Senior Manager Quality Assurance, Regulatory Compliance

| Peninsula | Hybrid
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Passionate about precision medicine and advancing the healthcare industry?

Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.

We are looking for a Manager/Sr Manager - Quality System and Regulatory Compliance who will 

  • Implement and maintain Quality Management System (QMS) as per the requirements of FDA QSR (21 CFR 820), ISO 13485 and other applicable regulatory requirements, as well as best practices in quality management.
  • Support and improve compliance status of various QMS activities.
  • Lead eQMS implementation across multiple QMS activities.
  • Oversee regulatory compliance activities including conducting internal audits, ensuring inspection readiness, and hosting external inspections. 

This role’s primary responsibility is to support the organization’s mission of maintaining regulatory compliance while ensuring business goals of efficiently bringing new innovations and products to market, and reports to the Vice President of Quality Assurance.

Responsibilities

  • Continued implementation and maintenance of medical device/IVD QMS (ISO 13485/FDA QSR) - in harmonization with LDT (CLIA/CAP) QMS including GCLP (Good Clinical Lab Practices):
    • Responsible for evaluating and implementing company compliance with all applicable domestic and international standards and regulations.
      • Responsible for actively monitoring the regulatory landscape including updates and changes.
    • QMS procedures: Develop new or edit existing QMS documentation and SOPs for adherence to these standards and regulations.
    • Identify Quality Initiatives and lead cross-functional teams to complete them.
    • Establish strong connection and collaboration with business partners cross-functionally, e.g. Quality, Regulatory, R&D, Engineering, Supply Chain and Operations for this purpose. 
    • Adopt a proactive approach to regulatory compliance while incorporating best practices in quality management in each domain. 
  • Support and improve compliance status of various QMS activities:
    • Oversee or support QMS activities across multiple domains, such as CLIA/CAP, GCLP/GCP, ISO 13485 and FDA regulated environments.
    • Support QMS activities such as CAPA, NCR, deviation, issue and complaint management. 
    • Support Post Market Surveillance activities, recalls, corrections, and medical device reporting. 
    • Review technical data and quality metrics across all areas to ensure compliance standards are met; identify opportunities for improvement and take action as necessary.
    • Prepare materials for management reviews, and present as needed.
    • Complete training on medical device standards, regulations, and company QMS procedures to the staff as required.
    • Supports the supplier quality program.
    • Mentor and develop Quality personnel, specialists and engineers. 
    • Complete QMS inquiries and questionnaires from potential customers/partners.
  • Lead eQMS implementation across multiple QMS activities:
    • Lead implementation of eQMS (eTQ) modules such as complaints, supplier, audits, CAPA, NCRs, and others. 
    •  Lead the required workflow improvements (including defect resolution and reconfigurations) of eTQ modules already implemented such as Doc Control, Change Control, training and eMDR.
    • Support the ongoing maintenance of eQMS/eTQ. 
    • Works autonomously with the external vendor, as well as internal cross-functional stakeholders and SMEs for this purpose.
  • Regulatory compliance activities:
    •  Ensure audit readiness for external audits - regulatory agencies/FDA PAI, notified body/ISO 13485, and pharma partners. Act as a change leader, responsible for execution of major readiness and compliance initiatives.
    • Oversee and facilitate such external audits, including drafting audit responses. 
    • Work with area management to address audit findings, drive opportunities for improvement and address potential gaps/preventive actions.
    • Responsible for the internal audit program - conducting internal audits including follow-up activities to closure.  
    • Conducting supplier audits as necessary. 
    • Serves as a notified body interface, including switching from one to another.

Required Qualifications

  • Bachelor’s Degree or higher, preferably in Engineering or Science disciplines
  • 5+ years in a management capacity
  • 8+ years of quality systems and regulatory compliance experience in the FDA regulated environment - medical devices or IVDs.
  • Previous experience with hosting external agency inspections. 
  • Detailed knowledge of FDA Quality System Regulations, ISO 13485:2016, ISO 14971, MDSAP and EU-IVDR.
  • Excellent organizational, interpersonal, verbal and written communication skills,  with ability to effectively communicate at multiple levels in the organization.
  • eQMS experience preferred.
  • Demonstrated and impactful project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
  • Advanced computer skills, including statistical/data analysis and report writing.
  • Multitasks, prioritizes and meets deadlines in a timely manner. 
  • Ability to travel,l approximately 25%.
  • RABQSA ISO 13485 lead auditor, ASQ CQA certification preferred.
  • Demonstrated ability to operate and innovate in teams with a fast‐paced environment, balancing business, compliance, and strategic needs.


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Location

Our Redwood City office is located in a waterfront neighborhood at the heart of Silicon Valley, providing convenient access to tech hubs and boasting a thriving business scene. With excellent transport options and a range of dining choices, it's a dynamic hub for professionals and tech enthusiasts.

An Insider's view of Tempus AI

What’s the vibe like in the office?

The casual setting here in the Chicago office makes everyone less intimidating and more approachable. It's nice to be in an environment where our day-to-day work actually makes a difference, I feel valued. Tempus is also great at welcoming everyone with different backgrounds.

Alexis

Clinical Lab Associate

How do you collaborate with other teams in the company?

I collaborate with various hiring teams on a daily basis. Through weekly meetings, strategic planning, events, and messaging, hiring teams and I have built a collaborative hiring process and have become trusted partners to bring top talent to Tempus. We rely on honest communication, shared goals, and the right tools to set us up for success!

Emma

Recruiter

How does the company support your career growth?

I am always looking for the next opportunity to grow my career, and Tempus has a wealth of opportunities in many departments. Through emerging leaders programs and ongoing conversations with my managers, Tempus has always been supportive in guiding me to find work that is fun, interesting, and maximizes my potential.

Aaron

Senior Operations Manager

What are some things you learned at the company?

One of the things that molded my growth was seeing how much thought goes into the decisions, and how much leadership seeks feedback from the people around them, to help understand the impact of decision-making. Just being a sponge in the room is inspiring. I adapted the styles of many leaders here and use that to create my own leadership style.

Anita

Laboratory Operations Manager

What are Tempus AI Perks + Benefits

Tempus AI Benefits Overview

Health Insurance
Dental Insurance
Vision Insurance
Life Insurance
Short-Term Disability Insurance
Flexible Spending Account
Commuter Benefits
Parental Leave
Charitable Matching Program
Employee Assistance Program (EAP)
Pet Insurance
Company Cafeteria with Breakfast, Lunch & Grab & Go Options
Stocked Kitchen with Snacks
On-Site Barista
Discounted Gym Membership
Discounted Divvy Membership
Diversity & Inclusion Initiatives
Team & Company Outings

Culture
Volunteer in local community
Open door policy
OKR operational model
Team based strategic planning
Pair programming
Open office floor plan
Employee resource groups
Employee-led culture committees
Hybrid work model
Flexible work schedule
Remote work program
Diversity
Highly diverse management team
Diversity employee resource groups
Hiring practices that promote diversity
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Disability insurance
Dental insurance
Vision insurance
Health insurance
Life insurance
Pet insurance
Wellness programs
Mental health benefits
Financial & Retirement
401(K)
Company equity
Charitable contribution matching
Child Care & Parental Leave Benefits
Generous parental leave
Family medical leave
Vacation & Time Off Benefits
Unlimited vacation policy
Generous PTO
All staff in Tempus’ laboratories are subject to Tempus’ separate laboratory PTO policies.
Paid volunteer time
Paid holidays
Paid sick days
Flexible time off
Bereavement leave benefits
Office Perks
Commuter benefits
Company-sponsored outings
Free snacks and drinks
Some meals provided
Company-sponsored happy hours
Onsite office parking
Recreational clubs
Relocation assistance
Professional Development Benefits
Job training & conferences
Lunch and learns
Promote from within
Mentorship program
Continuing education available during work hours

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