R&D Operations Project Manager
Country : USA
State : New York
County : Suffolk County
Town : Melville
Category : Production - Quality
Contract type : Permanent
Availability : Full time
The geographic scope is Global and includes all R&D Laboratories at Melville (USA), Blaine (USA), Shanghai (China), Toronto (Canada), Paris (France), Seoul (South Korea) and Tokyo (Japan).
- Lead project planning and management of R&D Operations projects.
- Responsible for the portfolio and project plans - project documentation and status reporting.
- Lead project meetings and provide updates to stakeholders
- Effectively applies ELC/ITPMO methodology and enforces project standards
- Manages project budget tracking including updated forecast on a monthly basis.
- Tracks key project milestones and manages project plans to meet the project objectives.
- Ensure all programs and projects are delivered comprehensively, completely, on time, and within budget.
- Manage project risk exposure and will escalate functional, quality, timeline issues appropriately.
- Accountable for the overall cross functional project performance including coordination of the integration of project activities and project resources, and mitigation and management of execution risks.
- Provides oversight and leadership to other Project Managers in portfolio and resource planning, assigning projects, and providing support to direct report project managers.
- Serves as a liaison between IT and Business Teams to ensure proper escalation for scope changes, issue and risks
- Collaborating with Corporate functions - Global Supply Chain, Global QA and IT - to ensure SOP and Work Instruction standards are aligned cross functionally.
- Provide management updates (monthly/quarterly) at Global and Site level to ensure visibility of project priorities and risks.
- Ensures adherence to FDA Validation, CFR 21 Part 11 and Change Control management processes requiring a detail knowledge of the R&D Quality Systems inclusive of Change Control , CAPAs and Deviation procedures.
- Experience collaborating with Vendor Management Offices (VMOs), Indirect Procurement Teams, and Program Management Offices (PMOs) to launch new initiatives, create Statement of Works (SOWs)
- SDLC Methodology - Agile / Scrum / Iterative Development/ Waterfall/ Rapid Development
- Knowledge of budgeting and work scheduling tools and techniques
- Experience with business process improvements/enhancements management and implementation
- Superior communication skills for strong stakeholder engagement for consensus building.
- Knowledge of GXP (Good Clinical/Manufacturing/Documentation practices)
- Experience in Electronic Document Management Systems (e.g. OpenText) preferred Knowledge of FDA Validation and CFR 21 Part 11
College Graduate - BS
10 Years Experience
We are an equal opportunity employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply. It is Company's policy not to discriminate against any employee or applicant for employment on the basis of race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. The Company will endeavor to provide a reasonable accommodation consistent with the law to otherwise qualified employees and prospective employees with a disability and to employees and prospective employees with needs related to their religious observance or practices. Should you wish to apply for this position or any other position with the Company and you believe you require assistance to complete an application or participate in an interview, please contact USApplicantAccommodations@Estee.com.