Site Services Director

Position: Site Services Director

Location: Temecula California United States

Job Description

• This position is reporting to the Director of Combination Products and Technical Services.
• As part of the ZebraSci Leadership Team the Site Services Director is responsible for contributing to the business strategy directing site technical and scientific activities related to combination product development services leading all aspects of the Temecula CA site operations for combination product testing and ensuring that customer projects are executed efficiently in compliance with requirements and with a positive customer experience. S/he will be responsible for managing the site budget making appropriate investments and leading the site staff responsible for service delivery. The Site Services Director will serve as a primary contact for pharmaceutical customers and a main point of contact for site visits and audits by customers or regulatory authorities.

We are the makers of possible

• Client is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose and its no small feat. It takes the imagination and passion of all of usfrom design and engineering to the manufacturing and marketing of our billions of MedTech products per yearto look at the impossible and find transformative solutions that turn dreams into possibilities.
• This position is reporting to the Director of Combination Products and Technical Services.
• As part of the ZebraSci Leadership Team the Site Services Director is responsible for contributing to the business strategy advising site technical and scientific activities related to combination product development services leading all aspects of the Temecula CA site operations for combination product testing and ensuring that customer projects are executed efficiently in compliance with requirements and with a positive customer experience. They will be responsible for managing the site budget making appropriate investments and leading the site staff responsible for service delivery. The Site Services Director will serve as a primary contact for pharmaceutical customers and a main point of contact for site visits and audits by customers or regulatory authorities.

PRIMARY DUTIES RESPONSIBILITIES & AUTHORITIES:

Serves as a combination products expert and leads customer engagement:

• Uses technical expertise to contribute to the customer sales process and services delivery while maintaining a customerfocused outlook
• Builds strong working relationships with customers to understand on a deep level the technical needs and issues and translates these into appropriate responses solutions services and executable action plans
• Educates and provides customer consultation on technical aspects of combination products and testing services as appropriate

Manages develops and drives the Temecula CA staff including:

• Supervises the onboarding scheduling and delivery of new customers and customer projects while ensuring customer expectations are exceeded
• Oversees daytoday workload priorities and timelines
• Sets goals and provides career support guidance mentorship and development
• Conducts regular 1:1 and staff sessions for crossfunctional feedback
• Conducts performance reviews (as set by company policy)
• Performs site succession planning
• Demonstrates technical expertise to train and guide engineering/scientific staff on the development and execution of combination products testing services
• Drives internal crossfunctional team (business development quality service operations) collaboration to discuss and resolve challenges with service projects provide updates and ensure execution to plan
• Participates in development and maintenance of the companys training programs in compliance to cGMP and/or ISO guidelines.

Responsible for site maintenance operating requirements investments and capabilities development:

• Responsible for leading all facilities work leveraging site staff as appropriate
• Identifies builds and maintains an external network of experts/companies to support capabilities development and deployment
• Assists with site accreditations and renewals as needed
• Participates hosts and conducts internal customer and subcontractor / supplier audits and visits as needed
• Manages the site budget and capital investments in conjunction with the Senior Leadership. Tracks and ensures operational efficiency and appropriate staffing of the site

Supports business development and captures and translates market insights to drive the business:

• Ensures site Technology Development team scouts new testing technology trends and stays abreast of changing regulations standards and environment relevant to combination products
• Develops content for technical support services and customer experience/journey as well as represents ZebraSci at major scientific conferences
• Shares gathered intelligence and technical findings across ZebraSci team Client network and 3rd parties as appropriate

KNOWLEDGE AND SKILLS:

• Developed technological skills including knowledge of drugdevice combination products and/or medical devices including market available technologies from major industry suppliers knowledge of the operation of mechanical measurement equipment (e.g. Instron Zwick etc.) and container closure integrity instrumentation and experience with method validation and test protocol generation execution and reporting
• Knowledge of smallscale filling and component assembly is desirable
• Deep understanding of design control and system integration is desirable
• Working knowledge of industry standards and requirements (ex. cGMP)
• Application of statistical and analytical methods such as Design of Experiments ANOVA analysis and statistical software (Minitab Jump etc.)
• Superior communication skills both written and oral
• Attention to detail with demonstrated ability to multitask in a fastpaced environment manage changing priorities and communicate effectively across the organization
• Sophisticated project and time management skills; skilled in driving operations
• Ability to delegate effectively

EDUCATION AND EXPERIENCE:

• BS (MS or PhD degree preferred in a science or engineering discipline) plus proven experience in medical device IVD and/or pharmaceutical industry working with combination products
• 10 years working in a technological or operational role within medical devices and/or pharma combination products with a BS (8 for MS 6 for PhD)
• People management experience
• Experience working within a cGMP environment
• Experience interacting with regulatory agencies and participating in or managing inspections

For certain roles at Client employment is contingent upon the Companys receipt of sufficient proof that you are fully vaccinated against COVID19. In some locations testing for COVID19 may be available and/or required. Consistent with Clients Workplace Accommodations Policy requests for accommodation will be considered pursuant to applicable law.

Why Join Us

• A career at Client means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. Its also a place where we help each other be great we do whats right we hold each other accountable and learn and improve every day.
• To find purpose in the possibilities we need people who can see the bigger picture who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At Client youll discover a culture in which you can learn grow and thrive. And find satisfaction in doing your part to make the world a better place.
• Client is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race color religion age sex creed national origin ancestry citizenship status marital or domestic or civil union status familial status affectional or sexual orientation gender identity or expression genetics disability military eligibility or veteran status or any other protected status.
• For additional details regarding submission eligibility and payment terms please refer to your contract. Only submissions from agencies with current service contracts in place will be considered.
• Security Clearance Required: No
• Visa Candidate Considered: No