Site Services Director

Title: Site Services Director
Location: Temecula, CA
Job Type: Full Time/Permanent

Position Overview:
The Site Services Director is a leadership role responsible for overseeing all aspects of operations at the Temecula, CA site for combination product testing. This role involves contributing to the business strategy, advising on technical and scientific activities related to combination product development services, and ensuring efficient execution of customer projects in compliance with requirements. The Site Services Director will manage the site budget, make strategic investments, and lead the site staff in delivering exceptional service. This role will serve as the primary contact for pharmaceutical customers and oversee site visits and audits by customers or regulatory authorities.

Primary Duties and Responsibilities:

• Customer Engagement and Technical Expertise:
  
  • Serve as an expert in combination products, using technical knowledge to contribute to customer sales processes and service delivery.
  • Build strong relationships with customers, understanding their technical needs and translating these into actionable solutions, services, and plans.
  • Provide customer consultation on technical aspects of combination products and testing services.
• Leadership and Staff Management:
  
  • Supervise, onboard, and schedule customer projects, ensuring customer expectations are exceeded.
  • Oversee daily operations, including workload management, project priorities, and timelines.
  • Set clear goals and provide mentorship, career support, and regular performance reviews.
  • Develop site succession plans and maintain a highly motivated and skilled team.
  • Guide engineering/scientific staff on the development and execution of combination products testing services.
  • Foster collaboration with cross-functional teams (business development, quality, operations) to address service project challenges and ensure successful execution.
• Training and Compliance:
  
  • Participate in the development and maintenance of training programs in compliance with cGMP and/or ISO guidelines.
  • Train site staff on relevant technical and regulatory aspects related to combination products and testing services.
• Site Operations and Facilities Management:
  
  • Oversee all site maintenance, operating requirements, and investments for capability development.
  • Build and maintain an external network of experts and companies to support capabilities.
  • Support site accreditations and renewals as necessary.
  • Host and conduct internal, customer, and subcontractor audits and visits.
• Budget and Capital Management:
  
  • Manage the site budget and capital investments in coordination with senior leadership.
  • Track operational efficiency, ensuring appropriate staffing levels and resources.
• Business Development and Market Insights:
  
  • Support business development by scouting new trends in testing technologies and staying updated on regulations relevant to combination products.
  • Develop technical support materials and represent the company at scientific conferences.
  • Share intelligence and technical findings with internal teams, business development networks, and third parties.

Education and Experience:

• Education:
  • BS in a relevant science or engineering discipline (MS or PhD preferred).
• Experience:
  • 10+ years in a technological or operational role within the medical device, IVD, or pharmaceutical industry, with a focus on combination products.
  • People management experience, including overseeing teams and delivering projects.
  • Experience working in a cGMP environment.
  • Experience interacting with regulatory agencies and managing inspections is highly desirable.

Additional Qualifications:

• Strong leadership skills with the ability to motivate and guide a team.
• A customer-centric approach with a focus on providing innovative solutions to client needs.
• Proven ability to manage budgets and capital investments effectively.

Knowledge and Skills:

• Technical Expertise:
  
  • In-depth knowledge of drug-device combination products and medical devices.
  • Familiarity with mechanical measurement equipment (e.g., Instron, Zwick) and container closure integrity instrumentation.
  • Experience with method validation, test protocol generation, execution, and reporting.
  • Understanding of design control and system integration is desirable.
  • Knowledge of small-scale filling and component assembly is a plus.
• Regulatory Knowledge:
  
  • Working knowledge of industry standards such as cGMP.
  • Experience with regulatory agencies and managing inspections is preferred.
• Analytical Skills:
  
  • Proficient in statistical methods, including Design of Experiments, ANOVA, and statistical software (e.g., Minitab, JMP).
• Communication & Leadership:
  
  • Superior written and verbal communication skills.
  • Ability to manage multiple tasks in a fast-paced environment and prioritize effectively.
  • Strong project and time management skills with the ability to delegate tasks efficiently.