GeneCoda has been engaged to identify and evaluate candidates, for a Director of Clinical, Regulatory and CMC Quality Assurance located in the Research Triangle Park, NC marketplace.
About Our Client:
Our client is an immuno-oncology company developing novel therapies that activate a patient’s immune system to fight cancer. Our client is filing several IND’s to advance multiple products into early phase clinical programs within the next year prompting the recruitment of this opportunity.
Our client is seeking a Director of Clinical, Regulatory and CMC Quality Assurance to manage the company’s clinical, regulatory and CMC quality function. This role will oversee and manage the GCP audit management function both internally and externally for a robust and expanding clinical stage portfolio. In addition, this individual will coordinate regularly with clinical development, CMC and regulatory functions, as required to establish and manage GCP compliance activities.
- Develop and execute Clinical QA plans to meet regulatory compliance goals.
- Perform audits of investigator sites, documents, databases, vendors or internal systems.
- Conduct audits of clinical and regulatory documents, ensuring the quality, accuracy and completeness of various documents, including but not limited to Trial Master Files (TMFs), Clinical Study Reports (CSRs), Investigator Brochures, and Integrated Summaries.
- Provide input, guidance and expertise in ensuring quality operations to support clinical efforts and ensure robust, compliant patient supply.
- In conjunction with regulatory and Clinical Development, provide input for quality oversight and on-going relationships with service providers.
- Provide guidance for significant events (deviation, adverse events, non-compliance status, other) that could adversely affect product quality, compliance status, or pose significant business risk.
- Maintain databases for audit observations and corrective action and preventative actions (CAPAs); Track, review, approve, and assess the adequacy of CAPAs.
Education: Bachelor of Science degree in biology or related field. An advanced, post-graduate degree is desirable.
Experience and Qualifications:
- 6+ years of experience and familiarity with general clinical trial best practices for data management, statistics and Good Clinical Practice (GCP) guidelines
- Familiarity with Federal regulations affecting clinical trial data management and statistical work such as relevant FDA regulations and 21 CFR Part 11
- Background, experience and knowledge of the biologic drug development process.
- Established expertise in GxP systems. Extensive knowledge of regulations and standards (e.g. ICH, CFR).
- CMC quality experience, preferred.
- Passion for problem solving and teamwork.
- Strong collaborative skills, team player mentality.
- Effective decision-making and problem-solving
- Strong organizational skills.
- Ability to prioritize, organize and manage multiple projects simultaneously.
- Excellent interpersonal skills.
- Excellent verbal and written communication skills.
- Willingness to travel up to 10% of the time as work requires.
GeneCoda refers qualified applicants for all jobs without regard to race, color, religion, creed, age, sex, disability, marital status, national origin, pregnancy, family medical history or genetic information, sexual orientation or preference, Vietnam Era Veteran status or other protected military status or any other status protected by federal, state or local law.