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ThermoFisher Scientific Sr Manager, Quality, Production Support in Lenexa, Kansas

Job Description

Job Title: Sr Quality Manager

Reports To: Director, QARA

Group/Division: SDG/Microbiology

Career Band & Track: 8, Management Track

Job Family: QAS

Location: Lenexa, KS

Day/Shift: Day: N/A

Position Summary:

Provide leadership and management for quality activities at the MBD Lenexa, Kansas manufacturing site to ensure that quality assurance, validation and quality engineering activities are effective, efficient and in compliance with regulatory expectations and quality standards.

Day to day interactions are with the site’s value stream managers, however for all overall quality policies, quality systems processes and key quality objectives the position reports directly into the Director, Quality Assurance & Regulatory Affairs.

Key Responsibilities:

  • Drive, champion and promote quality practices and behaviors across the site.

  • Responsible for compliance to regulatory requirements including Quality Management Systems standards i.e. ISO 9001, ISO 13485, ISO 17034, MDSAP, FDA, and the In Vitro Diagnostics Regulation (IVDR).

  • Drive continuous improvement through PPI to deliver improved performance from a quality, service and cost point of view.

  • Responsible for the release of product to external and internal acceptance criteria.

  • Lead and develop staff within the function to a high level of proficiency and performance. Do this by setting clear, comprehensive expectations; demonstrate role model leadership; provide meaningful, timely feedback about performance; train and coach to continuously improve individual performance and business results.

  • Prepare and monitor site quality objectives and provide quality insight and technical expertise to the site Operations Leadership Team.

  • Prepare the site for, and support, external audits (customer/regulatory) ensuring corrective/preventative actions are appropriate to address non-conformances.

  • Manage the fundamental quality system process to ensure compliance, timeliness and effectiveness e.g. CAPA, change control, etc.

  • Provide oversite for the Quality Assurance team drive timely review of all customer complaints and ensure appropriate movement through the vigilance process where required, including notification of reportable events to regulatory authorities.

  • Ensure that validation system is follows relevant external (regulatory) requirements including ISO and IVDD/IVDR.

  • Lead the quality engineering team ensuring partnership with the Operations teams on production issues, training and SOP compliance, root cause analysis, CAPA implementation and other Quality related matters.

  • Supports, adopts and promotes the Thermo Fisher 4 I valves – Integrity, Intensity, Innovation and Involvement.

  • Accountable for headcount and fiscal budgets of the QA department.

Minimum Requirements/Qualifications:

  • Minimum two years of leadership experience in a Quality function

  • Minimum five years of proven experience working in Quality Assurance within a regulated environment such as medical device or equivalent.

  • Degree in Biology or other technical field

  • Excellent verbal, written and interpersonal communication.

  • Strong leadership skills with the ability to challenge, influence, and build consensus.

  • Knowledge of regulatory requirements including ISO 13485, 9001, 17034, 17025, FDA, and the IVD Regulation.

  • Ability to prioritize multiple tasks and functions optimally in a global, multi-site

  • Experience in microbiology preferred

Non-Negotiable Hiring Criteria:

  • Experience in Quality Assurance in a FDA regulated industry.

  • Leadership experience.

  • Degree in a Biological Science or QA field.

Thermo Fisher Scientific is an Equal Employment Opportunity and Affirmative Action Employer

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.