Supervisor, Quality Assurance

Minaris Advanced Therapies • Allendale, NJ

18h

About The Position

Be part of something bigger at Minaris Advanced Therapies—where every role contributes to creating hope for patients around the world. As a global leader in cell and gene therapy development, manufacturing, and testing, we turn breakthrough science into real-world treatments that change lives. Our team of over 1,000 experts across North America, Europe, and Asia has helped bring transformative therapies to market. At Minaris, you’ll join a purpose-driven community focused on innovation, collaboration, and patient impact. Whether you’re in the lab, in the cleanroom, or behind the scenes, your work will directly support life-saving therapies and make a lasting difference. If you're passionate about advancing cutting-edge science and believe in the potential of cell and gene therapies, we invite you to help shape the future of medicine—one patient at a time. Position Summary The Supervisor, Quality Assurance is responsible for providing quality oversite to Quality Assurance team according to Minaris Quality policies, procedures, and standards. Provide oversite for material releases, final product releases; as well as assists Quality management with department needs. He/she exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. He/she helps the team understand performance targets and goals. Ensuring that workers are properly trained for their specific roles. Coordinating job rotation and cross-training.

Requirements

• 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
• 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
• 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)

Nice To Haves

• Experience in both clinical and commercial manufacturing is preferred.
• Experience participating in or hosting health authority inspections and/or client audits.

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

Benefits

• Minaris Advanced Therapies employees are eligible for a comprehensive benefits package, including medical insurance, vision insurance, dental insurance, 401(k), paid time off, tuition assistance, and more.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 251-500 employees