Sr. Global Quality Systems Specialist, QA - Boston MA - 14852
Boston MA, MA 02210
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Title: Sr. Global Quality Systems Specialist, QA
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
- Duration: Temp
- Pay rate: $37-42/hr
- Job Location: Boston MA/Remote
- Job#: bh14280
Sr. Global Quality Systems Specialist, QA
The Global Quality Systems Sr. Specialist will work cross-functionally to support the needs of Global Vendor Quality System. This support includes execution of activities related to the design, oversight, and monitoring of the health of vendors and reporting metrics to the stakeholders across the operational areas including GxP Global disciplines, modalities (small molecule, cell/gene therapies, medical devices), technologies and countries/regions globally.
- individual will work closely with Quality System / Process Owners and across the organization to build scalable Vendor Quality system and process to ensure consistency in execution across all functional GxP areas.
This individual will demonstrate Core Values, as well as model leadership behaviors instilling a culture of quality, engagement, development, and transparency.
Supports the day-to-day management of Vendor Quality Management System which includes the design, deployment, oversight, and monitoring of the health of vendors and KPIs. Key activities include
- Support management in developing and achieving strategic initiatives leading to the maturity of our Vendor Quality Management system to ensure sustainability, scalability, and efficiency of global quality systems for meeting emerging and future business needs across modalities (e.g., cell, gene, device, vectors), GxP areas, and geographies.
- Serves as project coordinator / manager for Vendor Quality Systems projects and governance teams
- Drives data consistency and accuracy in the Vendor Quality Management System
- Generates Metrics / KPIs and develop Dashboards and Reports to support business
- Drive cont. improvement in metrics related to vendor management by collaborating with both internal (all modalities) and external (vendors) stakeholders
- Assists in the creation / maintenance of document and training materials
- Communicates with team, stakeholders, and management on progress on goals and project deliverables
- Completes assigned tasks independently with the ability to troubleshoot, make decisions and proactively communicates risks to ensure timely remediation
- Consistently demonstrates an ongoing commitment to achievement of QA goals, as well as the success of all team members consistent with phenotype
REQUIRED KNOWLEDGE, SKILLS, AND COMPETENCIES
Key Leadership Skills:
- Learn, Teach, Develop
- Lead by example
- Foster exceptional collaboration
- Drive breakthrough results
- Promote enterprise thinking
Key QA Competencies:
- Business Minded Leader
- Understand how QA work supports the goals of the business.
- Recognize the purpose of the functional areas within Quality and across the organization, and how they support the success of the business.
- Understand how one’s work contributes to the vision and mission, as it relates to company’s ability to benefit the lives of patients and other stakeholders.
- Understand the balance between compliance and business requirements, and contribute to the development of efficient solutions.
- Trusted Partner
- Align and adjust activities within one’s scope of ownership to positively impact business results.
- Encourage others to contribute their perspectives with candor.
- Influence others by leveraging active listening, and deliver articulate and convincing ideas.
- Understand the full range of voices and bring them to the decision making process when addressing key
- Develop solutions that fully address business and patient needs and align with QMS standards.
- Functional and Technical Expert
- Build and leverage one’s technical expertise to recognize issues and risks for resolution.
- Understand and apply technical expertise to positively impact one’s own effectiveness.
- Understand the current state of the industry and develop a basic knowledge of the regulatory space.
- Support the mitigation of issues to support quality compliance and excellence within one’s area of focus,
- Troubleshooting and escalating risks as appropriate.
- Planner, Organizer, And Executer
- Apply project management skills to lead project teams in a highly impactful manner.
- Identify and raise risks to the timeliness or quality of deliverables to the project team and stakeholders, and contribute to resolution.
- Carry out appropriate analysis based on the risk/issue, and take action to mitigate potential risks and deficiencies when making decisions.
- Recognize risks and issues impacting the budget, and develop recommendations for mitigation across scope of responsibility.
- Prioritize tasks and projects to facilitate execution of work.
- Change Enabler
- Support enablement of change efforts within one’s area or function.
- Adapt to change within one’s area or function, and demonstrate optimism and resilience during times of change.
- Continue to perform job responsibilities effectively when the situation is ambiguous or especially challenging.
- Creative and Impactful Thinker
- Leverage critical thinking to assess and resolve, or escalate, defined issues with uncertain cause.
- Suggest improvements for direct work area.
- Assist in the design and implementation of solutions that improve quality performance within one’s area of
- Demonstrate digital fluency and openness to new ways of working, and build knowledge in emerging
- technologies, operating models, and science related to direct work responsibilities.
Key Technical Knowledge and Skills
- Basic regulatory compliance and quality management experience (across multiple GxP areas) preferred
- Demonstrated experience in supporting the design, management, and improvement of global quality systems/processes
- Project management knowledge and experience
- Creative thinker complemented with change management experience, adaptability, resourcefulness
- Strong communication, problem solving and critical thinking skills, accompanied by Analytical thinking/Data Analysis skills required to make sound decisions
- Ability to work under minimal supervision
- Ability to work and coordinate cross-functionally
- Proficiency in using Microsoft Office applications
- Experience with quality management applications such as Veeva
PREFERRED EDUCATION AND EXPERIENCE:
- Bachelor’s Degree with a min of 2-5 years of relevant work experience
Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.
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