Clinical Quality Assurance/CQA, GCP Quality
Grade Level: Associate Director
Are you ready to join a growing, innovative, precision oncology powerhouse? Rain Therapeutics is committed to building a passionate team of core scientific, clinical, regulatory, and business leaders to bring new therapies for cancer patients struggling with limited treatment options. Our focus has been and will continue to be new oncology therapeutics based on targeting the biological drivers of the cancer, regardless of tumor type.
We envision our company culture driven by spirited individuals with an entrepreneurial mindset who want to solve problems, and leaders who are sufficiently experienced to know success in the drug development industry comes with great challenges; it will never be a straight line. We are looking for team members that are passionate about helping patients at the worst time in their lives. Rain Therapeutics strongly believes that we are tremendously fortunate to aim our careers towards having a direct impact on patients, and we intend to fully leverage this opportunity with aggressive developmental timelines for a multitude of pipeline programs, all unified across a precision oncology strategy.
Summary of Key Performance Objectives:
The Associate Director of Clinical Quality Assurance/CQA, GCP Quality will provide quality and compliance support across Rain Therapeutics clinical projects. This person would lead and will be the subject-matter-expert in GCP, collaborate with Clinical Operations and Nonclinical in the development of Policies, SOPs and programs that are phase appropriate for GCP and GLP activities. Additionally, the position will be responsible for designing and implementing quality plans and include external GCP audits of clinical services providers, CROs, suppliers, and investigator sites, as well as internal audit of clinical processes and procedures.
The individual must have the ability to work completely independently and also as an effective and engaged director in a fast-paced environment. Strong initiative and follow through are essential for this job. This position Reports to the Vice President of Quality.
Job Duties and Responsibilities:
- Must work independently and direct activities in support of all Clinical studies.
- Formulates GCP compliance strategy and Systems and delivers support to the clinical team for assigned programs or studies.
- Collaborate with Clinical Operations and Development on quality and compliance strategy via representation on the study teams, and leadership on issue management and escalation to Senior Management.
- Manages the GCP compliance risk areas and also supports and implements risk mitigation measures for clinical and future Commercial activities.
- Responsible for audit strategy for assigned programs or studies.
- Plans and leads GCP compliance audits (US and international), including clinical investigator sites, contract clinical laboratories and CROs to determine compliance status and identify compliance risks.
- Reports audit findings to management with recommendations for resolution and verifies appropriate corrective actions have been implemented and documented.
- Partners with Clinical Nonclinical and Regulatory Affairs stakeholders regarding compliance issues and provide compliance guidance to audited parties to encourage process improvement.
- Serves as a resource in the interpretation of GCP regulatory requirements and expectations.
- Performs QA reviews of project‐related clinical study documents/Deviations/Change Controls and CAPAs.
- Supports Product investigations and SAEs/SUSARs.
- Leads inspection readiness efforts (BIMO).
- Supports the development and implementation of standards, policies, and procedures for GCP regulatory compliance. Manages with Clinical the GCP SOPs.
- Supports the TMF and filing of INDS and NDAs. Responsible for reviews of regulatory clinical sections.
- Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks.
- Ability to multi-task and shift priorities quickly while working under tight deadlines.
- Skilled in developing collaborative internal and external relationships.
- Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
Critical Job Skills:
- At least 8 years of experience in GCP Quality Assurance.
- Excellent knowledge of risk-based quality systems approaches consistent with ICH E-6 for Good Clinical Practice (GCP).
- Experience with all phases of clinical trials.
- Strong knowledge of Good Clinical Practices (FDA and ICH) and the ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible and constructive manner.
- Attention to detail as well as a crisp, clear and concise style in written and oral communications.
- Demonstrated ability to work independently and flexibly in a fast-paced, high growth environment and management experience.
- GLP knowledge a plus
Required and Preferred Education:
- BS/BA degree in scientific discipline from an accredited college or university with advanced degree preferred.
Physical Working Conditions:
- Ability to travel both domestic and internationally, as needed (~40%Travel is expected)
Rain Therapeutics is an equal opportunity employer, and we’re proud of our ongoing efforts to foster diversity & inclusion in the workplace. Individuals seeking employment at Rain are considered without regard to race, color, religion, national origin, age, sex, gender, gender identity, gender expression, sexual orientation, marital status, medical condition, ancestry, physical or mental disability, military or veteran status, or any other characteristic protected by applicable law.