Senior Manager, Quality & Compliance

Reposted 6 Days Ago
Be an Early Applicant
Groveport, OH
In-Office
Senior level
eCommerce • Logistics • Professional Services • Software • Analytics • 3PL: Third Party Logistics
Sell and fulfill anywhere.
The Role
Manage quality and compliance functions in pharmaceutical logistics, ensuring FDA and regulatory standards are met while driving operational excellence and continuous improvement.
Summary Generated by Built In

Job Description:

Who We Are: 

We’re Cart.com, one of the fastest growing commerce enablement companies in the world. We provide the digital and physical infrastructure that empowers thousands of leading B2C, B2B and public sector organizations to unify commerce operations from product discovery to product delivery. 

  

We’re building toward a world where commerce has no bounds. Our enterprise-grade software, services and logistics infrastructure, including our own network of omnichannel fulfillment and distribution centers, enable merchants to navigate an increasingly complex operating landscape and drive efficient growth. 

  

Our goal is to be the global backbone of commerce. To achieve it, we’re looking for entrepreneurial, innovative and determined teammates who are eager to help our growing base of customers simplify their commerce operations and seamlessly reach their own customers, wherever they are. Sound like you? We’d love to hear from you. 

 

Cart.com Fast Facts: 

  • 6,000+ customers worldwide 

  • 1,600+ employees globally 

  • 17 warehouses nationwide, totaling over 10 million square feet of space 

  • Headquartered in Houston, TX with international offices in Mexico and Poland 

 

Our values: 

Cart.com is building a company that is committed to living out these 6 core values: 

  • Be brand obsessed: Our lives are shaped by the brands we interact with daily. We obsess over the brands we serve, and about the things they care about. 

  • Think beyond the box: “We’ve always done it that way” is not a phrase uttered often at our office. We create creative solutions to complex problems. 

  • Don’t give up: We learn from our challenges and see them for what they are; great building blocks to an amazing brand story. 

  • Speak up: We communicate clearly and directly because we care deeply. Communication is the bedrock of our community. 

  • Work together: We’ve built a team that prides itself on diversity of thought and background. Collaboration is better with contrast. 

  • Remember to be human: We work hard, but we leave room for the people, places and things that we love. 

 

Onsite: 
This position is open to applicants or individuals who are located in or around Groveport,OH. The role is an onsite role with some travel expectations and opportunity to work from home at times.  
 

The Role:   

As aSenior Manager, Quality & Compliance, you will oversee and enhance quality and compliance functions across our pharmaceutical and life sciences fulfillment network. This role ensures compliance with FDA, cGMP, GDP, and global regulatory standards while driving operational excellence across multiple cold chain and ambient environments. You will lead a team and partner with operations leadership. You play a key role in continuous improvement, audits, and risk mitigation. 

This is a hands-on leadership role responsible for scaling compliant operations while ensuring day-to-day quality control and long-term strategic readiness. 

What You’ll Do: 

Quality & Compliance Leadership 

  • Oversee quality operations across one or more life sciences fulfillment centers. 

  • Implement and monitor SOPs to ensure compliance with FDA, NSF, cGMP, GDP, USP <1079>, EU GDP, and WHO guidelines. 

  • Coordinate and lead internal audits, client audits, and support Director in FDA and regulatory inspections. 

  • Partner with supervisors and associates to maintain quality assurance at the operational floor level. 

Regulatory & Risk Management 

  • Ensure documentation, deviation reports, and CAPAs are effectively managed and closed on time. 

  • Support Director in preparing regulatory submissions, reports, and compliance updates. 

  • Develop and oversee site-level risk assessments, corrective actions, and preventive controls. 

  • Ensure facilities adhere to OSHA and safety standards in cold-chain operations. 

Cold Chain & Validation 

  • Oversee validation and monitoring of temperature-controlled storage, ranging from ambient to ultra-low (-90°C). 

  • Review data logs, deviation reports, and corrective actions related to temperature excursions. 

  • Partner with maintenance and operations teams on equipment qualification, calibration, and environmental monitoring. 

People Management & Training 

  • Directly manage Quality Supervisors and Specialists, ensuring clear accountability and development. 

  • Deliver training programs on compliance, audits, and regulatory standards for front-line staff and leadership. 

  • Serve as escalation point for quality incidents, providing guidance and decisions in real time. 

Continuous Improvement 

  • Identify gaps and implement process improvements across quality systems, documentation, and training. 

  • Develop site- and network-level KPIs to monitor compliance and drive efficiency. 

  • Foster a culture of proactive compliance, problem solving, and accountability. 

 

 

Who You Are: 

  • Strategic yet hands-on leader who can influence up, down, and across functions. 

  • Skilled communicator who balances regulatory rigor with operational execution. 

  • Collaborative leader who can develop, coach, and elevate front-line supervisors and specialists. 

  • Able to thrive in a highly regulated, fast-paced, and scaling logistics environment. 

 

What You’ve Done: 

  • 5+ years of progressive experience in quality assurance, compliance, or regulatory affairs in pharma, biotech, or life sciences logistics. 

  • Experience leading teams (supervisors/specialists) and partnering with operations leadership. 

  • Proven success in supporting FDA inspections, audits, and regulatory interactions. 

  • Knowledge of cGMP, NSF, GDP, USP <1079>, EU GDP, and WHO guidelines. 

  • Strong experience with CAPA, deviation management, and risk assessment. 

  • Hands-on experience in cold chain operations (ambient to -90°C). 

Nice to Haves:  

  • Bachelor’s degree in Quality Assurance, Life Sciences, or related field. 

  • ISO 9001, Lean Six Sigma, or Regulatory Affairs certification. 

  

Currently, Cart.com does not intend to hire candidates who will need, now or in the future, Cart.com sponsorship through any non-immigrant visa category such as the H-1B, H-1B1, E-3, O-1, or TN.  

   

All hiring is contingent on eligibility to work in the United States. We are unable to sponsor or transfer visas for applicants. 

Cart.com is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Top Skills

Cgmp
Fda
Gdp
Iso 9001
Lean Six Sigma
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The Company
HQ: Austin, TX
1,400 Employees
Year Founded: 2020

What We Do

Cart.com is the leading provider of unified commerce and logistics solutions that enable B2C and B2B companies to sell and fulfill anywhere their customers are. The company’s enterprise-grade software, services and logistics infrastructure, including its own network of omnichannel fulfillment and distribution centers, are used by some of the world’s most beloved brands and most complex organizations to unify commerce operations across channels and drive more efficient growth.

For more information, please visit Cart.com and LinkedIn.

Why Work With Us

We are a team who live by our core values.

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