Sr. Supervisor, QA Technical operations

ProBio, a subsidiary of GenScript, is a global CDMO offering end-to-end services from discovery to GMP for plasmids, antibodies, and cell & gene therapies. We bring together multidisciplinary expertise to accelerate development and manufacturing through customized, and comprehensive services. ProBio has established companies in the United States, the Netherlands, South Korea, and China (Hong Kong, Shanghai, and Nanjing) and other regions to serve global customers, and has helped customers in the United States, Europe, Asia Pacific and other regions obtain more than 150 IND approvals since October 2017. The Sr. Supervisor of QA Technical Operations will be responsible for: Interpreting, building upon, and complying with company quality assurance standardsManaging daily supplier quality activities and controlsSupporting the Strategic Supplier Qualification and Management process to meet quality, delivery, and cost objectivesDeveloping and executing strategic plans to improve supplier quality, delivery, and costsOverseeing inbound material release processChampion quality assurance procedures, tools, and techniquesOversee external audit programHiring, training, mentoring, and managing a small team to execute tasks related to the supplier qualification and supporting programsRoles and Responsibilities Author/Review SOPsOversee the GMP supplier qualification program and supplier risk managementCompletes the approval requirements to qualify new suppliers including negotiating quality agreementsPeriodic review of suppliers, Identifies supplier compliance issuesManages vendor complaintsParticipates in or manages quality assessments of internal operations and suppliers to analyze compliance and assess riskLiaison between Supplier and QA representatives in addressing the quality concerns from the supply chainMonitor supplier non-conformance performance, and drive root-cause analyses, corrective actions & process improvements to reduce the Number of Defects & Cost of QualityEnsures effective and timely investigation and closure of all CAPA’s, supplier non conformances, complaints and product issuesDevelopment and maintenance of measurement systems for quality costs, indicators, trends and supplier ratingCollects data and compiling supplier scorecardsManages audit schedule and executes supplier auditsGenerates specifications for materials and consumablesResponsible for disposition of materials and consumablesApprove calibration reports for GMP equipmentSupport QA Validation in review of SOPsMay interface with auditors during regulatory inspectionsWill supervise and delegate responsibilities to a small teamTrain and mentor subordinatesWorks closely with Facilities, QA Validation, Manufacturing, and QC teamsTravel 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 fieldResults oriented, driven individualExcellent interpersonal, communication and negotiation skillsStrong organizational and problem-solving abilitiesHigh attention to detail and accuracyAbility 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.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.ProBio Inc. maintains a drug-free workplace. Please note: ProBio Inc. will only contact candidates through verified application sources. Probio does not request personal information from candidates through individual email or any other platform.