Minaris Advanced Therapies · 15 hours ago
Supervisor, Quality Assurance
Allendale, NJ
Full-time
Onsite
Senior Level
5+ years expMinaris Advanced Therapies is a global leader in cell and gene therapy development, manufacturing, and testing. The Supervisor, Quality Assurance is responsible for providing oversight to the Quality Assurance team, ensuring compliance with quality policies, and coordinating training and performance management within the department.
BiotechnologyHealth CareManufacturing
Responsibilities
Provide oversight of QA floor support team
Supervise, prioritizes, and coordinates the daily activities of the QA staff within the department
Facilitates internal training on quality assurance requirements, processes, and procedures
Provides technical expertise to the client services team on tech transfer activities
Must have knowledge in investigations, CAPA, change control and complaint process
Manage Batch issuance and Batch Record Tracking System
Review and approve Minaris SOPs, WIs, and Forms
Supports QA teams with continuous improvements initiatives to enforce quality culture
Initiate critical change control as required
Assist gathering information for internal and external (e.g. cGMP, client, regulatory agencies) audits
Support walk-thru in preparation for internal and external (e.g. cGMP, client, regulatory agencies) audits
Regular and reliable attendance on a full-time basis
Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices
Embodies Minaris Advanced Therapies values and aligns daily actions with department and company culture
GXP training
SOP & WI training
Safety Training
Supports a diverse and inclusive culture and workforce, ensures compliance with laws, regulations, and company policies
Identifies, recruits, and retains top-notch talent
Sets performance standards and encourages employee engagement through delegation, continuous feedback, goal setting and performance management
Develop employees to meet both their career and organizational goals
Builds strong customer relationships and delivers customer-centric solutions
Maintains transparent communication, appropriately communicates organizational information through department meetings, one-on-one meetings, email, and regular interpersonal communication
Comfortable working in ambiguous situations and adaptable to change
Must model the highest degree of moral and ethical behavior and maintain confidential information
High degree of autonomy and strong decision-making skills
Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws
Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems for the following positions. Directly supervise the following roles: QA Associate I, QA Associate II, QA Associate III
Qualification
Required
Bachelor of Science in biological sciences or other relevant field of study
Minimum 5 years' experience in QA in a life sciences company with a strong focus in the manufacturing and/or testing of biologics. Working knowledge and technical understanding of aseptic manufacture of biologics
Minimum 1-year supervisory experience. Equivalent combination of education and experience acceptable
Provide oversight of QA floor support team
Supervise, prioritizes, and coordinates the daily activities of the QA staff within the department
Facilitates internal training on quality assurance requirements, processes, and procedures
Provides technical expertise to the client services team on tech transfer activities
Must have knowledge in investigations, CAPA, change control and complaint process
Manage Batch issuance and Batch Record Tracking System
Review and approve Minaris SOPs, WIs, and Forms
Supports QA teams with continuous improvements initiatives to enforce quality culture
Initiate critical change control as required
Assist gathering information for internal and external (e.g. cGMP, client, regulatory agencies) audits
Support walk-thru in preparation for internal and external (e.g. cGMP, client, regulatory agencies) audits
Regular and reliable attendance on a full-time basis
Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company's policies and practices
Embodies Minaris Advanced Therapies values and aligns daily actions with department and company culture
GXP training
SOP & WI training
Safety Training
Supports a diverse and inclusive culture and workforce, ensures compliance with laws, regulations, and company policies
Identifies, recruits, and retains top-notch talent
Sets performance standards and encourages employee engagement through delegation, continuous feedback, goal setting and performance management
Develop employees to meet both their career and organizational goals
Builds strong customer relationships and delivers customer-centric solutions
Maintains transparent communication, appropriately communicates organizational information through department meetings, one-on-one meetings, email, and regular interpersonal communication
Comfortable working in ambiguous situations and adaptable to change
Must model the highest degree of moral and ethical behavior and maintain confidential information
High degree of autonomy and strong decision-making skills
Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws
Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems for the following positions. Directly supervise the following roles: QA Associate I, QA Associate II, QA Associate III
Detail-oriented and organized
Analytical and problem-solving skills
Good written and oral communication skills
Ability to multi-task and be adaptable
Flexible and able to adapt to company growth and evolving responsibilities
Ability to work independently and with a team
Strong Project Management and organization skills
Confident in making decisions on non-routine issues
Preferred
Experience in both clinical and commercial manufacturing is preferred
Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents MBR, reports, SOPS. Etc
Experience in organizing teams for effective and timely completion of projects
Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc
Relevant computer skills (Microsoft Office, Outlook)
Experience participating in or hosting health authority inspections and/or client audits
Benefits
Medical insurance
Vision insurance
Dental insurance
401(k)
Paid time off
Tuition assistance
And more
Company
Minaris Advanced Therapies
Minaris Advanced Therapies is a global cell and gene therapy (CGT) CDMO and a multimodality biosafety testing provider.
1001-5000 employees
H1B Sponsorship
Minaris Advanced Therapies has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2022 (1)
2021 (1)
Funding
Current Stage
Late StageTotal Funding
unknown2025-01-07Acquired
Leadership Team
William Burckardt
Chief Financial Officer, North America
Enid Agosto
Senior Administrative Assistant to CFO and Head of People & Organizational Development
Recent News
Seattle TechFlash
2025-08-18
2025-07-22
Company data provided by crunchbase