- High-performing & fastest-growing business unit
- Forefront of technology
- Strategic role
- Biologics
- 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
- 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
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Description
Global Life-Sciences Company ($50bn)
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 - Leading Site Quality
In this strategic role, you will partner with the VP of Quality and General Manager. 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:
Qualifications:
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.
