Supervisor Quality Assurance Manufacturing

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
Supervise compliance department employees, resources and programs to ensure compliance with all regulatory requirements; specifically Good Manufacturing Practice (cGMP), Code of Federal Regulations (CFR), Points to Consider (PTC), International Conference on Harmonization (ICH), Good Laboratory Practices (GLP), Good Tissue Practices (GTP) and relevant foreign regulatory guidelines for biopharmaceuticals. Supervise compliance-critical functions for the site and review related documentation. Monitor, trend and report on aspects of the Quality Systems by working within the department and with other departments to supervise the Quality Systems using MasterControl, when necessary. Identify, implement and drive quality improvement projects and policies to reflect industry’s best practices.

Essential Functions and Responsibilities

• Lead and supervise employees to ensure that employees are fully-trained, providing adequate leadership, mentoring, and support. Including active maintenance in keeping the site current with changes to GXP, including FDA and EU and other relevant foreign regulatory bodies as well as guidance documents (ie: ICH, PTC, ISPE, etc.).
• Administer the MasterControl system and any associated modules. Assist STP and ATL MasterControl administrators as needed.
• Ensure that the appropriate systems are implemented to ensure a consistent level of quality and compliance in all processes. Monitor and maintain quality systems and procedures (SOPs) for adherence to regulatory compliance requirements. Focus on driving continuous compliance and quality improvements. Develop, implement and approve QA policies and procedures.
• Drive and support in compliance-critical functions specifically the MasterControl system and associated processes.
• Perform trend analysis, report results on compliance critical functions and coordinate corrective and preventative actions (CAPA) to drive compliance, future quality initiatives and resource allocation.
• Review, approve and perform investigations and provide guidance for CAPA related to non-compliance situations using creative problem-solving skills.
• Conduct internal, external and vendor/supplier audits and program(s).
• Lead and/or participate on cross-functional teams and projects representing quality in positive and compliant manner. Work and interact in a collaborative manner at all levels of the organization.
• Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
• Normally receives minimal instructions on routine work and detailed instructions on new assignments.
• Works under close supervision from managers or senior personnel.
• Ability to work in a team environment and independently as required
• Maybe required to work Holidays and weekends
• Contributes to the overall operations and to the achievement of departmental goals
• Perform job specific tasks in compliance with applicable Regulations, International Standards, and Minaris Advanced Therapies Policies and Standard Operating Procedures.
• Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices
• Performs other duties as assigned

Knowledge, Skills & Ability

• Thorough understanding of regulatory requirements for cGMP manufacturing facility, especially as they apply to cleaning practices/sterility assurance.
• Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations
• Must be able to wear appropriate clean room attire (i.e. surgical masks) and all Personal Protective Equipment (PPE).
• Works in production environment with exposure to latex and bleach. Potential exposure to noise and equipment hazards (i.e. vacuum pumps, pressurized vessels), dangerous materials (i.e. chemicals, solvents, pathogens), freezer burns, allergens and strong odors.
• Based on work assignments, it may be recommended to have medical testing in accordance with the company’s Occupational Health Program.
• Holiday and shift work are often required based on manufacturing schedule as determined by Management.
• Proficient in Oral & Written communication skills
• Need to be able to read, write and understand English
• Proficient in Microsoft (Excel, Word, Outlook)

Education & Experience

• 5 or more years of relevant experience or equivalent
• Bachelor’s degree in a Science related field or equivalent experience

Disclaimer
The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. Duties, responsibilities, and activities may change at any time with or without notice.

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.