Senior Quality Control Manager - BioScience

Smithfield Foods • Cincinnati, OH

9d

About The Position

Are you ready to play a pivotal role in ensuring the highest standards in pharmaceutical and medical device manufacturing? We're looking for a passionate and driven professional to take on a full-time position reporting to the Head of Quality. In this key leadership role, you’ll be at the forefront of Quality Control operations, championing compliance with current Good Manufacturing Practices (cGMP) and driving the integrity and excellence of our products and quality systems. Your mission: to uphold and elevate quality across all laboratory operations, from testing Active Pharmaceutical Ingredients (APIs) to critical medical device components. You’ll ensure every procedure aligns with global regulatory standards, including 21 CFR Parts 210/211, ICH Q7, ISO 22442, and EU guidelines—safeguarding not just our operations, but ultimately the patients who rely on our products. If you thrive in a fast-paced, quality-first environment where precision and leadership matter, this is the opportunity to make a real impact.

Requirements

• Bachelor's degree from an accredited four-year college or university in a chemistry, microbiology or other relevant technical field and 8+ years of demonstrated experience in FDA cGMP compliance environment in a QC laboratory.
• 2+ years of demonstrated experience in team management/development or project leadership is required
• Candidates with a Master’s Degree chemistry, microbiology or other relevant technical field from an accredited four-year college or university and 6+ years relevant experience will be considered qualified.
• Demonstrated leadership skills and the ability to uphold regulatory, company, and customer standards.
• Proficient with complex mathematical calculations, technical writing, interpersonal and communication skills (written and verbal).
• Ability to structure work plans and organize employees to achieve results with demonstrated ability to manage multiple priorities in a fast-paced environment.
• Capable of working well with cross-functional teams in a dynamic setting to achieve company goals.
• Works well in high pressure situations.
• Strong Communicator: Exceptional written and verbal communication skills, capable of articulating complex technical issues clearly and concisely across all levels of the organization.

Nice To Haves

• Bilingual communication in Mandarin and English is preferred.

Responsibilities

• Quality Control Leadership Take charge of QC operations by ensuring all testing is conducted accurately, reported promptly, and meets regulatory standards.
• Provide hands-on leadership and sound decision-making in lab-related matters, keeping everything on track and in compliance.
• Lead investigations for OOS, CAPA, Complaints, and Deviations, ensuring thorough and timely resolution in line with procedures.
• Cross-Functional Collaboration Serve as the QC voice in cross-functional discussions—working closely with Quality Assurance and Production teams to keep manufacturing workflows efficient and product release timelines on point.
• Keep site management informed about critical lab needs, including software or equipment required for continued compliance.
• Regulatory & Compliance Readiness Maintain a state of constant inspection readiness in the QC lab, supporting FDA and other regulatory authority inspections with confidence.
• Report laboratory deviations and Out-of-Specification (OOS) occurrences to QA and ensure appropriate follow-up.
• Assist in testing of raw materials, in-process samples, and finished goods for compliance with SOPs and regulatory expectations.
• Process Optimization & Continuous Improvement Monitor and report key quality metrics to senior leadership, using data-driven insights to support continuous improvement.
• Regularly review and collaborate on updates to laboratory SOPs to reflect best practices and evolving standards.
• Method Development & Validation Develop and validate new laboratory methods and support computer system validations through the preparation of protocols, execution of studies, and reporting.
• Training & Equipment Oversight Manage lab equipment usage and maintenance to ensure peak performance and cGMP compliance.
• Support the training and onboarding of QC analysts and management on laboratory methods, instrumentation, and procedures.

Benefits

• Smithfield is proud to offer robust, flexible and affordable benefit plans and programs to support our team members and their loved ones, and with out-of-pocket costs, on average, 20 percent less than plans offered by other employers.
• Beyond our medical plans, our Be Well programs offer tools and resources to enhance your quality of life, at no additional cost.
• These programs are uniquely tailored to our Smithfield team and provide support for elective surgeries, weight loss, mental health, cancer, kidney disease, diabetes, smoking cessation, asthma, maternity management and more.
• Our company invests in your future. We offer comprehensive training and professional development programs designed to help you reach your full potential.
• Our partnership with GUILD supports your continuing education with tuition assistance covering English language learning and various certificate programs, while our leadership development initiatives nurture high-potential talent.
• For those looking to build specialized skills, we offer apprenticeship programs that combine hands-on experience with focused learning.
• We also offer unique benefits like our Smithfield Scholarship Program for employees’ children.
• Smithfield’s Education Reimbursement Program provides financial reimbursement to team members who want to further their formal education by obtaining a GED/High School Equivalency (HSE) Diploma or by pursuing an academic degree at an accredited college or university that is not a Guild learning partner.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior