Sr. Manager, Clinical Quality Assurance

Overview of Role:

Collaborate closely with Regulatory Affairs, QA, R&D and other cross functional teams within Summit 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 GxPs and regulatory requirements and guidelines.

Role and 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.
• Managing Audits which include Clinical Sites and Vendor Qualification
• 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 RD/PV 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 in support of the Quality Systems internal audit program

Experience, Education and Specialized Knowledge and Skills:

• Bachelor's Degree in Life Sciences, Pharmacy or Nursing required and Master's Degree or other advanced degree preferred
• 5 or More Years Quality Assurance experience and or Clinical Operations involvement in regulated activities or equivalent experience required.
• 5 or More Years broad understanding of global expectations of Health Authorities in the management of clinical trials preferred
• 5 or More Years thorough and extensive knowledge of international GCP/GLP regulations including FDA/EU GCP, ICH, pharmacovigilance, new drug regulations, other key HA guidance’s, and current industry practice preferred
• Proficiency in Mandarin Chinese (spoken and written) is highly desirable
• Ability to travel up to 20%
• Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable
• Strong computer and database skills
• Attention to detail, accuracy and confidentiality.
• Clear and concise oral and written communication skills
• Excellent organizational skills
• Critical thinking, problem solving, ability to work independently.
• Must be able to effectively multi-task and manage time-sensitive and highly confidential documents.
• Communicate effectively and articulate complex ideas in an easily understandable way
• Prioritize conflicting demands.
• Work in a fast-paced, demanding and collaborative environment.
• Fluent in Madrin highly preferred yet not required.