Operations Manager - cGMP Temperature-Controlled Logistics
FLSA Status: Exempt
Department: Life Sciences
Salary Range: $90,000 - $110,000
Reports to: Director of Life Science
Location: Tewksbury, MA
About Sterling
Sterling Corporation is New England’s leader in commercial moving, logistics, and specialized transportation services. For more than 60 years, Sterling has supported corporations, institutions, and facilities management partners with precision, professionalism, and care.
Position Summary
The Operations Manager is responsible for leading day-to-day operations of a cGMP-compliant, temperature-controlled storage and logistics facility supporting pharmaceutical, biologic, and medical device clients.
This role involves operational performance, regulatory, compliance, service execution, and workforce planning, while serving as a key liaison between site operations and Sterling Corporate functions, including billing, job coordination, and administrative workflows.
Operating in a growing, high-compliance environment, the ideal candidate will play a critical role in building scalable processes, developing the site team, and ensuring alignment between operational execution and corporate systems.
This is a hands-on leadership role, requiring both strategic oversight and direct operational involvement as needed.
Key Responsibilities
- Operational Leadership
- Lead daily operations across all temperature zones (Cryo, -80°C, -40°C, -20°C, 2–8°C, 15–25°C)
- Ensure efficient execution of inbound/outbound logistics, inventory control, and order fulfillment
- Own and track operational KPIs including accuracy, turnaround time, temperature integrity, and SLA performance
- Optimize workflows, labor utilization, and facility capacity
- Serve as the primary escalation point for operational issues and service disruptions
2. Corporate Liaison & Business Operations
- Act as the primary interface between the facility and Sterling corporate teams
- Coordinate with HQ on billing workflows, job setup, and service activation for client accounts
- Ensure accurate and timely communication of operational activity required for invoicing and financial tracking
- Support onboarding of new client services into billable and operational status
- Align site-level execution with corporate policies, administrative processes, and reporting requirements
- Identify and resolve gaps between operational workflows and corporate systems
3. Workforce Planning & Team Development
- Own hiring decisions, headcount planning, and organizational structure for site operations
- Recruit, onboard, and develop operations and warehouse personnel
- Establish staffing models aligned with current and projected business demand
- Train and enforce adherence to SOPs, GMP standards, and safety protocols
- Conduct performance management, coaching, and career development planning
- Build a culture of accountability, ownership, and compliance
4. Regulatory Compliance & Quality Systems
- Ensure full compliance with:
- FDA regulations (21 CFR Parts 11, 210, 211, 600, 820)
- ISO 9001:2015 and ISO 13485
- cGMP and GDP standards
- Partner closely with QA to maintain and continuously improve the Quality Management System (QMS)
- Lead operational readiness for client audits, internal audits, and regulatory inspections
- Ensure documentation accuracy, audit readiness, and data integrity across all systems
5. Temperature-Controlled Environment Management
- Oversee monitoring and performance of all controlled temperature environments
- Ensure continuous environmental monitoring systems remain compliant and operational
- Lead response, investigation, and documentation of temperature excursions and deviations
- Drive timely and effective CAPA implementation and follow-through
6. Inventory & Client Material Management
- Ensure complete chain-of-custody and traceability of all client materials
- Maintain strict material segregation, labeling, and handling protocols
- Oversee inventory control processes including cycle counts, reconciliations, and audits
- Support client onboarding, material intake, and lifecycle management
7. Process Improvement & Risk Management
- Identify and implement process improvements to enhance efficiency, scalability, and compliance
- Lead deviation investigations, root cause analysis, and CAPA execution
- Maintain and update operational risk assessments
- Drive continuous improvement initiatives aligned with business and quality objectives
8. Safety & Facility Oversight
- Ensure compliance with OSHA and workplace safety standards
- Oversee facility readiness, equipment performance, and maintenance programs
- Coordinate with vendors for calibration, validation, and preventive maintenance activities
- Support emergency response readiness, including participation in alarm escalation or response protocols
Qualifications
Required
- Bachelor’s degree in supply chain, Life Sciences, Operations, or related field (or equivalent experience)
- 5+ years of operations leadership experience in a regulated environment (pharma, biotech, medical device, or healthcare logistics)
- Demonstrated experience with team leadership, hiring, and workforce planning
- Strong working knowledge of cGMP, GDP, and FDA regulatory frameworks
- Experience with temperature-controlled storage or cold chain logistics
- Experience coordinating cross-functional workflows with corporate or administrative teams
- Demonstrated experience supporting audits and regulatory inspections
Preferred
- Experience operating within ISO 9001 and/or ISO 13485 environments
- Familiarity with electronic QMS, ERP, inventory, or billing systems
- Lean, Six Sigma, or continuous improvement training
Core Competencies
- Regulatory rigor and compliance mindset
- Operational execution in controlled environments
- Strong cross-functional communication and coordination
- Leadership, hiring, and team development
- High attention to detail and data integrity
- Problem-solving and root cause analysis
- Business and client service orientation
Working Conditions
- On-site role within a temperature-controlled warehouse environment
- May require availability outside standard hours for critical operations, excursions, or escalations
- Exposure to cold storage environments and use of PPE
Success Metrics (KPIs)
- Inventory accuracy and traceability
- Audit outcomes (internal, client, regulatory)
- Temperature excursion frequency and resolution time
- On-time fulfillment and SLA adherence
- CAPA closure timelines
- Employee training and retention
- Hiring effectiveness and staffing alignment to demand
- Billing accuracy and timeliness
- Alignment between operational execution and corporate workflows
Qualified candidates should forward their resumes to: HR@sterlingmail.com.
Sterling is an equal opportunity employer
