ProBio

Biologics and CGT CDMO platform

Manager – Supplier Quality

Regulatory & Quality (Life Sciences)Updated on Nov 12

Full-timePennington, NJ, USA$96k - $120k

About the Job

Requirements

A bachelor's degree in Science, Engineering, Business, Management, or a related field is required; an advanced degree is a plus.
At least 4 years of experience in Quality, Manufacturing, Engineering, or a related field is required.
Strong interpersonal, communication, and negotiation skills are required.
Strong organizational and problem-solving abilities are required.
High attention to detail and accuracy is required.
The ability to work collaboratively in a team environment is required.

Responsibilities

Interpret, build upon, and comply with company quality assurance standards.
Manage daily supplier quality activities and controls.
Support the Strategic Supplier Qualification and Management process to meet quality, delivery, and cost objectives.
Develop and execute strategic plans to improve supplier quality, delivery, and costs.
Oversee the inbound material release process.
Champion quality assurance procedures, tools, and techniques.
Oversee the external audit program.
Hire, train, mentor, and manage a small team to execute supplier qualification and supporting program tasks.
Author and review standard operating procedures (SOPs).
Oversee the Good Manufacturing Practice (GMP) supplier qualification program and supplier risk management.
Complete approval requirements to qualify new suppliers, including negotiating quality agreements.
Periodically review suppliers and identify supplier compliance issues.
Manage vendor complaints.
Participate in or manage quality assessments of internal operations and suppliers to analyze compliance and assess risk.
Liaise between suppliers and Quality Assurance representatives to address supply-chain quality concerns.
Monitor supplier non-conformance performance and drive root-cause analyses, corrective actions, and process improvements to reduce defects and cost of quality.
Ensure timely investigation and closure of corrective and preventive actions (CAPAs), supplier non-conformances, complaints, and product issues.
Develop and maintain measurement systems for quality costs, indicators, trends, and supplier ratings.
Collect data and compile supplier scorecards.
Manage the audit schedule and execute supplier audits.
Generate specifications for materials and consumables.
Make disposition decisions for materials and consumables.
Approve calibration reports for GMP equipment.
Support Quality Assurance Validation in reviewing SOPs.
May interface with auditors during regulatory inspections.
Supervise and delegate responsibilities to a small team.
Train and mentor subordinates.
Work closely with Facilities, Quality Assurance Validation, Manufacturing, and Quality Control teams.
Travel less than 10%.

Desired Qualifications

An advanced degree is a plus.

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: < 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 $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, 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.

Salary: 0.0 - 0.0

About the Company

ProBio

Biologics and CGT CDMO platform

ProBio (GenScript ProBio) is a biologics and cell/gene therapy CDMO platform that offers end-to-end services from antibody and protein discovery through commercial manufacturing, plus plasmid, viral vector, and mRNA CMC services. It operates GMP-capable facilities in China and the United States and has supported 100+ IND filings for global clients since 2017. The company, spun from GenScript, provides a full suite of development and manufacturing options, enabling clients to move products from discovery to market readiness. Unlike many single-solution providers, ProBio covers the entire spectrum of biologics and CGT workflows in-house, with multi-region GMP capacity and a track record of regulatory support. Its goal is to help customers bring biologics and gene-therapy products to clinical trials and commercial production by offering integrated, globally accessible CDMO services.

Company size: Not listed
Company stage: Not listed
Total funding: Not listed
Headquarters: Nanjing City, China
Founded: 2017

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