Kura Oncology, Inc.

Sr Mgr/Associate Director, GMP Quality Assurance Boston, San Diego, Remote (Boston)

REMOTEPosted a month ago

Job summary

  • Job post source

    This job is directly from Kura Oncology, Inc.

  • Job overview

    The Sr Mgr/Associate Director, GMP Quality Assurance at Kura Oncology leads GMP quality oversight to ensure compliance and quality in drug manufacturing processes, impacting cancer treatment development.

  • Responsibilities and impact

    The role involves managing day-to-day GMP quality activities, overseeing external vendors, reviewing GMP documentation and batch records, supporting quality agreements, generating quality metrics, leading compliance for regulatory inspections, and collaborating cross-functionally to maintain and improve quality systems.

  • Compensation and benefits

    The position offers a base salary range of $125,000 - $161,089 for Senior Manager and $161,650 - $192,933 for Associate Director, with additional benefits including bonuses, 401K with employer contributions, stock options, ESPP plan, paid leave, stipends, and a comprehensive benefits package.

  • Experience and skills

    Candidates must have a BS/MS in a scientific discipline and 8+ years (Senior Manager) or 10+ years (Associate Director) of GMP/CMC QA experience in pharmaceutical manufacturing, with vendor oversight and knowledge of US, EU, and ICH regulations; strong communication, leadership, and software proficiency are required.

  • Career development

    The job offers opportunities to work in a leading biotech company with a strong culture and patient-focused mindset, enabling growth through collaboration, leadership in quality assurance, and involvement in innovative cancer drug development.

  • Work environment and culture

    Kura Oncology fosters a diverse, science-driven, and patient-focused culture emphasizing integrity, excellence, innovation, and teamwork, with regular social activities and support for work-life balance.

  • Company information

    Kura Oncology is a clinical-stage biopharmaceutical company focused on personalized cancer therapeutics, with a pipeline including investigational drugs targeting blood cancers and solid tumors, and offices in San Diego and Boston.

  • Team overview

    The candidate will report to the Sr. Director of GMP Quality Assurance and work closely with the CMC department and external vendors, participating in GMP sub-teams as the Quality Representative.

  • Job location and travel

    The position is based in Boston, San Diego, or remote, with periodic international travel to company offices and vendors required.

  • Application process

    Applicants must submit personal and educational information, resume/CV, and respond to various questions about relocation, sponsorship, salary expectations, and motivation for applying through Kura Oncology's application portal.

  • Unique job features

    This role is distinguished by its leadership in GMP quality assurance within a cutting-edge biotech company focused on precision oncology, offering involvement in regulatory filings, health authority inspections, and continuous quality system improvements.

Company overview

Kura Oncology, Inc. is a biopharmaceutical company focused on the discovery and development of precision medicines for the treatment of cancer. They generate revenue primarily through the development and commercialization of targeted therapies, including their lead product candidates tipifarnib, KO-539, and KO-2806, which are designed to inhibit specific cancer-causing genes. Founded in 2014, Kura has made significant strides in oncology research, including advancing multiple clinical trials and securing strategic collaborations to enhance their drug development pipeline.

How to land this job

  • Position your resume to emphasize your extensive experience in GMP Quality Assurance, especially your leadership in managing vendor oversight, batch record review, and regulatory compliance aligned with US, EU, and ICH guidelines.

  • Highlight your track record in collaborating cross-functionally with CMC teams and external vendors, showcasing your ability to drive quality improvements and support regulatory filings and inspections.

  • Apply through multiple channels, including Kura Oncology's corporate career site and LinkedIn, to maximize your visibility and ensure your application reaches the right hiring managers.

  • Connect on LinkedIn with current employees in Kura Oncology's Quality Assurance and CMC divisions, using ice breakers such as commenting on recent company achievements in precision oncology or asking about the team culture and expectations for the role.

  • Optimize your resume for ATS by incorporating keywords from the job description like 'GMP Quality Assurance,' 'vendor oversight,' 'batch record review,' 'CMC,' 'regulatory compliance,' and specific software names like 'Veeva Quality-Docs' to pass automated screenings effectively.

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