Thermo Fisher Scientific Job - 31455148 | CareerArc
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Company: Thermo Fisher Scientific
Location: Carlsbad, CA
Career Level: Mid-Senior Level
Industries: Healthcare, Pharmaceutical, Biotech


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.

>$1 Billion in Revenue: The role is responsible for quality within the Cell Biology business unit and has broad multi-site responsibility across 15 manufacturing sites led by 5 of the 6 LSG Divisions (BID, BPD, LPD, CSD, GSD) and the China region. This role is responsible for Quality in Cell Biology Segment and full responsibility for Carlsbad and Madison Quality Management Systems.
This position is responsible for quality in Carlsbad and responsible for complaint incidents on all other sites manufacturing product for the BU.: e.g., Grand Island, Inchinnan, Roskilde, Suzhou, and Rochester.

Cell Biology represents ~33% of BID's revenue (~$3b) and is expected to grow at ~10% rate. This role has a direct influence in customer experience and support revenue growth and revenue protection by building a strong Quality Management System for the Business Unit.

How will you make an Impact?

This role supervises Professionals (Staff Quality Engineers) and Site Quality Managers. The role's responsibilities expand beyond operations and manufacturing. The role is part of BU VP/GM extended leadership team and is closely involved in strategic initiatives for the BU.

What will you do?

  • Quality Management Representative for Carlsbad Site
  • Responsible for managing internal audit system and external audits.
  • Responsible for maintaining ISO 9001 certification
  • Responsible for Managing all ISO 9001 Quality System Elements, e.g., Complaint Handling, CAPA, Change Control, Validation
  • Lead Complaint Reduction Initiative for Carlsbad
  • Lead Document Control Function in Carlsbad

Cell Biology Quality Leader Responsibilities:
Single point of Contact for Cell Biology Business Unit: Responsible for post market surveillance and complaint analysis for Cell Biology Business Unit Portfolio, tactical follow up on key customer facing issues: logistics, order processing and technical complaints. Ensure effective closure of key complaint cases. Follow up and ensure closure of compliance gaps across Business Unit quality systems for all sites manufacturing product for BU. Serves the PAC Quality Representative function for Cell Biology Portfolio NPIs.
Quality System Improvement driver: Drive best practice sharing and implementation of key improvements for all sites manufacturing product for BU. Drives a common Quality Strategy across BU portfolio: e.g., Business Unit level change control system (CCB), SOP harmonization, QC harmonization across common products etc. Uses PPI (continuous improvement tools) to promote and lead BU Quality System improvements. In particular, this leader would be responsible for ensuring the Cell & Gene Therapy (CTS) products meet the appropriate quality standards across all sites.
Leverage Global Quality resources: Connects Business Unit with global quality teams and resources, e.g. link with Design Quality team, link with Supplier quality team, link with Global Quality Systems, clinical regulatory team, product compliance, etc. For example, this leader could play a role in connecting with the China trade compliance team regarding challenges with importation of products.

Responsibility covers tactical quality incident management as well as leading and supporting strategic initiatives for BU. Responsibility expands beyond operations and manufacturing and this role interacts with and drives improvements across divisions and sites to support BU objectives. Goal is to become a strategic partner for the BU and leverage global resources to support BU objectives. The role covers quality responsibility in Product Development stages all the way to service, support and post market surveillance.
Part of BID Quality's strategy is to expand the influence of Quality beyond operations. New Product Development, Quality by Design principles are all functions outside of operations which have a very high impact in product quality and customer experience.

How will you get there?
The role requires a deep Quality Management System knowledge, Quality Management for a Life Sciences business, Regulated Quality Systems and a strong business acumen.
7+ years of related experience within quality management and quality systems preferred.
Bachelor's degree of science or engineering required.

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!

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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