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Quality Program Manager I - Remote
| Company | Be The Match |
| Address | , Minneapolis, 55413, Mn |
| Employment type | FULL_TIME |
| Salary | |
| Expires | 2023-07-14 |
| Posted at | 11 months ago |
Please apply online using a laptop or desktop computer.
The Quality Program Manager I will actively partner with Quality and Regulatory Affairs (QRA) leaders to execute QRA improvement programs through data and process analysis, project management, and initiative support.
In alignment with process stakeholders, elicits input, translates applicable quality and regulatory requirements, and leads the implementation of optimization programs through project and change management practices. The Quality Program Manager I follows an established methodology for analysis, optimization, and implementation of quality processes while effectively influencing QRA and cross-functional stakeholders in broader aspects of program management.
This position manages improvement programs within the department’s compliance and improvement lifecycle and utilizes company/industry-standard project management methodologies and tools. This includes the management of budget, forecast, communications, risk assessment, contingency planning and change controls and escalation of critical issues to the project sponsor(s) and organizational leaders as required. This is a remote position (US). #LI-Remote
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ACCOUNTABILITIES:
- Evaluates QRA processes to develop programs and define projects that improve compliance, eliminate waste, and create efficiencies.
- Works with stakeholders to plan complex project plans and timetables, lead execution, and oversee all aspects of projects assigned, including project cost management.
- Conducts quality and regulatory risk assessments, and analyses of impacts and cost-benefits to promote programs and justify changes.
- Collaborates with process owners to define metrics to monitor the impact of programs and initiatives and facilitate the accomplishment of strategic objectives and goals.
- Provides leadership to project resources in a manner that ensures timely delivery on commitments in support of broader program deliverables and management of project change.
- Develops evaluation and assessment tools to evaluate QRA programs and disseminate results to key stakeholders.
- Helps define and establish new methodologies, processes, and best practices around business analysis and continuous process improvements.
REQUIRED QUALIFICATIONS:
Knowledge of:
- Change Management and Project Management best practices in addressing quality improvement and regulatory compliance needs.
· Project cost analysis and management.
· Process mapping, business analysis, and process optimization techniques.
Ability to:
- Apply solid program and project management skills.
- Coach and mentor improvement project team members.
- Positively challenge ideas, requests, needs to ensure business value is delivered.
- Bring diplomacy and tact to difficult situations (i.e., influence and negotiation skills).
- Manage multiple assignments simultaneously, work and deliver under tight timeframes, and manage complex projects with multiple stakeholders.
- Demonstrate exceptional written and verbal communication skills, presentation and facilitation skills and the ability to communicate at all levels of the organization.
Education and/or Experience:
- Bachelor’s degree or equivalent experience in Business or Quality Management, Engineering, Math, or another related Life Sciences field degree.
- Seven years of technical experience that included process optimization and/or quality improvement project management in a life sciences compliance environment (cellular therapy, pharmaceutical, or medical device).
- Proven record in leading significant transformational improvements and delivering breakthrough results.
PREFERRED QUALIFICATIONS: (Additional qualifications that may make a person even more effective in the role, but are not required for consideration)
- Professional certification such as Certified Change Management Professional (CCMP), Project Management Professional (PMP), Certified Six Sigma Blackbelt (CSSBB), Certified Quality Process Analyst (CQPA) or similar.
- Strong familiarity with quality system requirements and national regulations applicable to the cellular therapy, pharmaceutical, or medical device industries.
- Experience interacting with Business Analysts and software application owners in support of quality and regulatory processes.
Tools:
- Project management and process mapping software, Microsoft tools (SharePoint, Excel, Visio, PowerPoint).
Be The Match offers regular, full-time employees medical, dental, vision, life and disability, accident/critical illness/hospital, well-being, legal, identity theft and pet benefits. Retirement, paid time off/holidays, leave and incentive plans are also offered to eligible employees. Please reference this link for more information: Be The Match Benefit Information
- Driver Policy: No
- Career Category: Professional
- Pay Basis: Yearly
- Career Level: 5
- Schedule: Full-time
- Job Family: Quality
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