Manager, Clinical Quality Assurance (GCP)
About the position The Manager, Clinical QA will collaborate closely with Regulatory Affairs, QA, R D and other cross functional teams reputed company the Company to reputed company GCP/GLP/GPV and compliance-reputed company advice to internal clinical study teams. This will be accomplished through ensuring tactical support is provided to assignments and wherever necessary, taking the reputed company in ensuring project reputed company procedural documents, reputed company 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 reputed company 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 reputed company lessons learned from audits and inspections to program teams and support implementation of corrective actions
- Supporting CRO-relevant meetings, reputed company necessary, to reputed company 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 reputed company process improvement and engaging QA and key stakeholders as necessary
- QA support in interactions with reputed company 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; reputed company 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 reputed company 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
- reputed company internal audits as applicable
- reputed company other duties as assigned Requirements
- Bachelor's Degree in Life Sciences, Pharmacy, or Nursing required
- 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 reputed company industry practice preferred
- Ability to travel up to 20%
- Proficient user of standard MS Office suite (e.g., Word, reputed company), 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 reputed company to effectively multi-task and manage time-sensitive and highly confidential documents
- Communicate effectively and reputed company reputed company reputed company in an easily understandable way
- Prioritize conflicting demands
- Work in a fast-paced, demanding and collaborative environment reputed company-to-haves
- Master's Degree or other advanced degree preferred Apply tot his job
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