ESSENTIAL JOB FUNCTIONS:- Leads the Quality Unit responsible for Good Clinical Practices (GCP), Good Laboratory Practices (GLP), Good Manufacturing Practices (cGMP), Good Pharmacovigilance Practices (GVP), and Computer Software Validation (CSV).
- Develops, implements, and manages the Quality System to the standards expected by Health Authorities to support clinical development, commercial operations, and the post-approval product lifecycle.
- Commercial product disposition and end-to-end quality oversight of manufacturing, testing, packaging, labeling, storage, and distribution activities.
- Governance and quality oversight of the commercial supplier network, including CMOs, contract laboratories, packagers, distributors, 3PLs, and applicable specialty-pharmacy partners.
- Oversight of the commercial product quality lifecycle, including product complaints, investigations, returns, field alert reports, recalls, market actions, and counterfeit or product-integrity concerns.
- Provides Quality oversight for internal GCP, GMP, GLP, and GVP activities.
- Ensures appropriate Quality oversight of CMOs, laboratories, suppliers, packagers, distributors, 3PLs, and alliance partners
- Leads Inspection Readiness and/or Inspection Preparedness efforts.
- Acts as lead/Host contact for GxP site inspections.
- Manages Quality System Reviews and presents to Management.
- Evaluates GxP activities for continuous improvement opportunities to the Quality System.
- Ensures risk-based quality management (RBQM) is applied as appropriate to clinical studies.
- Manages critical GxP product-quality, data-integrity, safety, and compliance events
- Identifies potential Quality risks to strategic and/or operational plans and proposes options to mitigate risks.
- Manages GxP Quality personnel, activities, and budget.
JOB SPECIFICATIONS:- Bachelor's degree in a Life Sciences discipline or equivalent.
- A minimum of 18 years of relevant experience in a regulated biotech, or pharmaceutical industry in a Quality Assurance function.
- Clinical development, commercial launch, and marketed-product lifecycle experience with strong experience supporting NDA approvals, MAAs, commercial launches, and post-approval submissions
- Experience with developing, implementing, and maintaining GxP Quality System which ensures compliance to GxP and regulatory standards.
- Experience in managing, hosting and/or supporting Health Authority inspections.
- Demonstrates proven track record of leadership, communication, and motivation skills with internal and external Vendors.
- A strong team player with the ability to effectively communicate sound quality advice cross-functionally based on experience, regulations, and business needs.
- Provide solutions to issues. Solutions are imaginative, thorough, practical, and consistent with objectives.
- Solves conflict and addresses workplace issues in professional and collaborative manner.
- Flexibility and ability to provide a solution-based approach to emerging challenges and changing priorities.
- Clear, concise writing skills and good verbal presentation skills.
- Self-motivated, detail oriented, well organized, and able to demonstrate success with managing multiple projects simultaneously and other priorities.
- Ability to interact constructively and efficiently with co-workers within and across departments, Management, and Vendors.
- Owns and makes final decisions for the function, including those with significant impact on portfolio strategy, organizational priorities, and business outcomes.
- Leads cross-functional alignment at the executive level, partnering with senior leaders to drive integrated strategy and ensure execution against enterprise priorities.
- Communicate decisions and recommendations with clear justification.
- Ability to resolve day-to-day issues efficiently while maintaining compliance.
- Independently determines and develops approach to solutions.
- Proficient in Veeva QualityDocs.
- Proficient in Word, Excel, PowerPoint, SharePoint.
- Ability to travel for both domestic and international business.
The base range for a Vice President is $325,000 - $372,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training. Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus.
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Kura's Values that are used for candidate selection and performance assessments:- We work as one for patients
- We are goal-focused and deliver with excellence
- We are science-driven courageous innovators
- We strive to bring out the best in each other and ourselves
The Kura Package - 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!
