Senior Quality Control Manager (Fort Worth, TX)

Smith+NephewFort Worth, TX
7dHybrid

About The Position

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?

Requirements

  • A Bachelor’s degree in Chemistry, Microbiology, Pharmaceutical Sciences or a related scientific discipline
  • Extensive Quality Control experience within pharmaceutical drug product manufacturing, with strong exposure to 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

Responsibilities

  • 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

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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