Director, Quality Control

Minaris Advanced Therapies•Allendale, NJ

20h•Onsite

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. This position will report into the Senior Director of Quality responsible for the oversight and management of Quality Control (analytical and microbiological) at the Clinical and Commercial sites in Allendale, NJ. Responsible for managing the laboratories daily activities and continuous improvement initiatives to ensure compliance and client requirements are met. Core responsibilities include, but not limited to, management of resources (human resources and financial resources), data integrity program and external laboratory management. Collaborates with other departments to support organizational and functional strategy. Represents Quality Control in internal and external audits which may include interaction with regulatory health authorities and clients. Essential Functions and Responsibilities Below is the summary of the role responsibilities. This is not an exhaustive list of all responsibilities, duties, skills, efforts, requirements or working conditions associated with the role. While this is intended to be an accurate reflection of the current job, management reserves the right to revise the job or to require that other or different tasks be performed as assigned with or without notice.

Requirements

Ability to think strategically and tactically (detail-oriented)
Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment.
Analytical and problem-solving skills
Strong written and oral communication skills
Meeting management/facilitation skills/teamwork
Ability to multi-task team is essential
Flexible and able to adapt to company growth and evolving responsibilities.
Ability to effectively interface with peer group in the company and work collaboratively to achieve company goals.
Collaborates with other team members and demonstrates outstanding interpersonal skills.
Ability to work autonomously in an entrepreneurial, fast paced environment.
Strong business acumen
Ability to think strategically and tactically (detail-oriented)
Flexible and able to adapt to company growth and evolving responsibilities
Bachelor of Science in biological sciences or other relevant field of study.
Minimum of 15 years of relevant experience of which at least 5-10 years in a management role overseeing a laboratory environment with applicable clinical or commercial experience.
Knowledge of FDA and EMEA regulations and a working knowledge of root cause analysis.
Understanding of quality system applications, including the training, deviations, CAPA management, etc.
Experience in authoring, reviewing, and /or approving cGMP related documents (investigation, validation/qualification reports, SOPs etc.)
Experience in organizing and leading teams.
Experience participating in health authority inspections and/or client audits.
Understand requirements pertaining to aseptic manufacture of cellular products.
Strong understanding of Tech Transfer and Method Validation
Ability to work effectively with clients in a contract manufacturing environment.
Ability to recruit, lead and develop a high-performance manufacturing organization.
Capable to communicate in English
Strong written and oral communication skills

Nice To Haves

Advanced degree preferred.
Experience with environmental monitoring and aseptic processing is preferred.
Familiarity with the product development process for biological products is helpful.

Responsibilities

Ensure production support and cGMP compliance.
Manages laboratory resources (human resources and financial resources). Prepares and tracks budget and CapEx activities, including staff overtime and contractor budgets, within their scope of accountability and responsibility.
Oversee implementation and maintenance of QC functional group standards, instruments, methods, cGMP documents, sample handling, and applicable electronic systems (including LIMs).
Ensure analytical, micro and environmental monitoring programs adhere to current regulatory expectations.
Manage method validation to support technical transfer activities.
Ensure instrumentation is validated appropriately.
Ensure execution of functional group responsibilities within specifications, procedures, and policies and always maintains QC’s cGMP readiness.
Ensure QC support to Planning, Operations, Supply Chain and other department for timely release of the products to the clients.
Actively participates and enforces Global initiatives, SOPs and Safety Policies to ensure departmental compliance with company requirements and minimize laboratory accidents.
Manages robust laboratory investigations (analytical, micro and environmental monitoring OOS/OOT) to ensure root cause analysis and effectiveness checks are performed.
Provides strong leadership and guidance to laboratory operations and personnel.
Determine metrics to monitor lab performance and present these in Management Review meetings.
Conducts performance evaluations for QC laboratory personnel. Develop goals and manage individual development plan for lab employee.
Manages the training and data integrity programs for the laboratories.
Leads employees to meet the organization's expectations for productivity, quality, continuous improvement, and goal accomplishment.
Leads employees using a performance management and development processes to include goal setting, feedback, and performance development planning.
Provides effective performance feedback through employee recognition, rewards, and disciplinary action, with the assistance of Human Resources, as necessary.
Maintains employee work schedules including assignments, job rotation, training, vacations, and paid time off, coverage for absenteeism, and overtime scheduling.
Appropriately communicates organization information through department meetings, one-on-one meetings, and appropriate email, Instant Messaging (IM).
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.
Other duties as assigned.