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 SummaryThe Associate Director, Quality Operations - Client Delivery provides QA oversight of site manufacturing -- Master and Working Cell Banks, Viral Vectors, and Cell & Gene Therapy drug products. Ensure compliance with domestic and foreign regulatory requirements for cGMP. Participate in client meetings and directly interface with clients to provide data demonstrating quality performance and fulfillment of client requirements. Monitor, trend, and report on all aspects of Quality. Work with clients and cross-functionally to maintain compliance and meet site/program goals and objectives. Identify, implement and drive quality improvement projects and policies to reflect industry best practices.
Essential Functions and Responsibilities - Provide QA oversight of site manufacturing -- Master and Working Cell Banks, Viral Vectors, and Cell & Gene Therapy drug products.
- Ensure compliance with domestic and foreign regulatory requirements for cGMP.
- Back up department Director.
- Participate in client meetings and directly interface with clients to provide data demonstrating quality performance and fulfillment of client requirements.
- Monitor, trend, and report on all aspects of Quality.
- Work with clients and cross-functionally to maintain compliance and meet site/program goals and objectives.
- Lead and participate in site quality and process improvement initiatives, and project teams.
- Execute and approve site quality systems such as Change Controls, Investigations, Corrective and Preventive Actions, Product Quality Complaints, Document Management, etc.
- Ensure that investigations are completed in a thorough and timely fashion which meets customer commitments and comply with regulatory expectations.
- Ensure appropriate CAPA's are assigned, executed, and demonstrated to be effective with the intended remediation activity.
- Provide compliance support, expertise and training for the site. Provide direct and immediate support for internal, external and regulatory audits of site.
- Foster a spirit of collaboration, cooperation, honesty, and integrity while remaining flexible with customer focus.
- 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.
- 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.
- Performs other duties as assigned
Leadership Responsibility - Supports a diverse and inclusive culture and workforce, ensures compliance with laws, regulations, and company policies.
- 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.
Knowledge, Skills & Ability - Thorough working knowledge of domestic and global regulations, Quality System Management and Quality Assurance principles and practices. Strong knowledge of 21 CFR 210 and 211, 21 CFR Part 11, EU Guide to Good Manufacturing Practice.
- Experience in the development, streamlining, and optimization of Quality Systems
- Experience with electronic Quality Management Systems i.e. Master Control, Veeva, LIMS, etc
- Experience in writing, reviewing, and approving Investigations, CAPA, Change Control, SOPs, and Complaints
- Experience in leading cross-functional improvement projects
- Experience/participation in Health Authority inspections
- Ability to use judgment, clear problem-solving and decision-making skills.
- Ability to work independently and handle complex problems under limited supervision.
- Excellent organizational and interpersonal skills. Ability to communicate effectively with all levels of the organization.
- Proficient in Oral & Written communication skills
- Proficient in Microsoft (Excel, Word, Outlook, PowerPoint)
- Travel is required 5-10%, Domestic/International, Daily / Overnight
Education & Experience- BS/BA in related Science field; or combination of relevant experience & education
- 10 years relevant QA experience in the pharmaceutical industry and min 5 years managing people
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.
