Turning Point Therapeutics, Inc. (TP) is a clinical-stage structure-based oncology drug design company founded in October 2013 by Dr. J. Jean Cui, the lead inventor of cLdesign and development of novel chemical entities within oncology for established oncogene drivers with high incidence of secondary resistance mutations; newly identified disease-driven targets; and potential targets regulating the tumor microenvironment and tumor immunity. For more information, please visit us at www.tptherapeutics.com.
We are looking for an experienced Manager, Quality Assurance – GMP, who will take a leadership role in supporting CMC functions to ensure GMP compliance. The successful candidate will have career experience in one of the CMC disciplines and hands-on experience with building quality systems, performing CMO audits and participating in regulatory inspections. The manager will support the vision and drive the implementation of the quality systems required to ensure GMP compliance and inspection readiness. This position will report into the Senior Director, Quality Assurance.
- Work with and provide compliance guidance to Turning Point Analytical Development/Quality Control, Process Development and Formulations.
- Perform audits of Contract Manufacturing Organizations (CMOs), documents and internal systems and processes to ensure compliance with regulatory requirements and company policies and procedures.
- Prepare written audit reports and communicate findings and recommendations and evaluate the adequacy and completeness of corrective and preventative action plans.
- Review master and executed batch production records, including analytical data; address compliance issues and disposition product.
- Serve as Lead in resolving deviations and out-of-specifications to ensure timely disposition of product.
- Review and approve development and campaign reports.
- Review and approve Analytical methods, protocols and reports.
- Review and approve Stability protocols and reports.
- Support the development and delivery of GMP training.
- Support GMP system and process improvement initiatives; Contribute to continuous process improvement within Quality by providing recommendations and representation on project work-streams as required.
- Write and review standard operating procedures for Quality and CMC functions.
- Maintains required knowledge of applicable regulations, guidelines and company standards and procedures.
- University/College Degree in Scientific discipline/Life Sciences or related field.
- Minimum 6 – 8 years experience in the pharmaceutical industry.
- Experience in CMO and Laboratory auditing (minimum 3 years).
- Demonstrated understanding through prior experience of GMP regulations and knowledge of regulations and guidelines related to the conduct of good manufacturing practices.
- Excellent communication and interpersonal skills to build key networks and business relationships across all levels of the business.
- Proven experience in working with CMC teams; working in a multidisciplinary environment.
- Ability to analyze complex issues, problem solve and take appropriate decisions and actions.
- Excellent communication skills both written and verbal.
- Adaptable and a team player.
- Excellent computer skills (MS office: word; excel; Visio).
EEO & Employment Eligibility
Turning Point 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. Turning Point 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. Turning Point Therapeutics is an E-Verify employer.
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