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 Manager of Supplier Quality 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: 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 $96,000 - $120,000 based on qualifications and experience.
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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,…