Turning Point Therapeutics is looking for an experienced Manager, Clinical Quality Assurance, who will take a leadership role in developing the Clinical Quality Assurance (CQA) systems that will ensure GCP compliance.
The ideal candidate will have hands-on experience in clinical audits, regulatory inspections and come from a clinical Quality Assurance background. He/she will provide the vision and drive the implementation of the systems required to ensure GCP compliance and inspection readiness through process improvements across clinical development, clinical audits/inspections, the implementation of corrective and preventive actions (CAPAs), and revision/implementation of essential standard operating procedures (SOPs). This position reports to the Senior Director, Quality Assurance.
- Perform audits of investigational sites, CROs/Service Providers, documents and internal system and processes, in order to ensure compliance with regulatory requirements and company policies and procedures; Organizes, leads and participates in contracted audits
- Prepare written audit reports and communicates findings and recommendations and evaluate the adequacy and completeness of corrective and preventative action plans.
- Act as the primary point of contact with clinical development and clinical operations teams to provide GCP and process related guidance and support; works with teams to investigate and resolve clinical study related GCP compliance, deviations and process related issues, providing recommendations for solutions and CAPAs as needed.
- Perform regular, in-depth GCP audits of study data, documentation, informed consents, clinical study reports, data management, statistical analyses, and ethics committee submissions as appropriate and partner with Clinical Operations colleagues to report metrics, findings, and trends.
- Participate in the review of clinical protocols and clinical source data to ensure compliant execution of clinical studies.
- Establish GCP system/process training needs, develop appropriate training materials and deliver and document training compliance.
- Support CQA system and process improvement initiatives; assist in developing appropriate tools and standard operating procedures to further enhance CQA activities.
- Maintain required knowledge of applicable regulations, guidelines and company standards and procedures.
- Contribute to continuous process improvement within clinical development by providing CQA recommendations and representation on project work-streams as required.
- Bachelor’s degree in a life science or related field.
- Minimum 8 – 10 years’ experience in the pharmaceutical industry.
- Minimum 5 years experience in Clinical Operations, Clinical QA and GCP auditing.
- Demonstrated understanding through prior experience of GCP regulations and knowledge of international and national regulations and guidelines related to the conduct of clinical research.
- Excellent communication and interpersonal skills to build key networks and business relationships across all levels of the business.
- Proven experience in working with clinical trial teams; working in a multidisciplinary environment.
- Ability to analyze complex issues, problem solve and take appropriate decisions and actions.
- Excellent computer skills (MS office, Word, Excel, Visio).
EEO & Employment Eligibility
TP Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. TP Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. TP Therapeutics is an E-Verify employer.
To apply, please submit your resume to email@example.com