Senior Manager, Quality & Compliance

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About The Position

As a Senior 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.

Requirements

• 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.

Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees