Note: The job is a remote job and is open to candidates in USA. Kura Oncology is a commercial-stage biopharmaceutical company focused on developing innovative precision medicines for cancer treatment. The Senior Manager, Clinical Quality Assurance (CQA) will oversee quality and compliance processes for clinical development programs, ensuring adherence to regulations and fostering a quality-focused culture across the organization.
Responsibilities
- Develop collaborative partnerships with clinical study teams to provide GCP compliance guidance and advice across assigned clinical programs
- Ensure compliance with clinical quality assurance activities including facilitating and supporting internal and external GCP audits/audit programs, as applicable
- Support QA activities that foster an outcome of compliance and adherence to relevant laws, regulations, guidance; upholds the rights and welfare of patients; is focused on data integrity and end to end quality assurance
- Assist in identifying opportunities for process improvement initiatives, including process/program reviews to identify approaches that will prevent quality issue recurrence (e.g. issue escalation and management; and applicable corrective/preventative action programs, periodic internal audit/gap assessment)
- Assist with the development and tracking of trending and metrics of internal as well as external vendor quality issues
- Support clinical inspection readiness activities for assigned programs and other key programs as applicable
- Support Regulatory Inspections of Kura Oncology products, including supporting/facilitating back room and front room activities and supporting the drafting/reviewing of responses to regulatory authority findings, as applicable
Skills
- BA/BS degree required, advanced degree a plus
- A minimum of 6-8 years of experience in the bio-pharmaceutical R&D industry with at least 3 or more years in a current, hands-on in a manager-level GCP Quality Assurance
- Demonstrated experience drafting, reviewing, implementing, and optimizing standard operating procedures (SOPs)
- Demonstrated knowledge and application of Global regulations and guidance for GCP (knowledge of GCLP and or GVP a plus)
- Direct experience in the conduct and reporting of internal and external audits, root cause analysis and the translation of findings into corrective actions plans that mitigate risks to study subjects, data integrity and clinical programs
- Experience preparing for, participating in, and subsequent response to health authority GCP/GVP inspections/partner audits
- Working knowledge of Veeva (or similar QMS e-system) required. Knowledge of Inspection Management Tools a plus
- Excellent oral and written communication
- Ability to manage multiple projects and demanding timelines
- Operational Experience (e.g., Clinical Operations, Data Management), work in both clinical and commercial stage organizations; and/or experience as a trainer are an advantage
- Exercises independent judgement in managing operational decisions within their area; proactively identifies issues and determines when to escalate more complex or cross functional decisions
- Serves as a key point of contact for cross-functional partners within their area; ensuring alignment and proactively addressing coordination needs to support team deliverables
Benefits
- Generous benefits
- Equity
- Participation in an annual target bonus
- Career advancement/ development opportunities
- Competitive comp package
- Bonus
- 401K + Employer contributions
- Generous stock options
- ESPP Plan
- 20 days of PTO to start
- 18 Holidays (Including Summer & Winter Break)
- Generous Benefits Package with a variety of plans available with a substantial employer match
- Paid Paternity/Maternity Leave
- In-Office Catered lunches
- Home Office Setup
- Lifestyle Spending Stipend
- Commuter Stipend (Boston Office)
- Regular employee social activities, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and much more!
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