Sr. Supervisor, QA Technical operations

About GenScript Founded in 2002 in New Jersey, GenScript Biotech Corporation accelerates innovation in biotech and healthcare by providing researchers and companies with the building blocks needed to develop groundbreaking treatments and products. Guided by its mission to Make People and Nature Healthier Through Biotechnology, and its role as a well-recognized biotechnology company, GenScript has a team of approximately 6,165 employees and has served more than 200,000 customers across over 100 countries and regions. The Sr. Supervisor of QA Technical Operations will be responsible for: - Interpreting, building upon, and complying with company quality assurance standards - Managing daily supplier quality activities and controls - Supporting the Strategic Supplier Qualification and Management process to meet quality, delivery, and cost objectives - Developing and executing strategic plans to improve supplier quality, delivery, and costs - Overseeing inbound material release process - Champion quality assurance procedures, tools, and techniques - Oversee external audit program - Hiring, training, mentoring, and managing a small team to execute tasks related to the supplier qualification and supporting programs Roles and Responsibilities - Author/Review SOPs - Oversee the GMP supplier qualification program and supplier risk management - Completes the approval requirements to qualify new suppliers including negotiating quality agreements - Periodic review of suppliers, Identifies supplier compliance issues - Manages vendor complaints - Participates in or manages quality assessments of internal operations and suppliers to analyze compliance and assess risk - Liaison between Supplier and QA representatives in addressing the quality concerns from the supply chain - Monitor supplier non-conformance performance, and drive root-cause analyses, corrective actions & process improvements to reduce the Number of Defects & Cost of Quality - Ensures effective and timely investigation and closure of all CAPA’s, supplier non conformances, complaints and product issues - Development and maintenance of measurement systems for quality costs, indicators, trends and supplier rating - Collects data and compiling supplier scorecards - Manages audit schedule and executes supplier audits - Generates specifications for materials and consumables - Responsible for disposition of materials and consumables - Approve calibration reports for GMP equipment - Support QA Validation in review of SOPs - May interface with auditors during regulatory inspections - Will supervise and delegate responsibilities to a small team - Train and mentor subordinates - Works closely with Facilities, QA Validation, Manufacturing, and QC teams - Travel expectations: < 10% Qualifications - Bachelor's degree in Science, Engineering, Business, Management or related field (Advance degree a plus) - 4-6+ years of experience in Quality, Manufacturing, Engineering, or related field - Results oriented, driven individual - Excellent interpersonal, communication and negotiation skills - Strong organizational and problem-solving abilities - High attention to detail and accuracy - Ability to work collaboratively in a team environment The estimated pay range for the role is between $90,000 - $110,000 based on qualifications and experience. #AH #PB Benefits: Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and company holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work. GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law. GenScript USA Inc./ProBio Inc. maintains a drug-free workplace. Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.