Project Manager- Operational Excellence

Project Manager OEM "Operational Excellence Manager" Job Summary: The Project Manager is responsible to lead multiple small to large projects through the project lifecycle completion and to support the strategic initiatives of the Operational Excellence Department through timely implementation of projects.
Essential Job Duties:

Develop and manage project schedules to track key milestones and project completion
Track a project through all phase gates of project initiation, planning, implementation, and closure
Manage resource allocation and project prioritization of key projects
Generate Risk Mitigation Plans and Risk Register for medium to large projects to ensure successful project completion
Generate Project Plans for large projects to summarize project scope, qualification strategy, submission strategy and timeline.
Lead and manage medium to large plant projects that impact capacity expansion, reliability, process improvement, and quality/compliance.
Generate Risk Assessments for implementation of projects prior to closure of change control
Coordinate on-time project implementation with supporting groups such as Manufacturing, Quality Assurance, Facilities, Maintenance, Validation, Quality Control, Quality Operations, and Materials Management.
Coordinate change control approval and implementation of projects;track projects through change control to closure
Be curious to ask probing questions to ensure team's understanding of project objectives and requirements, facilitate discussions to clarify roles & responsibilities, and alignment on timelines
Expertly utilize soft skills like leadership, communication, critical thinking and emotional intelligence to ensure team engagement and collaboration
Successfully identify and remove road blocks that prevent meeting the project schedule.
Identify when escalation is required to higher-level management to mitigate critical project delays.
Support Associate Director of Project Management with project tasks as requested
Support development and standardization of PMO governance, process, and templates
Job Requirements:

Bachelor of Science degree in Engineering, Biology, Chemistry, Biochemistry or closely related scientific/technical discipline is required.
PMP Training and Certification desired.
Minimum 5 years experience in pharmaceutical industry including 3 years in increasingly complex project management duties in a GMP operations environment.
Requires understanding of principles and qualification requirements for a range of systems and equipment, including ultrafiltration, CIP, chromatography, reactor tanks, centrifuges, filter presses, etc.
Knowledge of cGMPs, FDA regulations, and industry guidelines.
Strong technical writing skills.
Ability to inspire high performance in others and align team.
Ability to lead, motivate, guide, train, coach and develop personnel.
Demonstrated project management skills.
Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions.
Must be proactive, results oriented, and have strong attention to detail.
Self-starter with strong work ethic and the ability to exercise good judgment.
Ability to effectively prioritize multiple tasks to meet deadlines.
Strong interpersonal skills with the ability to interact with personnel at all levels in a team.
Drives departmental projects to completion through providing leadership and management to all personnel and functions involved.
Management of projects to meet appointed timelines and achievement of required completion dates.
Identification of project scopes, required resources, resource assignment and management.
Responsible for communication and coordination with other departments to streamline the transition of projects to routine manufacturing.
Provide leadership for ongoing Validation projects.
Participates in departmental meetings and cross functional team meetings as required.
Assembles cross-functional teams and/or facilitates team meetings as necessary.
Provide scientific and/or technical advice and counsel regarding projects as needed.
Strict adherence to procedures and practices according to FDA regulations.
Strong emphasis on documentation according to FDA regulations.
Adhere to departmental corporate safety policies.
Must be flexible with working hours in order to accommodate the 24 hour, 7 day plant operation.
Occupational Demands:

Work is performed in an office environment with exposure to electrical office equipment.
Frequently sits for 6-8 hours per day.
Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists.
Occasionally walks and stands.
Occasionally bends and twists neck.
Light to moderate lifting and carrying objects with a maximum lift of 25lbs.
Frequently drives to site locations with occasional travel within the United States.
Able to communicate information and ideas so others will understand;with the ability to listen to and understand information and ideas presented through spoken and written words and sentences.
Interacts with others, relates sensitive information to diverse groups.
Must work with diverse groups to obtain consensus on issues

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