Job Title: Supervisor, Quality Systems

Requisition ID:

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.

Location/Division Specific Information

West Hills, CA / Transplant Diagnostics division of Thermo Fisher Scientific

How will you make an impact?

The Supervisor, Quality systems will be responsible for maintaining appropriate licensing, marketing and legal compliance of all appropriate medical device products in order to control the safety and efficacy of our products. You will work closely with the Divisional and Group Regulatory teams to define and execute on the optimal regulatory submissions and approval pathway, through discussions with R&D, Marketing, Manufacturing and external regulatory agencies. Have a deep understanding of the US Food and Drug Administration (FDA) and European medicines Agency (IVDD/CE, JPAL, SFDA) regulatory processes and expectations.

What will you do?

• Ensure Transplant Diagnostics products comply with the regulations of all applicable regulatory agencies.
• 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 ASR vs. CLIA vs. EU vs. FDA based approaches and timeline and reimbursement ramifications.
• Provide exceptional leadership, mentorship and people development to the Company Regulatory and Quality organization.
• Further establish a culture in which people development, recruitment and retention are a priority.
• Support submissions of license variations and renewals.
• Monitor and set timelines for license variations and renewal approvals.
• Work with Marketing to approve commercial literature and language.
• Work with R&D teams to plan and develop product trials and interpret trial data.
• Advise scientists and manufacturing teams on regulatory requirements.
• Work with 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.
• Approve storage, labeling and packaging requirements.
• 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.
• Work on extremely complex problems where analysis of situations or data requires an evaluation of intangible, variable factors.
• Support 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).
• 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.
• Establish and manage effective employee training programs related to GMP, PCO, ISO regulatory requirements, EH&S related requirements, and NCAR and CAPA management.
• Provide leadership for the regulatory function and coordinate activities directed toward obtaining marketing clearance for all diagnostic products.
• Maintain company activities in compliance with Quality System Regulations (cGMP), ISO 9001, ISO 13485 and CMDR Regulations.
• Ensure Quality Systems are effectively maintained to achieve strong levels of GMP/ISO compliance.
• Lead Quality, Regulatory and Compliance teams.

How will you get here?

• Bachelor degree in a biological or related science from an accredited college or university plus four (4) years of Regulatory Affairs/Quality Assurance relevant experience
• OR Master’s degree in a biological science from an accredited college or university and a minimum of two (2) years of Regulatory Affairs/Quality Assurance relevant experience.

Knowledge, Skills, Abilities

• Minimum of 2 years management experience preferred
• Knowledge of and experience with all FDA regulatory requirements concerning class I, II, and II devices including: design control, validations, MDRs, 510(k) submissions (PMNs), PMAs, IDEs and other pertinent issues.
• Extensive knowledge of QSR/QMS to support CGMP, GLP, IVDD, ISO-9001, EN46001, ISO-13485, CMDCAS, compliance/processes, CE Marks, statistical tools, and audits.
• Familiar with Environmental and Occupational Safety and Health principals as well as rules and regulations of governmental agencies, such as CAL-OSHA and EPA.
• Familiar with manufacturing techniques, project management and formal continuous process improvement techniques (lean manufacturing)
• Diagnostics industry experience is required
• Knowledgeable of the relevant aspects of the law

At Thermo Fisher Scientific, each one of our 70,000 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.