Project Manager Medical Devices Product Development
1 week ago
Drives project to successful completion through best practices and stakeholder management. Indirectly manages resources and may directly manage resources
Essential Duties and Responsibilities:
Leads large team/teams in defining program strategies and developing goals/milestones.
Drives and tracks a portfolio of projects, ensuring project owners have appropriate schedule, scope and budget controls in place and successfully deliver against milestones.
Provides program updates and conducts reviews with all levels of management.
Using project management tools, develops mechanisms for monitoring project progress and for intervention and problem solving with line managers and other manufacturing leaders.
Approves team deliverables for project completion.
Anticipates and resolves conflict situations to a win–win outcome.
Escalates risks and issues to leadership and to key stakeholders for resolution.
May recommend Core Team members and assemble project Core Teams.
May interview, hire, coach, motivate, develop, recognize and manage performance of direct reports.
Role Specific Duties and Responsibilities:
Manage Geo Expansion and New Product introductions. Liaison to Corporate Pharma PMO and RLDD primary project representative.
Work with Manufacturing to closely manage product runs associated with new products includes engineering batches, stability batches, first of code batches.
Potentially manage make versus buy analysis working with client Manufacturing Strategy for the Port Molding facility in RLDD. Manage outsourcing activities with Supplier Quality if applicable.
Manage Clindamycin VIP project to add/qualify a new vendor for this API.
Work with PMO Sr. Manager and client Women Leaders organization to introduce a Financial Acumen course for the RLDD facility (specific to candidate).
Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Excellent interpersonal and leadership skills with ability to interface well with other departments and lead effectively and efficiently in a matrixed, team environment.
Must be well versed in Project Management tools (PMBOK or equivalent) and must possess knowledge of related disciplines.
Must have knowledge of such principles as GMPs, FDA guidelines and purchasing practices.
Must be capable of analyzing and solving complex problems through innovative thought and experience.
Must demonstrate strategic leadership, strong business acumen, and proficient supervisory skills, if applicable.
Must demonstrate ability to communicate effectively using a wide variety of skills and vehicles.
Ability to manage multiple cross–functional teams simultaneously.
Ability to design and implement projects/studies outside area of expertise.
PMP (project Management Professional) Certification is preferred.
Bachelor's degree or equivalent experience.
Additional Details Does the position allow for the worker to be virtual/remote? : No Shore Options Available for this Position : Onshore Only Direct or Indirect : Indirect Shift : USA–1
About us: DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid–West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.
DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.
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