Project Manager – Quality & Regulatory Affairs

Job Description

• This position will lead or support a variety of large to medium size projects within Quality and Regulatory Affairs function.
• Leads projects and working teams to effectively initiate, plan, execute, monitor, and close projects
• Leads projects
• Leads projects through issues, roadblocks, and problems
• Acts as a change agent to drive teams toward success
• Guides team members to perform through issues and constraints
• Owns projects
• Owns the timeline, budget, resource constraints, and deliverables/results
• Shifts between the "big picture" and the small-but-crucial details
• Is prepared to roll up their sleeves and work through detailed issues
• Manages projects
• Ensures all appropriate tools are completed and used effectively (e.g., charter, Gantt chart, status updates)
• Communicates
• Actively communicates with project sponsors and stakeholders
• Establishes regular points of communication
• Manages sponsor and stakeholders expectations
• Delivers the expected results
• Performs root cause analysis on project shortfalls and takes corrective action as necessary
• Applies project management tools and techniques toward a variety of large, and likely inter-related, projects
• Establishes and leads programs comprised of multiple projects, including designing how information is rolled up and cascaded down, operating rhythms and mechanisms, and tracking against the integrated set of milestones and deliverables
• Documents business processes
• Up to 25% Travel, Domestically
• Shift/Time Zone: 8-5 M-F Hybrid role
  
  

Job Qualifications

• Bachelors Degree - required
• Experience in Quality and Regulatory affairs, especially within a Lab or Pharma setting is preferred
• Formal training in project management or continuous improvement methodologies (e.g., Six Sigma, Total Quality Management, Lean, Theory of Constraints)
• PMI Project Management Professional (PMP) - required
• Demonstrated experience leading large or complex projects with multiple workstreams from initiation to completion (7-10 years experience)
• Demonstrated experience facilitating discussions or workshops
• Demonstrated ability to develop strong relationships with others
• Demonstrated experience leading changes
• Demonstrated ability to influence business leaders
• Some experience with process management
• Basic knowledge of VOC tools
• General knowledge of Hoshin and breakthrough planning
• Skills:
• Demonstrated data analysis skills
• Problem solving skills
• Effective written and verbal communication skills across multiple formats: formal presentations, meetings, conference calls, e-mails, and memos
• Microsoft Word, Excel, PowerPoint, and Project
• SmartSheet
• Interpersonal skills
• Decision making skills
• Planning and organization skills
• Negotiation skills
• Results-oriented
• Creative
• Persistent
• Composed
• Able to learn new concepts rapidly
• Able to work independently with little supervision
  

Benefits

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.

Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

Synectics is an equal opportunity employer.