will collaborate closely with Regulatory Affairs, QA, R&D and other cross-functional teams within the Company to provide GCP/GLP/GPV and compliance-related advice to internal clinical study teams. This will be accomplished through ensuring tactical support is provided to assignments and wherever necessary, taking the lead in ensuring project related procedural documents comply to relevant GxP’s and regulatory requirements and guidelines.

Responsibilities

• Partnering and collaborating with key stakeholders (R&D teams) to ensure that appropriate Quality support is provided to Summit Clinical and pre-clinical programs
• Ensuring end-to-end quality management through proactive compliance based on Clinical Development Plan (CDP)
• Liaising with the Global Audits and Compliance function to provide lessons learned from audits and inspections to program teams and support implementation of corrective actions
• Supporting CRO-relevant meetings, when necessary, to provide quality overview/ training to relevant stakeholders
• Providing support during the development and execution of Corrective and Preventive Actions (CAPAs). Coordinating and reviewing CAPAs to ensure adequate CAPAs are defined, implemented, and closed.
• Support formal investigations of issues as they arise, ensuring timely escalation to line management if critical incidents are not resolved in due course
• Identifying areas of continuous process improvement and engaging QA and key stakeholders as necessary
• QA support in interactions with internal and external contacts and Health Authorities (HA), as appropriate. In collaboration with the Global QA team, ensure inspection management by assisting in preparing program teams for FDA, EU, and key HA pre-approval and sponsor-monitor inspections; provide inspection management support and follow-up post inspections.
• Support in providing interpretation of regulations and company process standards, guidelines, policies, and procedures to personnel for assigned programs or for continuous improvement projects
• Supporting or leading development and driving the implementation of study/program-specific quality plans to ensure proactive management of quality
• Supporting rectifying any necessary vendor-relevant issues identified for the assigned program
• Ensuring that protocols for assigned programs can be operationalized and address potential risks with key stakeholders
• Perform internal audits as applicable
• All other duties as assigned

Qualifications

• Required: Bachelor's Degree in Life Sciences, Pharmacy, or Nursing
• Preferred: Master's Degree or other advanced degree
• Required: Minimum of 5+ years Quality Assurance experience and/or Clinical Operations involvement in regulated activities or equivalent
• Preferred: Broad understanding of global expectations of Health Authorities in the management of clinical trials
• Preferred: Thorough understanding of international GCP/GLP regulations including FDA/EU GCP, ICH, pharmacovigilance, new drug regulations, other key HA guidance, and current industry practice
• Required: Ability to travel up to 20%
• Preferred: Proficient in MS Office; experience with electronic document management systems and document review tools

Skills

• Strong computer and database skills
• Attention to detail, accuracy and confidentiality
• Clear and concise oral and written communication
• Excellent organizational skills
• Critical thinking, problem solving, ability to work independently
• Ability to multi-task and manage time-sensitive, confidential documents
• Effective communication and ability to articulate complex ideas clearly
• Ability to prioritize conflicting demands and work in a fast-paced, collaborative environment

Education

• Bachelor's Degree in Life Sciences, Pharmacy, or Nursing
• Master's Degree or other advanced degree (preferred)

Additional Requirements

• Travel up to 20%