Senior Quality Control Manager (Fort Worth, TX)

Smith & Nephew Plc

Fort Worth, TX

JOB DETAILS
SKILLS
Analysis Skills, Asepsis, Biotech and Pharmaceutical, Chemistry, Coaching, Code of Federal Regulations, Communication Skills, Continuous Improvement, Corrective Action, Documentation, Drug Manufacturing, Drug Products, Environmental Monitoring, Environmental Work, FDA (Food and Drug Administration), Fitness, GMP (Good Manufacturing Practices), Laboratory, Laboratory Management, Laboratory Operations, Laboratory Systems, Leadership, LinkedIn, Manufacturing, Manufacturing Operations, Materials Testing, Mentoring, Microbiology, Ointments, Operational Support, Patient Care, Quality Assurance, Quality Assurance Methodology, Quality Control, Quality Management, Regulations, Root Cause Analysis, Stock Purchase Plans, Technical Leadership, Time Management
LOCATION
Fort Worth, TX
POSTED
30+ days ago

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

  • 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

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.

About the Company

S

Smith & Nephew Plc

The Group has a history dating back 160 years to the family enterprise of Thomas James Smith who opened a small pharmacy in Hull, England in 1856. On his death in 1896, his nephew Horatio Nelson Smith took over the management of the business. Thomas James Smith black and white photograph Image: Thomas James Smith A few days after the declaration of World War 1 in 1914, Horatio Nelson Smith (the nephew of the company founder T. J Smith) met with an envoy of the French President in London. The company was awarded a contract to supply £350,000 of surgical and field dressings, to be delivered in five months. By the late 1990s, Smith & Nephew had expanded into being a diverse healthcare conglomerate with operations across the globe, including various medical devices, personal care products and traditional and pioneering woundcare treatments. In 1998, Smith & Nephew announced a major restructuring to focus management attention and investment on three business units — wound management, endoscopy and orthopaedics — which offered high growth and margin opportunities. Smith & Nephew was incorporated and listed on the London Stock Exchange in 1937 and in 1999 the Group was also listed on the New York Stock Exchange. In 2001, Smith & Nephew became a constituent member of the FTSE-100 index in the UK. This means that Smith & Nephew is included in the top 100 companies traded on the London Stock Exchange measured in terms of market capitalisation. Today, Smith & Nephew is a public limited company incorporated and headquartered in the UK and doing business in many countries around the world.
COMPANY SIZE
2,000 to 2,499 employees
INDUSTRY
Medical Devices and Supplies