Project Manager - Continuous Improvement Specialist

RESPONSIBILITIES

- Provides Project Management and Continuous Improvement (CI) expertise (eg DFSS, Lean, Six Sigma) and aids in embedding a CI culture within Development Operations.
- Leads the global development (and implementation as appropriate) of large-impact continuous improvement business process improvements.
- Provides project management oversight and expertise to partner with business lines to drive the development (and implementation as appropriate) of the business process improvements by employing project management, consultancy, change management, continuous improvement, implementation, influencing, and communication methodologies.
- Drives implementation of Data Quality Framework activities, specifically Quality Gates
- Teams with a group of subject matter experts to enable Development Operations to create and sustain a culture of continuous improvement and innovation.
- Provides the tools to successfully execute PM/CI initiatives as prioritized.
- Shares knowledge/coaches Dev Ops colleagues in application of methodologies on specific projects.
- Executes and leads groups to execute well-designed projects.
- Plans and manages the successful implementation of the project deliverables.
- Identifies and installs metrics to evaluate effectiveness of process improvements.
- Provides process/system design and optimization ideas.
- Partners with the Performance Analytics and Benchmarking group to provide business performance analysis support.
- Collaborates with the SOP and Training lines within to ensure appropriate SOPs and Training are in place for all new processes

SKILLS

Critical: Lean Six Sigma. Demonstrated knowledge of clinical research processes and regulatory requirements and the ability to gain command of process details is required. Expert knowledge of PM/CI practices/principles (eg Six Sigma, Lean, etc.) as applied within the pharmaceutical industry is a must. Must have the ability to effectively use a wide range of communication skills and proven skill in leading Matrix teams. Possesses effective prioritization, communication, and influencing skills. Capable of applying project management and communications skills as well as business process tools. Demonstrated ability to manage complex projects and cross-functional processes. Able to develop and implement tools/methodologies and improve/enhance process or business related practices. Strong understanding of the state-of-the-art technologies to evaluate and leverage them into improved business processes for deployment and adoption.
Training Six Sigma Master Black Belt preferred. Experience with Agile methodology desirable.
Training & Education Preferred: PMP certification. Master's level education in science, technical or business based discipline highly desired. Business degree and/or coursework with specific training in process methodologies and tools are desirable. Training in leadership skills, supervisory skills and change management skills a plus.

Prior Experience Required: Previous track record of success in project management in clinical trial execution or drug development background. Utilized Design for Six Sigma Methodologies in recent project work. Has implemented projects which influenced business or strategic outcomes. Experience using statistical software (SAS, Minitab, etc) and various SPC tools (ie, control charts, process and measurement capability, iNexus). Ability to build strong global and local networks across functions, lines and zones. Strong interpersonal skills with a demonstrated ability to interact and influence with many levels of technical and business staff. Excellent analytical and organizational skills are required. The candidate must also possess very good communication skills (both written and verbal). BS and over 10 years of experience OR MS and over 5 years of experience.
Prior Experience Preferred: Experience working in a global and multicultural organizations working across national and international boundaries. Has developed and led projects which influenced business or strategic outcomes. Hands-on managerial/leadership experience. Thrives in product development and/or fast-paced complex operating environment. A strong working knowledge and understanding of drug development processes, database structures, relational database management software, and analysis tools.
Must have advanced skills (7+ years of experience) in MS Excel, MS Outlook, and MS Word.

Synectics is an Equal Opportunity Employer.