Quality Assurance Project Manager

Description:

• Leads global projects and/or programs which support various strategic initiatives within the Quality System.
• Responsibilities include all aspects of end-to-end project and/or program management within specific area of expertise.
• Actively collaborates with manufacturing sites, external manufacturing, regulatory, supply chain, product quality, compliance, and other global functions in order to successfully deliver objectives.
• Provides regular updates and recommendations to senior leadership in order to drive an effective Quality System.
• Develops project timelines, deliverables, conducts research analysis, monitors project status, and provides expertise for global projects/programs supporting strategic global Quality initiatives
• Actively collaborates with cross-functional team to complete project milestones per established timeline.
• Leads meetings with cross-functional partners.
• Utilizes expertise within GxP to review various types of content, such as external regulations or governing documents, and provide recommendations.
• May create and manage project/program tasks within quality software system.
• Builds and maintains collaborative partnerships with cross-functional stakeholders at all levels of the organization to understand business needs and incorporate these into assigned project/program decisions.
• Manages end-to-end lifecycle of project/program, including driving team accountability, addressing project risks, driving effective decision making.
• Creates and continuously improves meaningful metrics to demonstrate effectiveness and performance of assigned project/program.
• Monitors changes in external regulations and project manages changes to internal processes accordingly.
• Effectively delivers project or program status updates and recommendations for future strategic initiatives to senior leadership

Qualifications:

• Bachelor's degree in Science/Engineering/Business Management or equivalent technical work experience
• 5+ years of relevant Quality experience in a GMP pharmaceutical, biologics, and/or medical device manufacturing environment
• Strong understanding of cGxPs, regulatory inspections, regulatory documents, global regulations, and standards
• Experience in Project Management and leading cross-functional project teams with technical professionals in a global and/or complex, matrixed organization
• Strong oral and written communication, interpersonal, time management, influence, and problem-solving skills
• Proficient in the use of standard software applications including Office 365

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.