What are the responsibilities and job description for the Senior Director, Quality GCP position at Clinical Dynamix, Inc.?

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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Senior Director, Quality GCP

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