Quality Transformation Manager (Fort Worth, TX)
About The Position
Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. Are you passionate about driving meaningful change in a regulated environment? This is a highly visible opportunity to lead quality transformation initiatives that directly support capacity expansion, operational excellence and quality system maturity at our Fort Worth site. As a Quality Transformation Manager, you will act as a catalyst for change, partnering across functions to deliver sustainable improvements that make a real impact for patients and the business.
Requirements
- 8–12 years of experience in Quality Control (QC), Quality Assurance (QA), and/or Quality Systems within pharmaceutical, biologics, or sterile drug product environments.
- Bachelor’s degree in a scientific or engineering discipline required; Master’s degree preferred (demonstrates advanced analytical, organizational, and leadership competencies).
- Strong hands on expertise with eQMS platforms and quality processes such as deviations, investigations, CAPAs and change control
- Proven experience leading transformation initiatives, process improvements or system implementations
- Deep understanding of regulatory requirements for drug product, sterile manufacturing and biologics
- Excellent written and verbal communication skills with the ability to influence without direct authority
- A proactive, self starting approach with the ability to drive complex initiatives from concept through to completion
Responsibilities
- Leading and executing quality transformation initiatives that increase capacity, optimize operations and strengthen quality system maturity
- Acting as a hands on project manager and subject matter contributor for process redesign, system upgrades and optimization activities
- Driving improvements across core quality systems including deviations, change control, CAPAs, investigations, document control and training
- Serving as a functional expert for electronic Quality Management Systems such as Veeva, TrackWise, MasterControl or similar platforms
- Authoring high quality technical documentation including procedures, protocols, reports and strategy documents
- Collaborating and influencing across Manufacturing, Engineering, Supply Chain, QC and Global Quality to align stakeholders and deliver results
- Facilitating workshops, problem solving sessions, readiness assessments and cross functional meetings
- Applying strong analytical and root cause thinking to identify issues early and implement effective corrective strategies
Benefits
- 401k Matching Program
- 401k Plus Program
- Discounted Stock Purchase Plan
- Tuition Reimbursement
- Flexible Personal/Vacation Time Off
- Paid Holidays
- Flex Holidays
- Paid Community Service Day
- Medical, Dental, Vision
- Health Savings Account (Employer Contribution of $500+ annually)
- Employee Assistance Program
- Parental Leave
- Fertility and Adoption Assistance Program
- Hybrid Work Model (For most professional roles)
- Discounts on fitness clubs, travel and more!
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
5,001-10,000 employees
