Job Description
How you’ll contribute:
- Lead development and execution of the Clinical Quality strategy while ensuring that it aligns with Company’s business strategy, GCP/GLP/GVP standards, and FDA/EMA/ICH requirements
- Develop, implement and monitor phase appropriate GCP/GLP/GVP Quality programs, policies and procedures to ensure compliance with applicable regulations
- Develop, implement and execute a risk-based audit strategy for clinical and non-clinical studies
- Lead and manage GLP/GCP/GVP audits program including oversight of consultant mediated and/or self-conducted Vendor, System, Study, and Process audit
- Providing quality oversight and compliance support to all GLP non-clinical and clinical development programs including the development of strategic clinical quality oversight plans
- Serve as a member of clinical study teams, providing compliance guidance, to achieve continuous quality improvement and effective quality assurance
- Implement tolerance limits, metrics and key performance indicators to drive quality compliance and continuous improvement
- Provide day-to-day quality and compliance support, including issue management (triage/investigation/actions)
- Assist and advise in the development of CAPA plans in response to Quality events / audits / inspections and follow-up on CAPAs
- Participate in the evaluation and selection of CROs and other GLP/GCP/GVP service providers and establish Quality Agreements, as required
- Provide training sessions and mentor teams on topics related to GLP/GCP/GVP quality and related global regulations
- Review key non-clinical, safety and clinical documents including protocols/amendments, reports, study plans and regulatory documents
- Maintain an inspection awareness culture leading to a successful Inspection Readiness Program
- Establish Quality management governance and escalation structure and periodically report the state of R&D Quality and compliance to management at the Quality Management Review
Skills and experience you’ll bring:
- Bachelor’s degree in life sciences, nursing, or related field. Advanced degree (MS or MBA) preferred
- A minimum of 15+ years of experience in the biopharmaceutical/pharmaceutical industry
- Working knowledge of relevant FDA, EU, ICH guidelines and regulations
- Experience with First in Human trial management
- Extensive knowledge and understanding of ICH E6 GCP Guideline, FDA and EU Requirements
- Experience and understanding of Data Integrity requirements and electronic systems used in Clinical trials
- Direct experience in managing Health Authority GCP Inspections. Experience supporting BIMO inspections is preferred
- Proven experience with developing strong partnerships with cross functional key stakeholders to ensure that strategic business goals are met through the sharing of knowledge and teamwork
- Extensive knowledge and understanding of all related study monitoring activities
- Comprehensive understanding of the infrastructure and operational characteristics of CROs and centralized services
- Strong problem solving and critical thinking skills, including an ability to combine attention to detail with a big picture perspective
- Ability to drive results on time and take ownership and accountability for shared information
- Strong communication and influencing skills, as well as problem solving ability to evaluate quality matters and make decisions utilizing risk-based approach
- Experience with authoring and reviewing clinical regulatory filings
- Ability to travel up to 15%
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