Director of Clinical QA - Permanent - Remote
Proclinical Staffing is seeking a Director of Clinical QA to join a cutting-edge biotech company. This is a permanent role with the opportunity to work remotely.
Primary Responsibilities
The Director, Clinical Quality Assurance is an integral part of the global Clinical Quality Assurance function, supporting the teams and the global quality systems. This includes ensuring clinical trials and associated records are complete and up to date in accordance with current Good Clinical Practices (GCP) and regulatory expectations and the maintenance of the quality management systems, such as SOPs, training and electronic records management. The Director, Clinical Quality Assurance will assist with regulatory inspection readiness, inspection management, and internal audits, including independent conduct of trial related audits.
Skills & Requirements:
- Some travel required (up to 25%).
- BS in life sciences or equivalent experience
- 5+ plus years direct and relevant clinical quality assurance experience (GCP) in oncology studies.
- 10+ years in pharmaceutical/biotechnology industry and/or CROs,
- Broad knowledge of clinical processes and procedures, electronic document systems Good Clinical Practice and associated regulations.
- Experience with regulatory inspections and inspection readiness
- Direct GCP auditing experience
- Strong interpersonal, written and oral communication skills
- Must be able to build partnerships and diplomatically work with other departments.
- Proficiency in the use of relevant computer systems including MS office.
- ASQ Certification
- Experience with European regulations is a plus.
- Experience with Pharmacovigilance QA is a plus
The Director of Clinical QA will:
- Maintain and support Clinical Quality Assurance (CQA) Systems: training, SOPs, and records management
- Provide support and expertise in GCP/Pharmacovigilance (PV) related regulatory inspections.
- Support proper maintenance of the clinical documentation databases and systems.
- Develop and supervise the GCP/PV related annual and project audit schedules.
- Perform or supervise GCP/PV related internal, vendor and investigator site audits.
- Perform periodic internal GCP trainings.
- Monitor CAPA execution to ensure accuracy and completeness.
- Generate and oversee quality metrics and advise management, as appropriate
- Represent CQA in assigned projects and cross functional groups to provide support and compliance for ongoing and planned clinical trials and initiatives.
- Support clinical development by reviewing and approving clinical documents and regulatory submission documents in accordance with procedures.
- Comply with all Corporate Policies, rules, and regulations as set out and communicated by the company pursuant to good business practice.
- Must adhere to core values, policies, procedures, and business practices.
- Perform miscellaneous duties as assigned.
If you are having difficulty in applying or if you have any questions, please contact Christina Chung at (+1) 857-233-9215 or c.chung@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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