Job Description
Job Description
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 it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to 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 customer-focused outlookBuilds 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 plansEducates and provides customer consultation on technical aspects of combination products and testing services, as appropriateManages, 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 exceededOversees day-to-day workload, priorities, and timelinesSets goals and provides career support, guidance, mentorship and developmentConducts regular 1 : 1 and staff sessions for cross-functional feedbackConducts performance reviews (as set by company policy)Performs site succession planningDemonstrates technical expertise to train and guide engineering / scientific staff on the development and execution of combination products testing servicesDrives internal cross-functional team (business development, quality, service operations) collaboration to discuss and resolve challenges with service projects, provide updates, and ensure execution to planParticipates in development and maintenance of the company's 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 appropriateIdentifies, builds, and maintains an external network of experts / companies to support capabilities development and deploymentAssists with site accreditations and renewals as neededParticipates, hosts, and conducts, internal, customer, and sub-contractor / supplier audits and visits, as neededManages the site budget and capital investments in conjunction with the Senior Leadership. Tracks and ensures operational efficiency and appropriate staffing of the siteSupports 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 productsDevelops content for technical support, services, and customer experience / journey, as well as represents ZebraSci at major scientific conferencesShares gathered intelligence and technical findings across ZebraSci team, Client network, and 3rd parties as appropriateKNOWLEDGE AND SKILLS :
Developed technological skills, including knowledge of drug-device 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 reportingKnowledge of small-scale filling and component assembly is desirableDeep understanding of design control and system integration is desirableWorking 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 oralAttention to detail with demonstrated ability to multi-task in a fast-paced environment, manage changing priorities, and communicate effectively across the organizationSophisticated project and time management skills; skilled in driving operationsAbility to delegate effectivelyEDUCATION 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 products10 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 experienceExperience working within a cGMP environmentExperience interacting with regulatory agencies and participating in or managing inspectionsFor certain roles at Client, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and / or required. Consistent with Client's 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. It's also a place where we help each other be great, we do what's 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, you'll 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 : NoVisa Candidate Considered : No
