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Job ID :
38345BR
Location :
US - California - Fremont
:
Job Description

Responsibilities:

  • Oversee a high performing Quality, Regulatory and Compliance team by hiring and developing strong managers, establishing and actively managing performance expectations, and providing development opportunities to staff.
  • Develop and communicate a Quality and Regulatory vision and strategic objectives that align with the operations and business strategy.
  • Coach, motivate, and communicate to a mix of RUO (ISO 9001), CE-IVD (13485), and cGMP (21CFR820) Quality Assurance teams.
  • Create coherent and unified global regulatory strategies through the facilitation and coordination of team meetings, representation of Global Regulatory Affairs and provision of regulatory expertise.
  • Ensure regulatory strategies throughout lifecycle of products as appropriate. Refines regulatory strategies as needed and ensures strategy is in alignment with Niche Diagnostics portfolio and regional strategies.
  • Assure timely, accurate and efficient management of Quality Assurance operation, including accurate document controls, and up-to-date revision controls for product manufacturing, testing and releasing procedures, as well as product labeling and package inserts
  • Oversee Quality Control team performance to meet standard turnaround times, reduce the cost of poor quality, and improve the compliance to the site Quality Management System.
  • Ensure effective management of the Quality Management System including assuring effective management reviews, complaint handling, CAPA system, change control, calibration maintenance, process validation, internal auditing, R&D transfers, and manufacturing area support.
  • Ensure Niche Diagnostics’ products comply with the regulations of all applicable regulatory agencies
  • Maintain company activities in compliance with Quality System Regulations (cGMP), CE-IVD,ISO 9001, ISO 13485 and other appropriate regulations
  • Ensure Quality Systems are effectively maintained to achieve strong levels of cGMP/ISO compliance
  • Stay current and apprised of changing international legislation, guidelines and customer practices
  • Develop and write clear processes for regulatory approvals, working with commercial teams to define appropriate RuO, ASR, IVD - based approaches and timeline, including understand of the reimbursement ramifications.
  • Work with Marketing to approve commercial literature and language.
  • Work with Divisional/Group R&D teams to plan and develop product trials and interpret trial data
  • Advise scientists and manufacturing teams on regulatory requirements.
  • Work with Divisional/Corporate teams and our Legal department to undertake and manage regulatory inspections and recalls.
  • Review company practices and provide advice on changes to systems.
  • Liaise with and make presentations to regulatory authorities.
  • Develop, implement, and improve quality programs to meet worldwide standards for efficacy, safety and quality.
  • Develop strategies to obtain appropriate regulatory clearances and assess the type and amount of product performance data required to ensure product approval.
  • Act as a liaison and interact with all regulatory agencies and auditors from OEM customers on matters related to quality system management.
  • Coordinate and manage all corrective actions including audit findings, customer complaints, non-conformance action (NCAR) and corrective and preventative action (CAPA).
  • Establish and manage effective employee training programs related to GMP, PCO, ISO regulatory requirements, EH&S related requirements, and NCAR and CAPA management.
  • Represent the business unit on the Thermo Fisher Scientific QARA Council.

The above statements are intended to describe the general nature and level of the work being performed by people assigned to this job. They are not an exhaustive list of all of the duties and responsibilities associated with it.

Minimum Qualifications:

  • Bachelor’s Degree in Chemistry, Life Sciences, Applied Medical, or related field of study. An advanced degree (MS, PhD, MD or Pharm D) is preferred.
  • Minimum of 10 years of experience in a highly regulated environment, such as diagnostics, pharmaceutical, biotechnology, or medical device, with at least 6 years of Regulatory Affairs, Compliance, and/or Quality experience. Previous clinical lab experience is preferred.
  • Minimum of 10 years of experience in a supervisory capacity or managing teams within matrix environment is required.
  • Knowledge of and experience with all FDA regulatory requirements concerning class I, II, and III devices including: design control, validations, MDRs, 510(k) submissions (PMNs), PMAs, IDEs, INDs, NDAs, and other pertinent issues.
  • Extensive knowledge of QSR/QMS to support cGMP, GLP, CE-IVD, ISO-9001, EN46001, ISO-13485,CMDCAS Etc.
  • Experience developing both domestic and international regulatory strategies and an understanding of product development.
  • Familiar with manufacturing techniques, project management and formal continuous process improvement techniques (Lean Manufacturing).
  • Ability to closely partner with customers to adapt the management system and manufacturing methods to meet requirements while ensuring regulatory compliance.
  • Demonstrated ability to use continuous improvement skills and tools to prioritize and drive projects and improvements/standardization to improve Quality service levels, reduce costs, and align with strategic objectives.
  • Significant knowledge and insight into qualification and validation activities and the ability to partner effectively with engineering and operations teams in completing these tasks.
  • Knowledge of labeling requirements, systems and processes.
  • Demonstrated flexibility and an ability to manage multiple complex projects simultaneously.
  • A strong team player, able to partner effectively with other functional leaders.
  • Inspirational leadership skills that will help promote and maintain a strong quality culture.



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.
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