Associate Director/Director, Clinical Quality Assurance

at Rain Oncology
Newark, CA
Position: Associate Director/Director, Clinical Quality Assurance
Are you ready to join a growing, innovative, precision oncology powerhouse? Rain Therapeutics is committed to building a passionate core team of scientific, clinical, regulatory, and business leaders to bring new targeted 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.
Our team members are passionate about helping patients! If you’re looking to be a part of a lean and nimble team with significant responsibility, and contribute constructively across departments in an entrepreneurial position, we urge you to consider joining our team.
Overview:
The Associate Director/Director, Clinical Quality Assurance (CQA) is a critical team member is responsible for supporting the implementation of a risk-based Good Clinical Practice (GCP) audit program to assure quality compliance oversight for Rain Oncology Clinical Trials. Responsibilities include representation at the clinical study teams, assessing the effectiveness of GCP processes, conducting GCP audits, supporting the developing, tracking, and trending of Quality metrics, creating and presenting actionable reports, presenting data to Senior Management, and supporting or hosting GCP Health Authority inspections.
Principle Responsibilities and Duties:
Quality representative for the clinical study teams
Develops the clinical development program audit plans
Develops the annual GCP audit schedule
Conducts and/or coordinates for audits (both on-site and remote) of clinical investigator sites, clinical vendors (e.g. Central Safety Laboratories, Phase I Units/Clinical Pharmacology Units (CPUs), Bioanalytical Laboratories), and internal processes
Collaborates cross-functionally to ensure systems, processes, and their outcomes comply with GCP global regulatory requirements, standards, and guidelines
Manages issues in clinical programs to ensure compliance requirements are met. Confirms that GCP corrections, corrective, and preventive actions are completed in a timely manner
Create clinical site and vendor metrics risks reports as a component of Rain Clinical Quality Risk-based Oversight Program
Reviews and evaluates key clinical system validation/qualification packages for completeness, accuracy, and compliance with applicable regulatory requirements
Train CQA contractors and auditors on CQA Sops and audit standards
Conducts annual internal GCP training and education in accordance with global GCP standards
Authors, revises, and implements CQA written procedures [e.g., Standard Operating Procedures (SOPs), Work Instructions, etc.]
Assists in preparation activities for GCP Health Authority inspections to ensure successful outcomes of inspections from conduct through the coordination of response resolution
Supports and/or hosts GCP Health Authority inspections
Assists in follow-up on inspection commitments, post-inspection activities, corrective, and preventive actions, and resolution of conflicts for timely closure
Supports CQA projects
Maintains audit logs, audit files, and vendor files
Additional Competencies, Knowledge, and Skill Requirements:
Knowledge of regulatory authority inspection practices internally, externally, domestic and internationally
Experience managing and supporting regulatory authority inspections of clinical research activities
Leadership experience and mentoring skills to ensure all Rain team members have a firm understanding of Rain inspection process
Knowledge and application of international GCP regulations and ICH Guidelines
Experience, Education, Training, Traits:
Bachelors degree in a scientific field
At least 10 years experience in a Biotechnology/Pharmaceutical CQA role with CQA auditing experience
Strong knowledge of global GCP regulations and standards
Attention to detail in all aspects of work
Experience with Health Authority Inspections preferred
Excellent collaboration skills
Ability to work independently as well as in teams
Excellent verbal and written communication skills
Demonstrated ability to effectively organize and execute tasks
Computer proficiency with Word, Excel, and PowerPoint
Ability to work in a fast-paced, dynamic environment
Must be able to travel up to 30% time
The pay range that the Company reasonably expects to pay for this position is $187,200 – 217,350; the pay ultimately offered may vary based on objective considerations, including job-related knowledge, skills, experience, and education. An annual cash bonus and equity grants may be provided as part of the overall compensation package, in addition to a full range of financial, health and wellness benefits, dependent on the position offered.
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.