Thermo Fisher Scientific Instrument Compliance, Product Manager in Carlsbad, California
When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.
This role is remote based (anywhere in the U.S.); however up to 50% travel is required throughout the U.S., Canada, and Europe as needed.
How will you make an impact?
This position is responsible for developing and managing our service delivery strategy and growth initiatives in support of expanding our remote monitoring and cGMP compliance based services. With initial focus in NAm and eventual expansion to EMEA/APAC, the Lab Instrument Compliance, Product Manager works hand in hand with regional marketing and commercial teams to identify and refine the corresponding portfolio offering, and drive business development and pipeline management processes needed to achieve/exceed AOP growth targets. They will also partner with the field service delivery management teams in each geo to optimize the required go-to market model, ensuring FSE capability and capacity to support growth demands and drive service product delivery efficiency.
What will you do?
Develops and manages service delivery growth strategy and execution activities needed from marketing, sales, and service delivery teams to achieve AOP growth targets.
Supports the IES geo VPs of Service Delivery in setting annual business goals and budgets.
Works with IES business on STRAP inputs needed to accelerate growth within the Lab Instrument Compliance services product Line.
Conduct gap analysis on current remote monitoring and valiadation offerings encompassing product, compliance, people, processes and technology/tools, across the IES regions (NAm, EMEA APAC)
Leads service product development and execution activities supporting remote monitoring and validation services growth globally.
Works with LPD Field Service Strategy Director, IES and LPD/BU marketing teams and Thermo Fisher Instrument Health COE to determine portfolio of viable service offerings, positioning and pricing.
Works with IES and LPD/BU commercial teams and Instrument Health COE to establish pipeline management process driving new business opppotunity volume and dramatically increasing lead to win ratio.
Works with Field Service delivery management to coordinate product delivery competencies, project/customer prioritization, prepare workload forecasts, review team utilization/capacity, and identify productivity improvement opportunities tied to coverage model and/or service product delivery activities.
Drives continuous process improvement.
Simplifies, standardizes and ensures process optimization for Lab Instrument Compliance Product Offering, utilizing PPI business system and tools.
Collarobate with with Corporate/ULS IT, ULS COE (Regulatory) and others to identify and deploy scalable technology to support the ISP operating model.
Follows Thermo Fisher Scientific business ,and client standards requirements, overall good industry practices for Commissioning/Qualification/Validation (C/Q/V) services and all regulatory requirements.
Works with Quality & Regulatory teams to develop and apply quality/regulatory validation practices for all project deliverables and business practices (i.e. ISO 9001, ISO 13485, ISO 17025, FDA 820 etc.). In conjunction with Quality, performs project audits to ensure all project goals are being met and compliance services are offered as a value added product to TFS clients.
Develops and maintains “industry presence” and personal network to develop opportunities.
Maintains a high level of professionalism in validation/compliance and encourages networking, peer presentations and involvement of self and staff in networking and educational programs.
How will you get here?
- BA or BS degree, Master’s degree or higher preferred
Minimum of seven years service marketing, field management and/or compliance management system industry experience, with focus in field service delivery product and program management
Minimum of 5 years of experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation or QA. Possesses solid understanding how biopharma/CRO/MRO regulated labs work and the various laboratories compliance concerns.
General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical Design/Build/Commission/Validate processes and how they relate to regulatory requirements and GMP regulations within the E.U. and U.S. FDA.
Knowledge, Skills, and Abilities:
Basic understanding of calibration and qualification practices, GxP/17025, and the writing and execution of IQ, OQ and PQ protocols for GMP Utilities, Equipment, Systems and Software.
Ability to interact and understand procurement, IT, and quality requirements as they relate to compliance.
Proficiency with Microsoft Office applications (Word, Excel, Project, PowerPoint, etc.).
Strong team player with ability to develop effective working relationships across organization: divisional, regional and global marketing teams, sales, field service devliery, operations and IT
Ability to analyze situations, apply independent judgment, discretion and initiative to address problems and develop practical, thorough and creative solutions
Experience of working within, influencing within, and networking within a matrix environment.
At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
Apply today! http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.