Operations Project Manager

SriSai Biopharmaceutical Solutions, LLC; Frederick (MD); On-site; USD 90,000 - 130,000; Full time

Job summary

SriSai Biopharmaceutical Solutions, LLC in Frederick, MD, is seeking an Operations Project Manager to lead cross-functional projects from planning through delivery. The role emphasizes independent judgment, risk mitigation, and maintaining audit-ready documentation in a regulated environment.

You will coordinate with Quality, Facilities, Validation, and Operations, manage timelines and deliverables, and provide coverage as needed to ensure safe, compliant, and efficient operations.

Qualifications

• Bachelor's degree or equivalent in a related field.
• 5+ years in operations/project management in regulated environments.
• Experience planning and coordinating cross-functional initiatives.
• Ability to manage multiple priorities with limited supervision.
• Experience in GMP-regulated settings preferred.

Responsibilities

• Independently manage Operations projects from planning to completion.
• Develop project plans, timelines, milestones, deliverables, and action plans.
• Lead project meetings and ensure cross-department alignment.
• Coordinate activities across Operations, Quality, Facilities, Validation, and other departments.
• Monitor progress, risks, and action items; provide status updates.
• Provide backup management coverage when assigned.
• Maintain audit-ready project documentation.
• Identify inefficiencies and implement process improvements.

Skills

End-to-End Project Management

Cross-Functional Collaboration

Risk Assessment & Mitigation

Analytical Problem-Solving

Effective Communication

Education

Bachelor's degree in Operations, Business Administration, Life Sciences

Job description

Position Summary

The Operations Project Manager is an individual contributor responsible for independently planning, leading, and executing operational projects and continuous improvement initiatives across SriSai Biopharmaceutical Solutions.

This position provides end-to-end project management, including establishing project timelines, milestones, deliverables, and priorities; coordinating cross-functional activities; mitigating risks; and ensuring successful project completion.

The role requires independent judgment, strong problem-solving skills, effective communication, and the ability to manage multiple priorities with limited day-to-day supervision. The position is also responsible for identifying operational inefficiencies and implementing improvements that support safe, compliant, and efficient operations.

Additionally, the Operations Project Manager serves as a designated backup for Operations supervisors or managers during scheduled or unscheduled absences. When formally assigned to provide management coverage, the position assumes responsibility for directing employees, assigning work, making operational decisions, and maintaining the performance of the assigned operational area.

Essential Duties and Responsibilities

Project Management and End-to-End Delivery

• Independently manage assigned Operations projects from initial planning through implementation and successful completion.
• Develop project plans, timelines, milestones, deliverables, responsibilities, and action plans.
• Establish project priorities and determine appropriate next steps based on business objectives and operational requirements.
• Lead project meetings to define deliverables, establish accountability, and ensure alignment among participating departments.
• Coordinate cross-functional project activities with Operations, Quality, Facilities, Validation, and other departments.
• Monitor project progress, deadlines, resource requirements, risks, and outstanding action items.
• Identify potential project delays or barriers and independently develop and recommend appropriate solutions.
• Evaluate project risks and implement mitigation strategies to maintain progress and achieve established objectives.
• Provide regular project status updates to leadership, including milestones achieved, outstanding issues, potential risks, and recommended actions.
• Maintain accurate project documentation and ensure timely completion of assigned deliverables.

Process and Workflow Optimization

• Evaluate existing operational processes and workflows to identify inefficiencies, operational barriers, and opportunities for improvement.
• Recommend and implement new processes, equipment, systems, and operational practices that improve efficiency, safety, quality, and productivity.
• Lead assigned operational improvement initiatives from evaluation through implementation.
• Collaborate with cross-functional departments to assess operational challenges and develop sustainable solutions.
• Exercise independent judgment in evaluating alternatives, establishing improvement priorities, and recommending appropriate courses of action.
• Support implementation of new technologies, systems, equipment, and operational changes.
• Evaluate the effectiveness of implemented improvements and recommend additional changes when necessary.

Compliance and Audit Readiness

• Maintain accurate project records, supporting documentation, and action tracking to ensure continuous audit readiness.
• Coordinate and support corrective and preventive actions associated with operational projects and improvement initiatives.
• Identify potential compliance risks and recommend appropriate preventive or corrective measures.
• Collaborate with Quality and other departments to ensure operational changes comply with applicable policies, procedures, and regulatory requirements.
• Support internal and external audits, inspections, investigations, and follow-up activities as assigned.
• Track corrective actions and ensure assigned project-related commitments are completed within established timelines.

Temporary Operations Management Coverage

• Assume responsibility for the daily management, performance, and operational effectiveness of the assigned area.
• Independently establish daily work priorities based on staffing, workload, customer requirements, safety, quality, and operational needs.
• Assign and reassign employees to work areas, functions, and responsibilities using independent judgment.
• Determine the appropriate utilization of available staffing and operational resources.
• Direct employees in performing assigned responsibilities and adjust priorities as operational conditions change.
• Make routine operational and supervisory decisions within delegated authority without requiring prior approval from another manager.
• Monitor employee performance, productivity, quality, safety, and compliance.
• Provide coaching, direction, and immediate performance feedback as appropriate.
• Address routine employee performance, attendance, and conduct concerns consistent with company policies and applicable requirements.
• Exercise independent judgment in determining when employee matters require immediate intervention or escalation.
• Document employee performance or conduct concerns and recommend appropriate follow-up or corrective action to the employee's regular manager and Human Resources.
• Serve as the designated Operations management representative for the assigned area during the coverage period.
• Maintain accountability for the safe, timely, compliant, and effective operation of the assigned area.

Employee-management responsibilities apply only when the Operations Project Manager is formally designated to provide supervisor or manager coverage.

Quality and Safety

• Perform responsibilities in accordance with company policies, standard operating procedures (SOPs), Good Documentation Practices (GDP), Good Manufacturing Practices (GMP), and applicable regulatory requirements.
• Collaborate with Quality to ensure projects and operational improvements maintain regulatory compliance.
• Identify and address potential safety, quality, or compliance concerns within the scope of assigned authority.
• Stop or redirect work when an immediate safety, quality, or compliance concern exists.
• Support safety investigations, inspections, walkthroughs, and corrective actions.
• Promote a culture of safety, quality, accountability, and continuous improvement.

Qualifications

• Bachelor's degree in Operations, Business Administration, Supply Chain Management, Project Management, Life Sciences, or a related field preferred.
• Equivalent education and relevant professional experience may be considered.
• Five or more years of progressively responsible experience in operations, project management, warehousing, distribution, pharmaceutical, biotechnology, or another regulated environment preferred.
• Demonstrated experience independently managing projects from planning through completion.
• Experience developing project plans, tracking milestones, mitigating risks, and coordinating cross-functional initiatives.
• Experience evaluating and implementing operational process improvements.
• Previous experience providing supervisory or operational management coverage preferred.
• Experience in a GMP-regulated environment preferred.
• Strong organizational, analytical, communication, and problem-solving skills.
• Ability to exercise independent judgment and manage competing priorities with limited supervision.

Key Competencies

• End-to-End Project Management
• Independent Judgment and Decision-Making
• Operational Planning and Prioritization
• Risk Assessment and Mitigation
• Process and Workflow Optimization
• Cross-Functional Collaboration
• Problem Solving and Continuous Improvement
• Leadership and Accountability
• Effective Communication
• Regulatory Compliance and Audit Readiness
• Quality and Safety Focus

Core Values

Respect Integrity Collaboration Excellence

Other Duties

This job description describes the general nature and level of work performed and is not intended to represent an exhaustive list of all responsibilities. Additional duties may be assigned, and responsibilities may change based on operational and business needs.