This REMOTE based position - QA Project Manager – Quality and Compliance Improvement role is responsible for the identifying and leading small and medium projects; and participating as a key contributor for large projects to correct quality and compliance problems; implement improvements in quality and compliance; and assure continued compliance with evolving quality and compliance requirements.
- Understands requirements and processes for Best in Class Quality Management Systems
- Leads small to medium cross functional and multi-site initiatives to identify, develop, modify, improve, and implement global process solutions for compliant Quality Systems.
- As a Project Leader, oversees all aspects of project scope, schedule, resource risks and overall management to ensure and drive successful delivery.
- Ensure deliverables/milestones in project plans are achieved within cost, schedule, scope, quality and delivery
- Assists in development of policies and procedures supporting Quality Systems
- Develops and delivers training curriculum and content for Quality Systems processes
- Through the analysis of Quality and Compliance processes, and understanding of industry best practice, collect and translate Quality insights, ideas and concepts into clearly defined requirements for process improvements
- Demonstrates enthusiasm, takes accountability and drives for results.
- Ensure that solutions implemented are scalable, flexible and consistent in all regions whenever possible.
- Coordinate with global counterparts to determine and communicate global impact of proposed changes.
- Participates in industry and other professional networks to ensure awareness of industry standards, trends and best practices in order to strengthen Quality Systems knowledge
- Consultants/ Vendors
- Others, including:
- Service & Customer Support Management
- Supply Chain
- Strong expertise and practical experience with Project Management concepts and processes
- Ability to lead small to medium cross functional and multi-site initiatives for the investigation and identification and retooling of process and systems solutions, and the development and deployment of these solutions to enable best in class Quality Systems. Projects may be multi-site and multifunctional in scope.
- Proven ability to lead groups, manage deliverables, and maintain client relationships
- Experience in developing and managing a project plan and priorities
- Demonstrates significant knowledge and work experience in relevant Quality Systems functional areas, processes, and best practices, including CAPA management, Complaint Handling, Document Control, Change Control, QRB
- Excellent written and oral communication skills; ability to communicate effectively with Senior Leadership and all levels below; ability to prepare high quality presentations and deliver them effectively
- Ability to execute training needs analysis, prepare curriculum and deliver functional and advanced training.
- Ability to enable cultural transformations; act as a role model; and manage change
- Exceptional interpersonal skills, including teamwork, facilitation, and negotiation
- Ability to make decisions in the face of uncertainty and complex situations
- In-depth industry related knowledge – Quality Systems best practices and policies
- Expert knowledge in compliance with quality standards (i.e., GMP, ISO regulations)
- Understanding of business processes – Quality Systems
- 6 Sigma, PPI, or Lean training a plus.
Additional Job Abilities
- Requires the ability to perform independently and/or as part of a team and to lead small to medium cross functional and/or multi-site projects
- Exercises leadership, initiative, and self-sufficiency while keeping management and stakeholders appropriately involved and informed.
- Ability to solve problems, remove roadblocks, and deal with a variety of variables in unique situations.
- Instill customer satisfaction that is recognizable and valuable to the customer.
- Able to work independently without significant direction, exercising leadership and self-sufficiency while keeping management and stakeholders appropriately involved and informed
- Works effectively in a virtual team environment.
- Exceptional interpersonal and communication skills (includes verbal, written, and presentation) to be able to liaise with colleagues, management, chief executives, and other senior people inside the organization on a regular basis.
- Produces polished, original, formal presentations for all sizes of audiences including large audiences.
- Bachelors Degree in Engineering, Science, or related field
- Must have a minimum of 4 year’s experience in a Quality Systems role with some experience in leading improvement initiatives supporting Quality and Compliance and the successful completion of various quality or compliance improvement projects varying in size and complexity.
- Expertise in ISO 9001 and/or ISO 13485, GMP requirements
- Experience in Operations a plus
- The work environment characteristics described here are representative of those an employee encounters while performing the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- This position may require approximately 25% travel. The travel may be both domestic and international.
- This position is based remotely
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