Minaris Advanced Therapies · 2 hours ago
Director of Compliance, Quality
Allendale, NJ
Full-time
Onsite
Director/Executive
14+ years expMinaris Advanced Therapies is a global leader in cell and gene therapy development, manufacturing, and testing. The Director of Quality Compliance is responsible for ensuring that the organization maintains a robust, inspection-ready state across all GMP operations, providing strategic oversight of quality systems and regulatory compliance.
BiotechnologyHealth CareManufacturing
Responsibilities
Lead the development, implementation, and continuous improvement of the Compliance & Inspection Readiness Program, ensuring proactive identification and mitigation of compliance risks
Direct and oversee regulatory inspection management, and follow-up responses, ensuring timely closure of findings and sustainable remediation
Provide oversight of investigations, root cause analysis, CAPA planning, and effectiveness verification, ensuring systemic issues are resolved and recurrence prevented
Govern change control management, facilitating cross-functional risk assessments and approvals to maintain product quality and regulatory compliance
Monitor, assess, and communicate compliance metrics and trends to senior leadership, ensuring visibility of key risks and progress
Partner with manufacturing, validation, and development teams to ensure compliance is embedded in all operations
Manage, mentor, and develop compliance and quality staff, fostering a culture of accountability, technical excellence, and continuous learning
Serve as a primary liaison with regulatory agencies during inspections, and information requests
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
Anticipates compliance risks and positions the organization ahead of regulatory expectations
Builds trust across functions and inspires a culture of compliance ownership
Ensures timely decision-making and effective issue resolution
Invests in training, coaching, and growing future compliance leaders
Qualification
Required
Bachelor's degree and or masters degree in pharmaceutical science, biology, chemistry, or related science
Minimum 14 years of progressive GMP biotech experience, including leadership roles in both Manufacturing and Quality
Proven success in regulatory inspections (FDA, EMA, TGA, others) and product approvals for innovative biologics or cell & gene therapies
Strong knowledge of global GxP regulations, ICH guidelines, and advanced therapy regulatory requirements
Expertise in QMS systems (e.g., TrackWise/NextGen, Veeva, SAP, LIMS, MES, Oracle, BMRAM)
Demonstrated experience in investigations, CAPA, change control, and inspection readiness programs
Strong leadership, influencing, and team-building skills with the ability to manage cross-functional stakeholders
Exceptional written and verbal communication skills; ability to represent the company effectively to regulators and clients
Experience with direct Health Authority communication and providing follow up responses
Experience with inspection related training, inspection readiness and management
Experience supporting audits
Experience with risk management, investigation, CAPA, and change control review and approval
Experience presenting critical findings to leadership
Benefits
Medical insurance
Vision insurance
Dental insurance
401(k)
Paid time off
Tuition assistance
And more
Company
Minaris Advanced Therapies
Minaris Advanced Therapies is a global cell and gene therapy (CGT) CDMO and a multimodality biosafety testing provider.
1001-5000 employees
H1B Sponsorship
Minaris Advanced Therapies has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2022 (1)
2021 (1)
Funding
Current Stage
Late StageTotal Funding
unknown2025-01-07Acquired
Leadership Team
William Burckardt
Chief Financial Officer, North America
Enid Agosto
Senior Administrative Assistant to CFO and Head of People & Organizational Development
Recent News
Seattle TechFlash
2025-08-18
2025-07-22
Company data provided by crunchbase