Director, Clinical Operations, Quality

Director, Clinical Operations, Quality is responsible for leading Clinical Quality Assurance (CQA) activities for assigned clinical development programs, including managing audits, quality issues, investigations, and inspections. This position requires an in-depth understanding and significant experience in GxP compliance, leadership, and communication skills. This role is accountable for ensuring the compliance of studies with Candel Therapeutics’ Standard Operating Procedures (SOPs), policies, and all applicable worldwide regulations and guidelines (e.g., FDA, European Union).

Essential Areas of Responsibility:

• Provide clinical development teams with professional expertise and guidance on GxP, GCP, GLP, and other applicable regulations to proactively identify compliance issues/risks and recommend mitigations.
• Liaise with various Candel departments and external parties, including contract auditors and investigator sites, to promote a high level of quality and consistency across and within programs; develop the risk-based audit and compliance strategy for assigned programs; assist project teams in implementing corrective and preventive actions; and enable teams to be inspection-ready in support of a culture of sustainable compliance
• Independently manage domestic and international audits of sites, documents, databases, vendors, or internal systems in compliance with GxP and Candel policies and procedures; assess the impact of audit findings on subject safety, data integrity, and business operations
• Develop and implement program-specific risk-based audit and compliance strategy and manage audits of sites, documents, databases, vendors, or internal systems in compliance with GxP and Candel policies and procedures
• Lead investigations into significant quality issues, scientific misconduct, and serious breaches of GxP; facilitate identifying root causes and developing appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting potential or confirmed violations to regulatory authorities
• Lead and support GxP health authority inspections; lead clinical development teams in preparation for announced inspections and provide GCP compliance technical support during inspections of investigator sites
• Analyze, report, and present metrics for assigned programs to development teams, R&D, and Quality management; recommend any required actions and monitor implementation
• Collaborate with the Clinical Operations teamto identify and mitigate GxP quality and compliance issues that could impact multiple programs or functional groups
• Escalate systemic and/or critical problems and recommend appropriate solutions to senior management for immediate and long-term resolution
• Other duties as assigned
  
  

Minimum Education, Experience, and Skill Requirements:

Education:

• BA/BS degree, preferably in biological sciences, engineering, or related field
  
  

Experience:

• Minimum of 12 years of experience in the pharmaceutical, biotechnology, or related healthcare industry
• Strong written and verbal communication skills; confidence in communicating across various platforms, including digital, written, and in-person presentations
• Superior project management and organizational skills; able to juggle many initiatives and competing priorities with tight deadlines
• Be an active collaborator and contributor to the overall team, with a strong capacity to work independently, efficiently, and proactively
• Advanced knowledge of GxP, ICH, GMP, and GCP requirements with an ability to apply them in a collaborative environment (solution-based)
• Advanced knowledge and skills to support data review and trend identification.
• Detail-oriented with a commitment to quality.
• Advanced critical thinking and problem-solving skills.
• Adaptable/flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet daily challenges confidently and professionally).
• Intermediate skills in Microsoft Word/Excel/PowerPoint and data review tools (e.g., Pt Profiles, report generating tools)
• Travel may be required up to 15% of the time
  
  

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