Description
**Commissioning & Qualification (C&Q) Lead (Level 6) – Manager, C & Q Center of Excellence (CoE)**
**Summary:**
The **C&Q CoE Lead** provides leadership and strategic direction for the Commissioning and Qualification (C&Q) activities within the broader manufacturing operations network. This role manages a small, high-performing team responsible for delivering C&Q documentation, test protocols, and execution summary reports and other C&Q lifecycle documents to ensure facility, utility, and equipment systems are fit for intended use and compliant with internal standards and regulatory expectations. The C&Q Program Lead drives standardization, efficiency, and continuous improvement in C&Q processes across projects and manufacturing functions.
**Key Responsibilities:**
**Leadership & Team Management**
+ Manage a team of C&Q engineers and specialists responsible for authoring, reviewing, and commissioning and qualification lifecycle documentation.
+ Set clear expectations, provide mentorship, and foster a culture of accountability, technical excellence, and collaboration.
+ Coordinate workload and resource allocation across multiple project workstreams to ensure timely delivery of C&Q milestones.
+ Support career development, training, and performance evaluations for direct reports. **Program Oversight & Delivery**
+ Serve as the primary C&Q representative to the Capital project leadership team, ensuring alignment of C&Q strategy, and prioritization with project goals, quality standards, and business needs.
+ Lead development and execution of the overall C&Q plan, including scope definition, risk assessment, protocol strategy, and system prioritization.
+ Oversee generation, review, and approval of C&Q documents such as User Requirements Specifications (URS), commissioning plans, qualification protocols (IQ/OQ/PQ), and summary reports.
+ Manage C&Q schedule, budget, and resource forecasting; identify risks and implement mitigation plans proactively.
+ Ensure adherence to applicable global standards, Good Manufacturing Practice (GMP) regulations, and data integrity requirements. **Process Standardization & Continuous Improvement**
+ Champion the implementation and maintenance of standardized C&Q practices, templates, and procedures across sites and projects.
+ Drive process improvements to enhance efficiency, consistency, and compliance in C&Q execution.
+ Collaborate with cross-functional partners (Engineering, Validation, Quality, Operations, and Global Facilities Delivery) to align on best practices and lessons learned.
+ Contribute to global C&Q governance initiatives and knowledge-sharing forums. **Stakeholder Engagement & Communication**
+ Act as the interface between the site C&Q teams, project management, and quality assurance functions.
+ Communicate progress, risks, and key decisions to stakeholders through clear reporting and status updates.
+ Support quality reviews by providing subject matter expertise and ensuring documentation readiness. **Qualifications:** **Basic Qualifications**
+ Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
+ 7+ years of experience in commissioning, qualification, or validation in a GMP-regulated environment.
+ Demonstrated leadership experience, including direct people management or technical team leadership. **Preferred Qualifications**
+ Master’s degree in Engineering or related discipline.
+ Experience leading C&Q activities for large-scale capital projects (biotech, pharmaceutical, or sterile manufacturing preferred).
+ Strong understanding of ASTM E2500, ISPE Baseline Guides, GAMP principles, and FDA/EMA regulatory expectations.
+ Proven track record of implementing process improvements and standardization initiatives.
+ Excellent organizational, communication, and stakeholder management skills.
+ Ability to work effectively in a matrixed, cross-functional, and fast-paced environment. **Competencies:**
+ Strategic Thinking and Decision-Making
+ Technical Expertise in C&Q and Validation Science
+ Leadership and Talent Development
+ Continuous Improvement and Innovation
+ Collaboration and Influence
+ Project Management and Execution Excellence
