Job Title: GxP Project Manager

OUR CLIENT

Our Client Company, develops, manufactures, and supplies high quality sterile injectables for healthcare providers, clinics, hospitals and veterinary practices across the United States and Canada. We have locations in New York, Ohio, and Pennsylvania and sales territories nationwide.

JOB DESCRIPTION:

Support all departments of the organization with regards to project planning and implementation by providing project management services where responsibilities include but are not limited to, scoping of project, resource requirements analysis, generate timelines and communicate with upper management to status of ongoing projects as required. Project manager role will support enterprise systems which are managed at both NY and OH facilities.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

· Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time.

* Responsible for all aspects of project management for Quality Assurance, Quality Control and Manufacturing.

* Possess a clear understanding of the QA, QC and manufacturing process in the pharmaceutical industry.

* Facilitate problem-solving and decision making with respect to project deliverables and meeting timelines.

* Monitor project budgets to provide updates to the Executive Management Team with needed.

* Provide input on project team member performance to aid the functional heads in employee performance evaluations.

* Partner with IT to gather infrastructure and architectural requirements pertaining to relevant projects.

* Manage all project and compliance related issuesassociated with their project.

* Fully understand business cases including all internal and external factors which may derail the project and alert senior management of any potential pitfalls.

* Communicate all pre-defined events to team members and other stakeholders according to communication plan. Monitor and communicate any changes in project scope, timeline and cost to all appropriate individuals.

* Review IT Infrastructure vendor operations and outsourcing arrangements and collaborate with major service providers of IT Infrastructure.

* Participate in the development and improvement of computerized systems to ensure quality and adherence to cGMPs.

* Support and maintain Quality programs, policies, processes, procedures and controls ensuring compliance with current Good Manufacturing Practices (cGMP) expectations and established agency

* Perform any other tasks/duties as assigned by management.

* We all must embrace the QUALITY culture.

QUALIFICATIONS AND REQUIREMENTS:

· Bachelor's Degree in Business or Science, MS or MBA preferred.

· 3 years project management experience in pharmaceutical environment.

· PMP Certification is preferred.

· Exceptional influencing and team development skills.

· Ability to resolve conflicts and disputes on regulatory compliance issues.

· Superior organizational skills, must be able to manage multiple projects with high priority.

· Effective communication skills, both verbal and written.

· Effective time management and interpersonal skills.

· Demonstrates good coping skills and analytical problem solving skills.

· Solid presentation skills.

· Proficient in Project Management Software.

· Experience with ARGUS a plus.

· Experience implementing Quality Management Systems is a plus.

PHYSICAL ENVIRONMENT AND PHYSICAL REQUIREMENTS:

* Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees.

* Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision.

* Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly

· We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.