Technology Transfer Specialist

Infotree Global Solutions; Thousand Oaks (CA); On-site; USD 140,000 - 170,000; Full time

Job summary

Infotree Global Solutions is seeking an NPI Lead to manage cross-functional NPI projects, ensuring scope, schedule, risks, and milestones are met through influence across teams.

The role requires driving GDP documentation in the quality system, maintaining Right-First-Time records, coordinating with Quality and Regulatory, and presenting updates to senior leadership while maintaining GMP standards and lifecycle management strategies.

Qualifications

• Experience with GMP/regulatory procedures and Right-First-Time initiatives.
• Ability to own Change Controls in Trackwise and ensure complete records.
• Strong writing and communication for cross-functional and leadership audiences.
• Proven ability to drive cross-functional meetings and problem solving.
• Experience in regulated environments (cGMP) and lifecycle management.

Responsibilities

• Lead cross-functional team meetings and own GDP documents in QMS.
• Ensure NPI projects meet schedule, scope and milestones with quality first.
• Collaborate with Quality and Regulatory to ensure compliance across the network.
• Report metrics and present to management; drive continuous improvement.

Skills

People management

Leadership

Quality systems

Job description

The NPI Lead will be primarily responsible for:

• Working with NPI support groups to develop, maintain, and implement the NPI project plan(s), being accountable for NPI scope, schedule, risk management, and leading matrixed teams through influence to meet NPI project milestones.
• Resolving issues in a timely manner and elevating cross-functional customer concern to various levels of management as appropriate.
• Owning Change Controls in Trackwise, ensuring records are comprehensive and compliant per GMP regulatory procedures. This must occur through a Right-First-Time approach.
• Proactively leading cross-functional team meetings, to ensure NPI project(s) and other relevant business cases execute per schedule.
• Succinctly communicating verbally, in writing, and through presentations to peers and senior leadership team.

Day-to-Day Responsibilities:

• Lead cross functional team meetings, be able to listen to problem statements and ask questions to understand root causes & next steps. Own GDP documents in the quality management system and operate with a right first time, quality first approach.

Additional Responsibilities include:

• Engaging with Quality and Regulatory teams to ensure alignment and compliance across the network and with various agency submissions while delivering NPI project(s).
• Holding supporting functions accountable for delivery of NPI project tasks through documentation of Lessons Learned and presentation to management when appropriate.
• Reviewing protocols for manufacturing activities and partnering with Quality Assurance to ensure that GMP standards are maintained in line with current SOPs, batch record documentation, and licenses.
• Identifying improvement opportunities within the organization and taking proactive steps to build consensus to implement those opportunities.
• Performing purposeful presence Gemba walks in the manufacturing plant to identify process improvement opportunities as pertaining to NPIs and relevant lifecycle management strategies.
• Reporting on team and plant metrics to ensure visibility to team operations and deliverables.
• Representing the team at plant-wide and network-wide forums, as needed.

Preferred Qualifications:

• Direct and/or indirect people management / leadership experience
• Drug Product Formulation and Vial/Syringe Filling operations
• Experience with various quality systems including change control, deviations, corrective and preventative actions, and/or validation practices
• Strong organization and technical writing skills; able to articulate complex problems concisely with technical and management staff
• Independent, self-motivated, able to multi-task in a fast-paced environment
• Team-player
• Demonstrated flexibility and ability to manage change
• Direct experience with regulated environments (e.g., cGMP etc.)

Top 3 Must-Have Skill Sets:

• Organized, cross-functional relationship builder
• Able to articulate and communicate problem statements clearly, with a quality-first mindset