Global Program Manager - Post Market Quality
1 week ago
Job type: Full-time
Hiring from: USA Only
Category: All others
Location: Remote, United States OR San Francisco, CA
ABOUT JUUL LABS
JUUL Labs’ mission is to transition the world’s billion adult smokers away from combustible cigarettes, eliminate their use, and combat underage usage of our products.
We have the opportunity to address one of the world’s most intractable challenges through a commitment to exceptional quality, research, design, and innovation. Backed by leading technology investors, we are committed to the same excellence when it comes to hiring great talent.
We are a diverse team that is united by this common purpose and we are hiring the world’s best engineers, scientists, designers, product managers, operations experts, and customer service and business professionals. If the opportunity to build your career at one of the fastest growing companies is compelling, read on for more details.
ROLE AND RESPONSIBILITIES:
The Global Program Manager – Post-Market Quality is responsible for supporting the operation and maintenance of the Quality Management System as it relates to Post-Market Surveillance. The position identifies continuous improvement opportunities and develops, deploys and maintains global harmonized processes in compliance to established and evolving regulatory requirements. The position requires the ability to drive strategic activities while also managing tactical activities and communicating effectively with stakeholders.
- Plan and manage the execution of complex quality and regulatory projects globally relating to integration, process standardization or improvement, supporting a global center of excellence for complaint handling.
- Maintain the overall project plan and provide line of site for critical milestones across multiple workstreams and quality focused projects
- Conducts routine meetings to ensure accountability and milestone achievements with team(s). Sets prioritization activities and follow up on actions.
- Actively seeks collaboration and builds relationships with internal customers and external partners to improve overall outcomes and timely project completion.
- Proactively identify and assess areas of risk, escalate issues in a timely manner and proactively propose solutions. Implement and manage project changes and interventions to achieve timely project outputs.
- Develop a team culture of continuous improvement and teamwork that strives to improve quality.
- Aid in development and maintenance of key performance indicators for post-market surveillance, ensuring that the KPIs are within the required scope.
- Lead and support corrective action, process, policy and continuous improvement projects.
- Continuously review requirements and processes to ensure compliance to business and regulatory needs.
- Timely communication of business-related issues or opportunities to the next management level.
- Subject Matter Expert (SME) in regulatory audits, internal audits and inspections as appropriate to represent and defend the post-market surveillance plan.
- Additional responsibilities may be assigned.
PERSONAL AND PROFESSIONAL QUALIFICATIONS:
- 5+ year Quality Management Systems (QMS) Experience: The ideal candidate will have experience leading QMS projects ideally for medical device / pharma. Experience with global product complaints including, medical information call center processes, complaint handling, consumer safety, adverse events, product sample return, clinical and product investigation process, etc.
- 3+ years of Project/Program Management Experience: Risk management, timelines, budget management, communications, change management, problem solving, PMO experience, resource management.
- Demonstrated understanding of FDA 21 CFR Part 820, ISO Standards, EU MDR and Tobacco regulations.
- Critical thinking and investigation skills. May receive technical guidance on complex problems, but independently determines and develops approaches and solutions.
- Well organized and able to take on multiple initiatives in an ambiguous environment.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Demonstrated ability to understand and follow complex written procedures.
- Knowledge of general quality management system concepts, including good documentation practice (GDP), corrective and preventive action (CAPA), and document change control practices.
- Demonstrated ability to influence and drive change.
- American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools is preferred.
- Bachelor’s degree in Engineering, Technology, Science related field.
JUUL LABS PERKS & BENEFITS:
- A place to grow your career. We’ll help you set big goals - and exceed them
- People. Work with talented, committed and supportive teammates
- Equity and performance bonuses. Every employee is a stakeholder in our success
- Boundless snacks and drinks
- Cell phone subsidy, commuter benefits and discounts on JUUL products
- Excellent medical, dental and vision benefits
Before you apply, please check if any restrictions apply in terms of time zone or country.
This job has a geo-restriction in place: USA Only.
Please mention that you come from Remotive when applying for this job.
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