Site Quality Manager - Florida, United States - Kerry Search Partners

Kerry Search Partners Florida, United States

2 weeks ago

Description

Global Life-Sciences Company ($50bn)

High-performing & fastest-growing business unit
Forefront of technology
Strategic role
Biologics

Are you a seasoned quality leader with a passion for driving strategic initiatives and delivering impactful results? Look no further We invite you to be part of our renowned $50 billion global leader in healthcare and scientific solutions, where innovation meets purpose.

Why Us?

At our organization, we are not just shaping the future of healthcare and scientific advancements; we are defining it. Join a team of trailblazers committed to revolutionizing the industry with groundbreaking solutions and transformative breakthroughs.

Your Role: Senior Quality Manager - Site Quality Head

In this strategic role, you will lead the Quality organization for the entire site. This role will be responsible for building a customer-focused quality culture and associated quality processes. This includes a dedication to optimizing the customer experience through customer feedback and delivering products that represent industry-leading standards of product quality.

Key Responsibilities:

Defines the Quality strategy for the Biologics products in alignment with Division, Group and Company goals. Ensures adequate deployment and execution of such strategy.
Provides Quality leadership for a multi-site network.
The position is expected to be customer facing, building professional relationships with their Quality counterparts within the customer organizations
Ensure all product value stream touch points are aligned to deliver Quality products and processes
Drives resolution to quality issues as needed and communicates internally to senior leaders and to diverse audiences in an effective manner.
Applies Quality Risk Management to prevent risk of failure modes that impact supply of consistent supply of Quality products

Qualifications:

Bachelor's degree or higher in Science, engineering or similar fields
10+ years or more experience within the Pharmaceutical, Biotechnology or Medical Device Industry - supporting Regulated Products
At least 2 years of experience leading a multi-site organization
Audit (ISO9001 or similar) or inspection (FDA or similar) management experience
Experience in Quality Management System design and oversight from a pharmaceutical perspective and/or medical device field
Knowledge of Compliance with quality standards (e.g., 21 CFR Part 820, 21 CFR Part 11, ISO 13485, 9001)
Experience with the use of key quality tools e.g. FMEA, Risk Analysis, RCA and global systems e.g. TrackWise, AGILE, E1/SAP, LIMS or similar
Competency of bioprocessing technology and capabilities, pharmaceutical production, pharmaceutical new product or medical device introductions
Knowledge of project-based manufacturing processes including capital electromechanical equipment
Regulatory Affairs Experience and/or RAPS Certification or ASQ Quality Certifications would be a plus

If you're ready to elevate your career and make a meaningful impact in a dynamic and forward-thinking organization, we want to hear from you.

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