The
Senior Manager, GMP Manufacturing Operations provides leadership for multi-shift GMP manufacturing operations supporting clinical and commercial cell and gene therapy programs at OmniaBio's Hamilton facility. Reporting to the Senior Director, Operations, the role is accountable for the safe, compliant, and efficient execution of manufacturing activities, with ownership of Manufacturing Safety, Quality, Delivery, Cost, and People (SQDCP) performance. Working closely with clients and cross-functional leaders, the Senior Manager leads Manufacturing Supervisors and oversees staffing, operational readiness, manufacturing performance, compliance, capacity planning, and continuous improvement initiatives to ensure successful delivery of client programs and commercial operations. This position serves as the operational counterpart to Technical Operations and may require support outside regular business hours to meet manufacturing and client commitments.
Responsibilities:Manufacturing Operations Leadership- Lead all routine GMP manufacturing activities supporting clinical and commercial manufacturing programs
- Accountable for Safety, Quality, Delivery, Cost, and People (SQDCP) performance across all GMP Manufacturing Operations
- Establish operational priorities and allocate resources to optimize manufacturing performance and capacity utilization to ensure manufacturing OTIF delivery
- Act as the senior operational escalation point for manufacturing execution issues and business-critical manufacturing decisions
- Drive a culture of accountability, operational excellence, and continuous improvement throughout the manufacturing organization
- Ensure manufacturing campaigns are executed safely, compliantly, and in accordance with approved procedures, schedules, and client commitments.
People Leadership & Organizational Development- Lead, coach, mentor, and develop Manufacturing Supervisors and associated manufacturing teams supporting multi-shift operations.
- Foster a high performing, collaborative, and accountable team culture by modeling company values and expected leadership behaviors
- Manage workforce planning, succession planning, talent development, performance management, employee engagement, and organizational capability development.
- Ensure appropriately trained, qualified, and competent resources are available to support current and future manufacturing activities.
- Support recruitment, onboarding, retention, and leadership development initiatives across the Manufacturing organization.
- Promote diversity, equity, inclusion, and belonging within the team.
Quality, Compliance & Manufacturing Documentation- Ensure all manufacturing activities are conducted in accordance with GMP regulations, approved procedures, and Good Documentation Practices.
- Ensure department provides required Support for Internal Service Level Agreements (SLA) for batch release and quality events
- Maintain manufacturing inspection readiness and support client, regulatory, and internal audits.
- Ensure Master Batch Records and manufacturing documentation appropriately support compliant and efficient manufacturing execution.
- Ensure executed batch records comply with ALCOA+ principles and documentation issues are escalated and resolved in a timely manner.
- Provide manufacturing leadership and resources for investigations, root cause analyses, CAPAs, and quality event management activities.
Manufacturing Facilities, Equipment & Operational Readiness- Ensure manufacturing equipment is available and maintained in a safe, compliant, and operationally ready state.
- Ensure classified manufacturing spaces remain in a controlled, clean, and inspection-ready condition suitable for GMP operations.
- Support operational readiness for new manufacturing suites, equipment, technologies, and manufacturing capabilities.
Planning, Capacity & Business Operations- Partner with Supply Chain, Scheduling, Program Management, Technical Operations, and other functional groups to ensure manufacturing capacity, resources, equipment, and materials align with business objectives and are clearly represented in S&OP activities.
- Support annual budgeting, operational planning, and manufacturing performance reporting.
- Ensure effective utilization of SAP and other systems supporting manufacturing execution and business operations.
Continuous Improvement & Operational Excellence- Drive implementation of the OmniaBio Operating Model (OBOM) and continuous improvement initiatives within manufacturing operations.
- Establish and monitor manufacturing KPIs including safety, quality, delivery, cost, productivity, training compliance, and batch performance.
- Lead initiatives that improve efficiency, reduce waste, enhance reliability, and support manufacturing scalability.
- Support deployment of digital manufacturing, automation, and operational excellence initiatives.
Client & Cross Functional Leadership- Serve as the operational manufacturing lead for active client programs and routine GMP manufacturing operations.
- Collaborate closely with Technical Operations, Quality, MSAT, Supply Chain, Facilities & Engineering, CQV, Program Management, and Finance to ensure successful manufacturing execution.
- Provide manufacturing leadership during client meetings, operational reviews, audits, and business planning activities.
- Support commercialization, scale-up, and strategic operational initiatives that support OmniaBio's growth objectives.
Qualifications and experience:- Bachelor's degree in related fields (life sciences or related engineering discipline)
- 12 years minimum of relevant manufacturing experience (GMP, cleanroom, biologics).
- Minimum 5 years of supervisory/leadership experience, with large multi-shift team
- Cell or gene therapy and/or CDMO experience required
- Direct experience with regulatory bodies
- Strong English written and verbal communication skills.
Desired Competencies and Behaviors:- Collaboration
- Integrity
- Resilience and Tenacity
- Teamwork
- Inter-personal awareness
- High energy
- Independence
- Influencing
- Leadership
- Organizational awareness
OmniaBio is a developing organization and represents a fluid working environment. Flexibility and adaptability are essential, and duties will be influenced by the needs of the organization.
Applicants must be legally eligible to work in Canada.
An applicant's compensation package is finalized once the interview process is concluded and accounts for the nature of the role as well as the experience, competencies (job knowledge, skills and abilities) of the applicant and internal equity.
