Director/Sr. Director Quality Systems and Compliance

Type: Full-time, permanent

Location: Waltham, MA or remote

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The Company:

We have partnered with a fast-growing cell and gene therapy biotech, developing a next generation acceleration model for cell therapy, gene therapy and viral vector drug products. Our client is disrupting the way that these innovative therapies are developed and manufactured and is in a high growth phase across the organization. The Quality team has grown from 3 to 8 people over the past year and is continuing to grow. This company has an exciting pipeline of portfolio products and partners and has just announced their Series C funding, which makes this a great time to join and another positive step forward for this innovative company.

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The role:

We are seeking a highly qualified Director/Sr. Director, Regulatory Strategy to lead the development and implementation of Quality Management Systems in our headquarters GMP facility and for future sites. Reporting to the VP of Quality Assurance, this is an exciting opportunity for a highly skilled Quality and Compliance leader to join an exceptional team to develop a strategic, long-term vision for the Quality Management System, Training and Documentation across one state of the art GMP site with the potential to oversee additional sites in the future.

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Responsibilities:

• Strategic planning of the QMS including short and long-range quality plans and objectives related to the QMS

• Interacting effectively with company management, internal departments and other sites to implement and maintain the QMS

• Developing and conducting the GxP training programs, inspection readiness programs, as well as internal and external audits

• Guiding and lead cross functional teams to implement the quality strategies with respect to the collection, documentation, analysis, problem solving, and reporting of quality data and key Quality Indicators to drive corrective and preventive actions

• Creating, facilitating, and managing required QMS meetings including Review Boards and Quality Management Review

• Developing raw material/supplier management program by further defining and measuring entire lifecycle

• Promoting Quality and GxP awareness across the organization including training initiatives

• Identifying and implementing continuous improvement projects related to the QMS and compliance

• Providing strategies to address compliance gaps or determines enhancements to cross-functional quality systems

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Required qualifications:

• Bachelor's degree in a life science or related discipline required; higher degree preferred

• 12+ years’ experience in the biopharmaceutical industry

• 5+ years direct experience in leading, overseeing, implementing or supporting Quality Management Systems

• Expert knowledge in worldwide regulations and the ability to interpret and implement these requirements

• Experience in regulatory inspections

• Ability to think strategically and to influence others

• Ability to identify, prioritize, and implement actions to continuously improve operations and systems and manage risks

• Appreciation and desire to operate within a completely digital environment.

• "Roll up your sleeves" attitude with energy and initiative

• Excellent communication and cross functional collaboration skills

• Hands-on leadership ability and desire to motivate and drive teams to success

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Salary: On application