Quality Systems and Standards Manager- BioScience

Overview Step Into a High-Impact Role in Quality Assurance! Ready to make a real difference in the world of pharmaceutical and medical device manufacturing? Smithfield BioScience, Inc. (SBC) is seeking a quality-driven professional for a full-time role reporting to the Senior Quality Assurance Manager. Responsibilities Lead enforcement of current Good Manufacturing Practices (cGMP) and safeguard the integrity of our quality management systems. Own the Quality Management System, maintain compliance with all applicable regulations (21CFR Parts210/211, ICHQ7, ISO22442, EU guidelines). Lead continuous‑improvement activities through the Site Quality Council and implement the Site Quality Road Map. Develop and maintain standard operating procedures, tools and monitoring controls for key QMS processes (e.g., deviations, change control, CAPAs). Monitor Key Quality Performance Indicator (KPI) dashboards to track site quality system performance. Provide annual data‑integrity awareness and training, ensuring adherence to ALCOA+ principles. Manage customer complaint handling process and maintain a site risk register. Execute Quality Council reviews, identify compliance gaps and communicate risks to management. Develop, oversee, and maintain the Site Quality Plan/Roadmap and Validation Master Plan. Govern SOPs and Technical Quality Agreements, ensuring relevance and completeness. Coach, mentor, and develop the QA team, fostering a culture of quality‑first thinking. Skills & Competencies Proficiency with digital quality systems such as TrackWise. Strong knowledge of pharmaceutical manufacturing processes and GMP application. Experience writing and editing technical documents. Familiarity with risk‑management principles and tools (e.g., FMEA, risk assessment). Excellent written and verbal communication skills. Bilingual communication in Mandarin and English is preferred. Analytical thinking and data‑driven decision making. Qualifications Bachelor’s degree in an engineering, chemistry, microbiology, or related technical field and 5+ years of relevant manufacturing experience (or equivalent). Advanced experience in API manufacturing highly preferred. Minimum 2 years of demonstrated team‑management or project‑leadership experience in API pharmaceutical cGMP manufacturing. Master’s degree and 3+ years of API cGMP manufacturing experience considered qualified. In‑depth knowledge of 21CFR Part210/211, ICHQ7, and related regulations. Strong understanding of Good Manufacturing Practices and data‑integrity principles (ALCOA+). Experience with digital QMS tools (TrackWise). Preferred certifications: Certified Quality Manager (CQM), Certified Quality Auditor (CQA), Six Sigma Black Belt. Bilingual communication in Mandarin and English (preferred). Benefits We provide robust, flexible, and affordable benefit plans and programs that support our team members and their families. Health, dental, vision, and life insurance options are available along with a generous paid‑time‑off policy and wellness programs such as weight‑loss support, mental health resources, and more. Tuition assistance, professional development funding, and a scholarship program are also offered. Salary Salary Range: $96,000 - $144,000. Relocation Package Available. EEO Statement Smithfield is an equal opportunity employer committed to workplace diversity. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, age, gender identity, protected veterans status, status as a disabled individual or any other protected group status or non‑job characteristic as directed by law. If you are an individual with a disability and would like to request a reasonable accommodation for any part of the employment selection process, please call us at View phone number on click.appcast.io. #J-18808-Ljbffr Smithfield Bioscience, Inc