Job description

Company Description
Cellphire Therapeutics is a Rockville, MD-based biotechnology company focused on developing platelet-based products to save lives. Our lead product, Thrombosomes®, is a platelet-based freeze-dried hemostatic. Cellphire’s goal is to revolutionize hemostasis management through the development of the next generation of platelet-based products that will efficiently stop bleeding. We believe that our products will ensure platelet availability to all patients regardless of location or environment.

Position Summary: The Senior Clinical Quality Manager will lead the management of GCP quality activities in support of Cellphire clinical programs and clinical trials. Clinical Quality Manager will drive proactive quality management while ensuring compliance with Cellphire corporate policies, procedures, and applicable federal regulations for protection of the rights, welfare, well-being, and personal data privacy of subjects, data integrity, GCP, and FDA regulatory compliance as well as audits strategy. The Clinical Quality Manager will advise on quality management best practices in clinical research. As a primary GCP quality point of contact cross-functionally for the assigned clinical programs(s), the Senior Clinical Quality Manager will be responsible for establishing and executing a fit for purpose, phase appropriate audit program with the goal of submission ready quality data and first pass approvals by competent authorities for marketing authorization. This position will report to Chief Medical Officer and could be based remotely.

Job Description
RESPONSIBILITIES:

• Establish and maintain strong working relationships with internal and /or external stakeholders and team leads as assigned.
• Collaborate or guide clinical team on actionable insights during clinical activities execution as appropriate, QA and Clinical Development Operations Leadership and Senior Management.
• Contribute to the planning, management, and performance of GCP audits for Phase 1-3 clinical trials, e.g internal system/processes and clinical documents or data, including internal CAPA preparation, evaluation and follow up.
• Support the development, implementation and maintenance of QA systems and SOPs for GCP and GLP compliance.
• Represent Clinical Quality Assurance at cross-functional clinical program meetings, and operational activities. Provide appropriate Quality guidance on GCP compliance and continuous improvement matters to internal departments.
• Drive quality improvements and efficiencies along with risk mitigation based on CQA data analysis, operational performance data, knowledge of process.

Assist with the development, implementation and management of quality oversight plans, tools, and templates.

• Conduct QA reviews of essential documents including as applicable Clinical Protocols, Study Plans/Manuals, Clinical Study Reports, Investigator’s Brochures, for ensuring quality, accuracy and completeness. Lead, implement and maintain Cellphire’s GCP QA audit program, which may include qualification, routine and for-cause audits of CROs, investigator sites, laboratory and data management vendors as well as other clinical vendors to assess effectiveness of their QMS and compliance to approved clinical study protocols and contracts. Ensure quality incidents are fully investigated, root cause analysis is defined and that CAPA has been implemented and monitored for effectiveness.
• Coordinate GCP training content and delivery for internal employees. Maintain GCP training files within Cellphire’s learning management system.

Serve as a liaison with corporate QA department. Identify process improvement to build compliance into the design and conduct of clinical activities.

• Actively support the development and deployment of activities to ensure documentation is always audit ready.
• Report on key metrics (KPIs), quality metrics, periodic quality reports and audits as needed.
• Monitor contractual quality measures (e.g., federal contracts) and assess Cellphire’s ability to conform to our own SOPs.
• Maintain current working knowledge of all applicable regulations.
• Other duties or special projects as assigned or required.

Supervisory Duties: may have up to 1 direct report

• Qualifications

Education: BS/MS or above in scientific, healthcare, or biotechnology related discipline

Experience:

• Minimum 5 years’ experience with minimum of 2 years specifically in GCP focused clinical quality assurance.
• Minimum of two (2) years of managing clinical trials (Phase 1-3)
• Direct experience in global clinical trial compliance, clinical data management or Biostatistics is a plus.
• Strong knowledge and interpretation of GxP regulations in drug development from pre-clinical to post marketing safety particularly US FDA/EU and ICH regulation and guidelines.
• Direct experience with competent authority inspections such as US FDA GCP BIMO Inspections (Sponsors, CROs, etc.,)

Specialized Knowledge:

• Strong working knowledge of GCP and GLP regulations/guidelines (ICH/US FDA/ ISO) and Quality Management Principles and AVOCA industry standards
• Clinical Research certification a plus
• Strong knowledge of Microsoft Word, Excel, PowerPoint, and graphics software such as Visio.

Additional Information
Domestic/International Travel: 10-25%

Physical Demands: Should be able to sit at the desk or stand at a computer for prolonged periods.All your information will be kept confidential according to EEO guidelines.

Job Type: Full-time

Pay: $125,000.00 - $150,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Tuition reimbursement
• Vision insurance

Schedule:

• Monday to Friday

Supplemental pay types:

• Bonus pay

Ability to commute/relocate:

• Rockville, MD 20850: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Required)

Experience:

• GCP Clinical Quality: 5 years (Required)
• Clinical trials management: 2 years (Required)

Work Location: Hybrid remote in Rockville, MD 20850

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