Site Director (cGMP)

Company Description:

Caligor Coghlan (CalCog) is a vertically integrated clinical supply services company that provides sourcing, packaging, labeling, storage, and distribution services for early to late phase global clinical trials. We pride ourselves in making it our business to find a better way to deliver for our clients and the patients they serve. Our dedicated people care - about their work, their team, and the results we strive to deliver every day.

If you are looking for a role that supports the types of endeavors listed above in the world of drug supply services, where what you do and how you do it will make a difference, then this position is for you.

Job Summary:

The Site Director will be responsible for the overall management, processes, and compliance of CalCog’s facility in alignment with cGMP (Current Good Manufacturing Practice) standards. This role focuses on the maintenance and optimization of the facility infrastructure, ensuring the environment meets regulatory requirements for cleanliness, safety, and operational effectiveness. The Site Director will lead facility teams, drive strategic initiatives for continuous improvement, and ensure that the site passes all regulatory inspections and audits.

Key Responsibilities:

• Facility Operations Leadership: Oversee and manage all aspects of facility operations, including HVAC systems, production rooms, utilities, waste management, and environmental controls, to ensure compliance with cGMP requirements. Lead efforts to develop disaster recovery and business continuity plans for facility-related contingencies.
• Capital Projects and AOP Management: Manage the facility OpEx budget, tracking expenses for utilities, maintenance, capital improvements, and other facility-related costs. Drive cost-effective strategies while maintaining high operational standards. Lead facility upgrades and new capability introduction projects, ensuring they align with business needs, regulatory requirements, and quality standards. Oversee the selection and installation of equipment and systems to support facility operations.
• Process Excellence: Lead continuous improvement initiatives, utilizing Six Sigma (or other methodologies) to enhance productivity. Establish and monitor key performance indicators (KPIs) for efficiency, quality, and regulatory compliance.
• Facility Maintenance: Ensure ongoing preventive maintenance, equipment calibration, and timely repairs of all facility infrastructure, including utilities, production areas, and support systems, ensuring minimal downtime and optimal performance.
• Regulatory Compliance: Ensure all facility operations meet or exceed cGMP, FDA, DEA, and other regulatory standards. Prepare the site for inspections and audits facilitating corrective actions as necessary. Act in the capacity of Responsible Person for facility licenses and registrations (i.e. DEA registrations, State of Texas licenses, etc.).
• Quality and Safety Management: Ensure the facility maintains a safe and clean environment through the implementation of robust safety programs.
• Collaboration with Cross-Functional Teams: Work closely with Warehouse, Production, Quality, Client Services, Finance and Commercial teams to ensure the facility optimization. Act as the liaison with offsite senior leadership to facilitate the flow of updates and ensure transparency with issues impacting the company and client projects.
• Vendor and Contractor Management: Oversee the selection and management of external vendors, contractors, and service providers who impact the CalCog’s cGMP facility to ensure compliance with contractual agreements and operational efficiency.
• Training and Development: Lead training efforts for facility staff on cGMP practices, safety protocols, and facility-specific procedures to ensure a knowledgeable, compliant, and high-performing team.

Qualifications:

• Bachelor’s degree in Engineering, Facilities Management, Life Sciences, or a related field.
• At least 5 years of experience in facility management within a cGMP-regulated manufacturing environment.
• Strong knowledge of cGMP, FDA, ISO, OSHA, and other regulatory guidelines.
• Proven experience with process improvement methodologies (Lean, Six Sigma, Kaizen, etc.).
• Proven track record of managing capital projects, facility maintenance, and upgrades.
• In-depth knowledge of facility systems, including HVAC, production rooms, and utilities.
• Strong leadership and people management skills, with the ability to foster a culture of compliance and continuous improvement.
• Excellent problem-solving, project management, and budgeting skills with an ability to lead through change and manage complex operational challenges.
• Ability to work in a fast-paced, highly regulated environment while managing multiple priorities.

Preferred Qualifications:

• Advanced degree in Facilities Management, Engineering, or related field.
• Professional certification in Facilities Management (i.e. IFMA).
• Certification in project management (i.e. PMP).
• Facility operations management in a pharmaceutical, biotechnology, or similar regulated manufacturing environment.