Clinical Operations Manager Jobs in Frederick, MD

SriSai Biopharmaceutical Solutions (SBS) is seeking an experienced and results-driven Operations Manager to lead daily biorepository and operational activities at our Frederick, Maryland facility.

This is an opportunity for a strong operations leader who thrives in a structured, highly regulated environment and understands that operational excellence depends on accuracy, consistency, accountability, compliance, and strong team leadership.

The Operations Manager will oversee key operational functions including sample receiving and intake, Packaging & Labeling, inventory storage and tracking, shipping, and distribution, while ensuring all work is performed in accordance with established SOPs, GxP requirements, quality standards, and company expectations.

In this role, you will:

• Lead and oversee daily biorepository and operational workflows.
• Manage activities related to sample receiving, Packaging & Labeling, inventory management, shipping, and distribution.
• Ensure operational activities are performed accurately and consistently according to established SOPs.
• Monitor daily workflow and address deviations or operational issues in real time.
• Help prevent receiving errors, shipment errors, inventory discrepancies, and unnecessary rework.
• Monitor operational KPIs and use performance data to identify opportunities for improvement.
• Ensure documentation is accurate, complete, compliant, and audit-ready.
• Reinforce GxP requirements and support Quality Assurance during audits, inspections, CAPAs, and other compliance activities.
• Supervise, coach, and develop frontline employees while promoting accountability and teamwork.
• Ensure employees understand procedures, execute their responsibilities correctly, and maintain documentation accuracy.
• Support employee onboarding, training, competency, and professional development.
• Collaborate closely with Quality Assurance, Human Resources, Finance, IT, and Facilities.
• Support reliable operation of critical biorepository infrastructure, including ultra-low temperature freezers, temperature monitoring systems, alarms, and backup power systems.
• Respond appropriately to operational risks, equipment issues, temperature excursions, and other situations that could affect sample integrity or business continuity.
• Contribute to continuous improvement initiatives designed to strengthen quality, efficiency, and operational performance.

These responsibilities reflect the JD's emphasis on SOP compliance, training, daily performance management, team supervision and cross-functional collaboration.

The successful Operations Manager will build a disciplined, high-performing operation where quality and accuracy are part of everyday execution.

Key performance expectations include:

• ≥98% error-free shipments
• ≥98% labeling accuracy
• 97–99% inventory accuracy
• Reduction in operational errors and rework
• Consistent SOP adherence across shifts
• 100% training completion for assigned employees
• Demonstrated employee competency
• No critical errors affecting sample integrity, chain-of-custody, or temperature control
• Strong team performance with reduced operational escalations

These measures come directly from SBS's defined success criteria for the role.

• Bachelor's degree or equivalent relevant experience.
• 5+ years of experience in operations, logistics, or a regulated environment.
• Demonstrated experience managing teams in a structured operational environment.
• Strong understanding of SOPs and compliance requirements.
• Strong organizational, analytical, and problem-solving skills.
• Ability to lead employees with clear expectations, accountability, consistency, and professionalism.
• Ability to work effectively across multiple departments in a fast-paced environment.

We are especially interested in candidates who have:

• Experience in biorepository operations, clinical trials, or life sciences.
• Experience working in a GxP/GMP-regulated environment.
• Familiarity with inventory management systems or WMS platforms.
• Experience supporting highly controlled materials, samples, or temperature-sensitive operations.

The preferred experience above is specifically identified in the SBS JD.

Beyond technical experience, we are looking for someone who can create a workplace where employees understand what is expected, procedures are followed consistently, issues are addressed quickly, and people are held accountable in a fair and professional manner.

The ideal candidate is a leader who can balance people leadership, operational execution, quality, compliance, and continuous improvement while maintaining the discipline required in a regulated life sciences environment.

SriSai Biopharmaceutical Solutions (SBS) is a trusted pharmaceutical support and manufacturing partner committed to excellence in service and execution.

Our culture is guided by our RICE values:

• Respect – We treat others with dignity and professionalism.
• Integrity – We act with transparency, honesty, and accountability.
• Customer-Centered – We prioritize responsiveness and reliability.
• Excellence – We pursue high standards in everything we do.

If you are an experienced operations professional who is passionate about leading teams, strengthening processes, maintaining compliance, and delivering reliable results in a regulated environment, we would like to hear from you.

Join SBS and help us continue building an operation defined by quality, accountability, consistency, and excellence.

SriSai Biopharmaceutical Solutions, LLC (SBS) is an Equal Opportunity Employer. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, disability, veteran status, or any other protected category under federal, state, or local law.