Officer, QA (Oncology) at Hikma Pharmaceuticals conducting analytical research and ensuring product compliance. Collaborating in a culture of progress in the pharmaceutical industry in Algiers.
SI
Hybrid Manager, Clinical Quality Assurance
Posted 4 months ago
About the role
- Manager, Clinical QA providing compliance-related advice in oncology at Summit Therapeutics. Collaborating with key stakeholders to ensure end-to-end quality management of clinical studies.
Responsibilities
- 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
- Ensure end-to-end quality management through proactive compliance based on Clinical Development Plan (CDP)
- Liaise with the Global Audits and Compliance function to provide lessons learned from audits and inspections to program teams and support implementation of corrective actions
- Support formal investigations of issues as they arise, ensuring timely escalation to line management if critical incidents are not resolved in due course
- Identify areas of continuous process improvement and engage QA and key stakeholders as necessary
- Manage inspection preparation and follow-up post inspections
- Support development and implementation of study/program-specific quality plans to ensure proactive management of quality
- Perform internal audits as applicable
Requirements
- 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 guidances, 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
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