Senior Manager, GDO Operational Excellence
Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer.
More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. Together, we are striving to outsmart cancer.
To learn more about us, please visit us at http://www.pharmacyclics.com/
General Position Summary/Purpose:
Under limited guidance of the Director and Sr Director of Operational Excellence, responsible for using process improvement methodologies and techniques to proactively analyze, identify, facilitate and manage continuous process improvement initiatives across Global Development Operations in collaboration and consultation with the business. This role will partner with other GDO functions both within as well as outside GDO to increase efficiency and compliance across the department.
Key Accountabilities / Core Job Responsibilities:
• Support the Global Development Operations Leadership Team in delivery of annual operational Process Improvement targets.
• Drives global, complex, cross-functional process and productivity improvement projects for Global Development Operations that support the organization's strategic objectives.
• Provides tactical input on the implementation of the strategic support for process improvement initiatives for GDO ensuring aligned execution.
• Work with key internal and cross-functional stakeholders to develop / deliver annual programs to optimize processes for increased productivity and quality.
• Establish and implement improvement methodologies and techniques, governance structure, project management structure and progress reporting.
• Develop and assess integrated project plans, resource projections, risk plans, and effectiveness metrics for each initiative.
• Help team navigate the change management process effectively and efficiently.
• Will matrix manage members participating in cross-functional process improvement initiatives to ensure projects are executed per timelines.
• Effectively communicate project progress/ concerns and actively identifies issues that potentially impact project completion and identify potential interventions or solutions to manage the issues.
• Is aware of both internal and external business environments, assesses impact on the process improvement initiatives and assists in making modification as necessary.
• Escalate significant issues to management and identify performance and resource gaps relative to process improvement initiatives, adoption of best practices, recommend corrective actions.
• Provide expertise in the solution to complex problems during project management execution (could include IT and/or business process solutions).
• Develop operational metrics to measure success and further assess and gather needs of already implemented process improvement initiatives.
• Provide metric reporting and presentations as needed to ensure alignment with business goals and objectives.
• Collaborate with GDO Training on education, training, and mentoring of GDO personnel, including trainings on Lean Six Sigma tools.
• Communicate proactively with internal cross-functional stakeholders and external vendors to ensure effective and efficient utilization of all resources.
• Build and maintain strong relationships across a matrix organization to meet organizational goals.
• Maintain current knowledge of, and ensure all work activities are conducted in compliance with the full range of related internal and external systems, technology, regulatory requirements and related policies and procedures.
• Coach and mentor junior GDO OpEx staff ensuring OpEx standards (e.g. DMAIC, Lean, Root Cause Analysis) are being used for problem solving (tools and methods) and daily continuous improvement.
• Act as a change agent to instill a continuous improvement culture throughout the organization.
Qualifications / Requirements:
• BA/BS or equivalent degree in a scientific or business discipline or related healthcare field is required.
• 8+ years global development experience in a pharmaceutical, biotechnology, CRO and/or healthcare setting.
• Minimum 5 years' experience in a Lean/Six Sigma role preferably in bio/pharmaceutical, biotechnology or life science industry.
• 5+ Years of Project Management experience and proven supervision and management of contractors and contingent workforce.
• Lean Six Sigma Green / Black belt qualification or equivalent. PMP a plus.
• Expert knowledge of FDA and other global clinical trial regulations, as well as detailed knowledge of ICH and FDA GCP guidelines.
• Proficiency in PPM tools (MS Project, CA PPM, etc.) MS Word, Excel, PowerPoint and SharePoint.
• Expert organization and project management skills.
• Excellent interpersonal and communication skills (both written and oral).
• Ability to define business improvement strategy, and manage, drive, and execute projects from concept through implementation.
• Ability to act as a change agent to instill a lean six sigma atmosphere and a continuous improvement culture.
• Analytical skills and problem solving capabilities are critical.
• Ability to work on complex or multiple projects and exercise critical thinking with little to no supervision.
• Proven ability to effectively teach complex information across participants with experience and capabilities.
• Proven ability to establish productive relationships and partnerships across the organization to ensure alignments of goals and deliverables.
• Strong leadership skills, self-motivated, adaptable to a dynamic environment.
• Able to collaborate effectively with internal project teams and Pharmacyclics business partners.
• Ability to establish priorities, excellent sense of urgency and ability to collaborate (interpersonal, relationship management) with study teams, cross functional team members and external partners/vendors.
• Must be proficient in taking initiative, have a hands-on approach and must demonstrate strong cross-functional facilitation skills to continuously drive improvement.
• Ability to multitask and adapt to rapid change within a complex environment.
• Self-motivated, adaptable to a dynamic environment.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled