Manager, Clinical Quality Assurance (GCP)

Overview of Role:

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.

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

• 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

Experience, Education and Specialized Knowledge and Skills:

• Bachelor's Degree in Life Sciences, Pharmacy, or Nursing required

• Master's Degree or other advanced degree preferred

• Minimum of 5+ or more years Quality Assurance experience and or Clinical Operations involvement in regulated activities or equivalent experience required

• 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’s, and current industry practice preferred

• 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

The pay range for this role is $139,000-$163,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.