Site Services Director 3293770

Site Services Director

About the Company

Our client, an award-winning national leader in the medical technology industry, is dedicated to driving innovation and delivering exceptional healthcare solutions. They are committed to fostering a collaborative culture where excellence and professional growth are at the forefront.

Position Overview

The Site Services Director will lead operations for the Temecula site’s combination product development initiatives. This leadership role entails driving technical, scientific, and strategic efforts, maintaining operational efficiency, and ensuring compliance with regulatory requirements. You will oversee site investments, facilities maintenance, and budgets while serving as the primary contact for customer audits and regulatory visits.

Key Responsibilities

Customer Engagement & Relationship Building

• Serve as a subject matter expert in combination product testing.
• Provide technical consultations, translating client needs into actionable plans.
• Foster strong client partnerships by understanding goals and delivering tailored solutions.

Operational Oversight

• Manage onboarding and scheduling of customer projects to ensure seamless delivery.
• Oversee facilities maintenance and drive site investments for sustainable growth.
• Host and coordinate site audits conducted by regulatory authorities or external stakeholders.

Leadership & Development

• Mentor and guide site teams, fostering career development and collaboration.
• Conduct performance reviews, set measurable goals, and ensure compliance with cGMP and ISO guidelines.
• Lead knowledge-sharing programs and implement technical training initiatives.

Innovation & Technological Leadership

• Identify and implement emerging trends in combination product testing.
• Oversee the validation and execution of test methods, using tools like ANOVA and Design of Experiments.
• Represent the organization at scientific conferences, showcasing advancements and expertise.

Strategic Development

• Collaborate with cross-functional teams to address challenges and deliver successful project outcomes.
• Translate market insights into actionable operational strategies that drive business growth.

Required Skills and Expertise

Technical Expertise

• In-depth knowledge of combination products and mechanical measurement equipment (e.g., Instron, Zwick, and container closure integrity tools).
• Proficiency with statistical software (e.g., Minitab, JMP) and analysis methods (e.g., ANOVA).
• Experience with test protocol development, method validation, and technical reporting.

Industry Knowledge

• Strong understanding of cGMP standards and regulatory environments.
• Experience with small-scale filling and component assembly (preferred).
• Familiarity with design control and system integration (desirable).

Leadership & Communication

• Proven experience in team leadership and project management.
• Strong communication skills and attention to detail, particularly in fast-paced environments.

Education & Experience

• Bachelor’s degree in science or engineering (required); advanced degrees (MS or PhD) are preferred.
• At least 10 years of experience in the medical device or pharmaceutical industry, with a focus on combination products.
• Demonstrated success in cGMP-regulated environments and regulatory inspections.

Benefits

• Comprehensive health and wellness programs.
• Opportunities for professional development and career advancement.
• Collaborative and innovative work environment.
• Paid time off and access to employee assistance programs.

Additional Information

Resumes will be handled with strict confidentiality. If your qualifications align with the role, you will be promptly contacted to discuss next steps.

Job Type: Full-time

Pay: Up to $190,000.24 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Health insurance
• Life insurance
• Paid time off
• Professional development assistance
• Vision insurance

Schedule:

• Night shift

Application Question(s):

• 3293770 What type of compensation is desired for a new position?

Education:

• Bachelor's (Required)

Experience:

• Recent Site Services Director: 1 year (Required)
• Recent Medical or pharmaceutical combo products: 10 years (Required)
• Recent cGMP environments: 1 year (Required)
• Recent Interacting with regulatory agencies: 1 year (Required)
• Recent People management: 1 year (Required)
• Recent Design control, system integration: 1 year (Required)
• Recent Statistical tools (e.g., DOE, ANOVA, Minitab): 1 year (Required)

Ability to Commute:

• Temecula, CA (Required)

Ability to Relocate:

• Temecula, CA: Relocate before starting work (Required)

Work Location: In person

Salary : $190,000