The incumbent works with internal stakeholders to drive operational excellence within TOPS, as well as the assigned sub-function(s). The individual :
instills the OE philosophy and the culture of continuous improvement
drives performance by managing as well as supporting OE projects (e.g., business process building or redesign)
builds organization-wide OE proficiency via creating / providing infrastructure (e.g., training, communications, certification programs).
The role focuses on building efficient, scalable processes and improving current processes, eliminating redundancies, improving information flow and integration to increase productivity, transparency, and quality.
The position contributes to OE knowledge, performs analysis, develops solutions, lead / assists with project implementation, provides training, and measures and delivers results.
The incumbent defines and tracks operational metrics and goals and holds self and teams accountable for completion.
Principal Responsibilities :
Serves as the primary contact and subject matter expert for continuous improvement activities within the sub-function, interfacing and liaising with impacted Seagen groups
Serves as an advocate for OE while maintaining good relationships with cross functional teams and responsible for escalation of problems, disputes, questions, and improvement opportunities
Working with sub-function staff, assess current business processes and identify opportunities for continuous improvement to drive efficiency, scalability, and risk reduction
Support business case preparation to take the OE ideas to initiatives through approval & investment processes
Manage and lead cross-functional or sub-functional project teams focused on process building and / or improvements
Develop, use, and maintain tools and techniques supporting Operational Excellence activities.
Train OE ambassadors with the execution of tools e.g. stakeholder mapping, value stream mapping, process optimization
Gather and translate sub-function user needs into user requirements for system implementations / upgrades and resulting business processes
Implement solutions and develop tools to enable consistent, efficient, and compliant operations
Anticipate operational challenges based on long range business objectives and initiate planning to implement solutions in preparation for the future state, including intermediate solutions as necessary
Influence cross-functional teams to meet compliance and business needs
Develop and present training tools to staff to support a culture of OE and continuous improvement. Mentor staff to become certified continuous improvement practitioners.
Owner of the sub-function improvement project portfolio and responsible for tracking and follow-up of performance objectives
Role models good OE practices to others
Conducts trainings & events to build OE culture in TOPS
Required Qualifications :
At least 10-15 years of experience in Pharmaceutical Industry; with Process Development, Production or Quality unit experiences preferred
At least 5-8 years of OE experience (as a practitioner) in executing continuous improvement projects utilizing standard tools and methodology
Lean six sigma certification OR equivalent years of proven OE results and track record
Experience in working with regulated systems including software applications
Ability to clearly articulate problem statements, identify solutions and influence business partners to align on implementation and prioritization
Ability to work creatively within business and compliance constraints to provide solutions
Adept at identifying business needs and translating them to solutions
Experience implementing risk management in various business processes
Demonstrated knowledge and experience in the interpretation and application of cGMP and ICH requirements for both domestic and international territories
Has a bias for action and displays a sense of urgency
Must possess strong skills in leadership, motivation, mentorship and negotiation
Able to make difficult decisions in a logical, rational manner
Demonstrated ability to work as a senior team member and to engage and influence team members in a matrixed environment
Ability to work well in both internal and external teams, including experience in virtual teams
Excellent communicator both verbally and in writing with all levels of staff, both inside and outside of the organization
Ability to work in a fast-paced environment
Ability to prioritize work and handle multiple assignments, while maintaining a high level of quality
Ability to travel 10-15% of time
Bachelor’s or Master’s degree in scientific discipline or equivalent with relevant industry experience in a cGMP regulated environment such as Manufacturing or Quality
As a leading employer in our industry, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families.