The focus of Hillsboro Technical Operations (HTO) is Drug Product manufacturing (Component Prep & Compounding, Liquid/Lyophilized Filling, Automated/Manual Inspection, Packaging/Finished Products and Distribution.)
Main Purpose of the Position/Description:
The Filling PUL role is a people leadership position, which serves the specialized technical staff responsible for aseptic filling operations and filled product inspection operations. It is a leadership position that requires both shift work and work across multiple shifts, which supports the Value Stream organization as a member of the Value Stream Leadership Team (VSLT). In this capacity, this role supports strategy realization, development and coaching of people across the Value Stream and supporting teams in development of tangible actions to realize business results. The position organizes and prioritizes critical issues and required information for the technical team to facilitate end to end thinking and efficient decision making necessary to meet customer needs, in partnership with all Value Stream personnel.
Create an environment of strong team spirit, timely and effective communications, sense of urgency, high motivation and inspire teams to achieve goals in the immediate and longer term.
Lead and implement Value Stream initiatives and ensure all systems operate smoothly and align with our safety and quality standards
Maximize the efficiencies of all business procedures and systems and support the VSLT in the establishment of Value Stream KPIs and conduct quality and performance assessments
Ensure manufacturing of quality products according to Health Authority and Roche Pharmaceutical Quality System requirements, including Discrepancy Management System, CAPA systems, Quality Risk Management and Technical Change Management.
Monitor end to end operations and address potential issues when they arise
Build processes that meet our business objectives and ensure compliance
Monitor financial data and recommend solutions that will improve profitability
Incorporate innovative and strategic initiatives
Serve as a coach and catalyst to coordinate and oversee problem solving efforts on manufacturing related failures and implementation of identified corrective actions.
Partner with Talent Acquisition on staffing related initiatives for the Commercial Value Stream
Ensure the facility is always regulatory inspection-ready through observation, coaching, teaching and upskilling of value stream staff. Foster quality mindset and a culture of compliance with quality system and regulatory requirements.
Inspire and coach team members, in partnership with the VSLT executing strategy to achieve goals that support our journey to reach the PTG Mileposts and Pharma Ambition.
Support, coach and teach team members in development activities that foster a deep understanding and consistent use of lean and agile ways of working, which result in waste reduction and a strong sense of ownership.
Organize and prioritize critical issues and required information for the technical staff to facilitate strategic decisions and support teams in taking empowerment to realize timely and efficient decision making, with the greatest extent of autonomy as possible
Manage team member performance, utilizing Roche’s People Practices and all development and performance management tools and processes available to create the most positive employee experience possible.
Strong creative leadership skills according to Visionary, Architect, Coach, and Catalyst (VACC) model and shown ability to build a forward-thinking outlook; remove barriers, develop people and technical capabilities; build an environment which enables people to perform at their best
Behaviors demonstrate Roche’s mission of advancing and boldly championing diversity, equity, and inclusion.
Strong ability to implement, coach, and apply lean and agile ways of working
Partner with leadership team to develop the organizational strategies, which ensure the GMP compliance of the site, continuous improvements, and achievement of long-term goals.
Lead, coach, and guide teams and groups. Manage performance and development of the members of the Value Stream/Support group to achieve organizational goals and employee personal and professional growth
Have a strong understanding and engagement of people practices including hiring, promotion, compensation, mentoring, and coaching, and apply these in order to shape the site culture.
Provide training of personnel on company and department policies systems and processes by understanding the end-to-end view
Be a champion and advocate for Engrained Quality at the Site
Lead efforts to build a culture of continuous improvement and model lean leadership principles
Strong servant leadership presence and resonant communication at all levels. Experience framing communications for all audiences.
Experienced organizational leadership: Proven ability to lead and align an organization with diverse disciplines; experience developing/realizing a vision and multi-year strategies. Passion for developing talent and a culture of innovation, collaboration, and engagement. Demonstrated ability to lead transformation and effectively engage stakeholders.
Strategic consulting skills: deeply listens and responds with agility. Navigates complex organizational and business dynamics, including the ability to influence and partner with the Value Stream Lead.
Strategic and systems thinker who proactively anticipates business risks and has a strong drive for execution. Balances need to create an exceptional workforce experience with the need to deliver operational efficiency.
Ability to navigate and influence the site culture, including new ways of working. Demonstrated experience and success with building networks and collaborating with key clients and partnering functions.
Understand right to operate, governance, sustainability, and best practices in communication and engagement.
Possess a strong network of thought partners who bring insights on best practices in business operations, strategy, and high-performance cultures.
BS with 8-11 years’ experience, 5-7 with Masters, 3-6 with PhD, plus 3-4 years people leaders experience
Advanced knowledge and subject matter expertise in cGMP biologics with an understanding of manufacturing processes, quality systems, and GMP regulations
Lean, Six Sigma, Agile, Quality by Design, Business Analytics and SAP experience preferred.
To apply for this job please visit careers.gene.com.