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Smith & Nephew

Senior Quality Control Manager (Fort Worth, TX)

Reposted 2 Days Ago
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In-Office
Fort Worth, TX
Senior level
In-Office
Fort Worth, TX
Senior level
The Senior Quality Control Manager will lead QC operations, oversee testing, manage teams, drive investigations, ensure GMP compliance, and support aseptic manufacturing.
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Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.

As a Senior Quality Control Manager, you will play a critical leadership role within our Drug Product Operations, ensuring the highest standards of quality, compliance and scientific excellence. This is an opportunity to lead a high performing QC team, influence key quality decisions and make a meaningful impact on products that improve patients’ lives every day.

What will you be doing?

  • Leading and overseeing day to day Quality Control laboratory operations to ensure timely and accurate testing of raw materials, in process samples, finished products and stability samples

  • Acting as the primary decision maker for QC investigations including OOS, OOT and atypical results, applying robust root cause analysis to drive sustainable corrective actions

  • Providing technical leadership and subject matter expertise across semi solid, liquid, ointment and cream formulations and analytical testing methods

  • Supporting aseptic manufacturing operations, environmental monitoring programs and sterility assurance activities in close partnership with Manufacturing and Quality Assurance

  • Developing, mentoring and coaching QC analysts and supervisors, building strong technical capability and fostering a culture of accountability and continuous improvement

  • Ensuring all QC documentation, policies and laboratory systems meet GMP and GDP requirements, while leading audits and supporting regulatory inspections

What will you need to be successful?

  • A Bachelor’s degree in Chemistry, Microbiology, Pharmaceutical Sciences or a related scientific discipline

  • Minimum 10 years of progressive Quality Control experience in the pharmaceutical drug product industry

  • 5 years experience specifically with semi solids, liquids, ointments, and creams.

  • Proven leadership experience managing and developing QC teams in a GMP regulated environment

  • Deep working knowledge of FDA 21 CFR Parts 210 and 211, with hands on experience leading laboratory investigations and root cause analysis

  • Experience supporting aseptic manufacturing operations and associated quality requirements

  • Strong communication skills with the ability to partner effectively across Manufacturing, Quality Assurance and other stakeholders

You. Unlimited.
We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.

Inclusion and Belonging- Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/).
Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Purchase Plan, Tuition Reimbursement
Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day
Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program
Flexibility: Hybrid Work Model (For most professional roles)
Training: Hands-On, Team-Customized, Mentorship
Extra Perks: Discounts on fitness clubs, travel and more!

Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.

Stay connected by joining our Talent Community.

We're more than just a company - we're a community! Follow us on LinkedIn to see how we support and empower our employees and patients every day.  

Check us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at S+N.

Explore our website and learn more about our mission, our team, and the opportunities we offer. 

 

Top Skills

Analytical Testing Methods
Aseptic Manufacturing Operations
Fda 21 Cfr Parts 210
Fda 21 Cfr Parts 211
Quality Control Laboratory Operations

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