Supervisor, Quality Assurance
Minaris Regenerative Medicine GmbH, Allendale, NJ, United States
Allendale, 75 Commerce Drive, Allendale, New Jersey, United States of America
Job Description
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 overview to Quality Assurance team according to Minaris Quality policies, procedures, and standards. Provide overview 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.
Essential Functions and 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
Leadership Responsibility
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
Knowledge, Skills & Ability
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
Education & Experience
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 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.
Experience participating in or hosting health authority inspections and/or client audits.
Quality Requirements
Ensure compliance with all FDA and Worldwide Quality & Compliance regulations in all aspects of your work.
Adhere to established procedures and protocols, prioritize continuous training and skill development, and uphold the highest standards of data integrity to ensure accuracy, compliance, and operational excellence.
Onsite Employees:
Employee will work with moderate noise level. Employee will perform tasks while experiencing numerous interruptions. Employee may travel by car and airplane to work at different locations and may occasionally be required to travel overnight. The work environment is fast paced. This position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment relative to their actions and conduct. Off‑shift, weekend and overtime duties may be required. While performing the job duties of this job, the employee is regularly required to use English written and oral communication skills.
Physical Requirements
The physical and mental demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
While performing the duties the employee is:
Constantly required to sit, and to reach to use computers and other office equipment
Constantly stand for extended periods of time, up to four hours/time
Frequently required to lift up to 40 pounds
Constantly required to view objects at close and distant ranges with hand and eye coordination
Frequently required to communicate with others
Note: For the purpose of this summary, occasionally is used to represent up to 1/3 of the time given to the work day; frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time.
Special Working Conditions
Must have the ability to work in a team‑oriented environment and with clients
Must be able to work during the weekend, holidays and as required by the company
May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens
Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen
Must be able to handle the standard/moderate noise of the manufacturing facility
May work with hazardous materials and chemicals
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.
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Job Description
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 overview to Quality Assurance team according to Minaris Quality policies, procedures, and standards. Provide overview 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.
Essential Functions and 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
Leadership Responsibility
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
Knowledge, Skills & Ability
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
Education & Experience
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 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.
Experience participating in or hosting health authority inspections and/or client audits.
Quality Requirements
Ensure compliance with all FDA and Worldwide Quality & Compliance regulations in all aspects of your work.
Adhere to established procedures and protocols, prioritize continuous training and skill development, and uphold the highest standards of data integrity to ensure accuracy, compliance, and operational excellence.
Onsite Employees:
Employee will work with moderate noise level. Employee will perform tasks while experiencing numerous interruptions. Employee may travel by car and airplane to work at different locations and may occasionally be required to travel overnight. The work environment is fast paced. This position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment relative to their actions and conduct. Off‑shift, weekend and overtime duties may be required. While performing the job duties of this job, the employee is regularly required to use English written and oral communication skills.
Physical Requirements
The physical and mental demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
While performing the duties the employee is:
Constantly required to sit, and to reach to use computers and other office equipment
Constantly stand for extended periods of time, up to four hours/time
Frequently required to lift up to 40 pounds
Constantly required to view objects at close and distant ranges with hand and eye coordination
Frequently required to communicate with others
Note: For the purpose of this summary, occasionally is used to represent up to 1/3 of the time given to the work day; frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time.
Special Working Conditions
Must have the ability to work in a team‑oriented environment and with clients
Must be able to work during the weekend, holidays and as required by the company
May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens
Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen
Must be able to handle the standard/moderate noise of the manufacturing facility
May work with hazardous materials and chemicals
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.
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