Sr Director, Quality - Salt Lake City, United States - bioMérieux SA

Description

The Salt Lake City Sr.

Director of Quality has responsibility for developing, implementing, maintaining, and continually improving the bioMerieux, BioFire Diagnostic Salt Lake City Site Quality Management System (QMS) to ensure customer requirements are implemented into company products and services provided, and ensuring operational compliance with government regulations and applicable standards.

Responsible for the organization, staff development, lead and develop the operations of the Quality Department.
The Sr. Director Quality is a Top Management level position that reports with a solid line to the VP of Quality for Americas Manufacturing, Global Supply Chain and Product Labeling and Documentation, and a dotted line relationship to the Site Head (i.e. Senior Vice President of BioFire Site Operations) in Salt Lake City.
The Sr.

Director of Quality acts as the BioFire Quality Management Representative (QMR), and site Quality Person Responsible for Regulatory Compliance (EU-IVDR PRRC), specifically overseeing QMS compliance, Manufacturing and Product release controls for all manufacturing sites in SLC.

Primary Duties

• Perform all work in compliance with company quality procedures and standards, and in close collaboration with Top Management, department directors and peers.
• Develop and maintain strong working and collaborative relationships within local Leadership, QMR's, and

Global Quality Board members across bioMerieux.

• Governance and execution of the BioFire Diagnostics Quality Policy, and distribution of the company

Quality Objectives.

• Ensure that QMS requirements are effectively established and maintained with applicable U.S. and international regulations.
• Ensure the promotion and awareness of applicable regulatory requirements and QMS requirements throughout the organization.
• Lead Management Reviews and ensure delivery of summary report to all members of Top Management for review, improvement recommendations, and establishment of Quality Objectives.
• Align site objectives to corporate/global needs and expectations, and ensure objectives are met.
• Own the Top Management Training Group and ensure proper training assignments are maintained for all

members related to Top Management activities; sign off on training for Top Management as needed.

• Develop, design and document quality structures, processes and procedures based on BioFire business needs and understanding of quality practices.
• Participate in Change Control, Field Action Board, Senior Leadership, Quarterly/Annual Operation Reviews, Management Review, and Vigilance Reviews as applicable
• Fulfill Manufacturing Quality PRRC duties as defined.
• Implement changes needed to maintain QMS compliance with regulations and bioMerieux Global Processes.
• Determine strategies to meet FDA, MDSAP, IVDR, ISO and other international Quality requirements. Understand risks and implementing mitigations for customer and business needs.
• Prepare and execute External Audits and Inspections.
• Manage site Quality Assurance function to ensure compliance.
• Accountable for site QA department headcount and budget.
• Work with QA Department Director(s) and/or Associate Director(s) to assess and develop current and future headcount and training needs.
• Responsible for QA Department personnel management and recruit, hire, develop, train and mentor QA Department Associate Director/Director.
• Develop, maintain and review QMS and QA Department metrics.
• Performs other duties as assigned.

Supplemental Data
Minimal travel required for training or cross-functional project development activities.
Training and Education
Bachelor of Science in technical or scientific discipline required master's degree preferred.

Additional training/experience and expertise is expected in the following: Quality Management System, including MDSAP, 21 CFR parts 7, 11, 806, 820, ISO 13485, 14971, 9001, IVDD and IVDR.

A current or past certification as an ASQ Certified Quality Engineer (CQE), Certified Manager of Quality- Organization Excellence (CMQ/OE), Certified Quality Auditor (CQA) or Six Sigma Black Belt are beneficial and preferred
Minimum 15 years of leadership experience in an IVD, MD or pharmaceutical environment is required in lieu of degree
Experience

• Prefer a minimum of 6 years working with commercialized IVD(R) products for both instruments and

reagents.

• Prefer a minimum 15 years of experience in Quality with increasing levels of responsibility in a medical

device and/or Pharmaceutical environment. 2 years of this experience may be substituted by a Master's

Degree in a life science or engineering discipline.

• Prefer a minimum 10 years management experience including direct management of Quality Assurance

team directly supporting manufacturing in medical device or Pharmaceutical environment.

• Prefer a minimum of 5 directly overseeing a Quality Control laboratory in medical device or

Pharmaceutical environment

• Must have experience leading Quality systems at a high level in a relevant regulated environment,

including experience directly managing regulatory audits by FDA and Notified Body.

• Experience as the Site Quality Leader for IVD(R) manufacturing is preferred
• Must have expertise in hosting/managing broad scope regulatory audits including IVD(R)

Knowledge, Skills, and Abilities
Expert knowledge in the interpretation and application of relevant Domestic and International Regulations and Standards (e.g. MDSAP, FDA QSR (eg. 21 CFR 820), ISO 13485, IVDR).
Demonstrated ability to influence and drive for improvement within a large manufacturing site.
Knowledge and competence in the selection and use of Quality Engineering tools, techniques, and processes.
Ability to quickly differentiate between issues that can be resolved at this level and those that should be

escalated.

Tactical management and people skills are required and applied in the supervision of employees and negotiation with employees in other departments.

Must possess the ability to communicate and collaborate across departments and throughout all levels of the organization.

Demonstrate high expertise in managing large scope regulatory audits Demonstrate high proficiency in following: General computer operation, internet navigation MS Office applications: Word, Excel, PowerPoint, Outlook, Teams, and Sharepoint.

Demonstrate basic proficiency in MS Office applications:
Visio, Lucidchart


Desired:
Statistics and data analysis, basic SAP proficiency.

#J-18808-Ljbffr