Job Description
Job Description
Position Summary
The Project Manager II is tasked with establishing, maintaining and enhancing the relationship between BSM and external clients. They interact with many different members of the client's team and internal teams to organize and execute plans that ensure mutual success. The Project Manager II has more than two years direct project management experience in drug product manufacturing or equivalent, and is familiar with BSM processes and quality requirements to drive completion of the project on time and with target quality. The Project Manager II is expected to manage projects with a great degree of independence and demonstrate good judgement on when to seek help on resolving timeline and quality issues.
Duties and Responsibilities
Manage project initiation and planning
- Document and manage project scope; Define and prioritize associated project tasks
- Establish project goals, requirements, and desired results
- Create, manage, and update project schedules and timeline using Microsoft Gantt or other softwares
- Define, manage, and update resources
- Work with management to Identify and assign duties, responsibilities, and scope of authority to project team personnel
- Manage a total of 5-6 external projects and 1-2 internal projects at a time
Manage project execution and delivery
- Establish schedules and project parameters to accomplish project goals
- Drive Manufacturing readiness internally and with clients to ensure on time delivery
- Identify, manage, and escalate project risks and issues with internal and external stakeholders
- Coordinate the work across multiple projects with other project staff from various functional departments
- Prepare, Gather and/or review status reports prepared by project personnel and modify as necessary such as project Joint Steering meetings.
- Track the execution process to ensure that project team adheres to reporting requirements
- Facilitate team meetings to discuss and review the work
- Act as focal point for project problem resolution and escalation
- Establish conditions for project closure and manage closure
- Meet Project Management Metrics as assigned and defined
Manage project quality delivery
- Maintain quality mindset in delivery of projects with patient in mind at all times.
- Ensure the quality provided and delivered meets that in the agreed plan
- Ensure that the team follows all formal and informal best practices in project management and other initiatives
- Coordinate disposition of Client materials upon completion per internal policies
Report and Communication
- Prepare project reports for management, clients or others
- Facilitate interactive sessions and deliver presentations as required
- Notify clients of opened Quality Events upon initiation and facilitate discussion as needed
Relationship management
- Establish and maintain positive customer relationships appropriately
- Manage customer expectations in delivery
- Manage or establish vendor relations, as appropriate
Other duties as assigned
- Other duties may be assigned under above categories of responsibilities.
Regulatory Responsibilities
- Exhibit a quality mindset and a willingness to develop
- Knowledge of FDA, 21 CFR 820, 21 CFR 210 and 211, and other regulatory agency requirements sufficient to apply to quality operations and compliance
Supervisory Responsibilities
- N/A
Experience
- Two plus (2+) years previous project management experience
- Experience in managing multiple projects simultaneously preferred
- Experience in working with 3rd-party delivery model and structure a plus
- Experience with process improvement certifications (CMMI) a plus
Education
- Bachelors’ Degree or equivalent work experience required
- PMP Certification a plus
Knowledge, Skills & Abilities
- Knowledge of project management methods and tools (focusing on MS Suite)
- Strong listening, and oral and written communications skills required
- Leadership and team building skills a must
- Problem-solving skills required
- Coordination skills a must
- Excellent oral and written communication skills required
- Self-starter orientation
- Conflict management experience a plus
- Ability to deal with change
Physical Requirements
- Ability to sit and/or stand for prolonged periods of time
- Able to lift up to 10lbs