Director of Compliance, Quality

Minaris•Allendale, NJ

3d•Remote

About The Position

The Director of Quality Compliance is responsible for ensuring that the organization maintains a robust, inspection-ready state across all GMP operations. This role provides strategic oversight of quality systems, regulatory compliance, and inspection readiness for cell and gene therapy manufacturing and testing operations. The Director will serve as a key partner to senior leadership, ensuring global regulatory requirements (FDA, EMA, TGA, and other health authorities) are consistently met and that quality is embedded as a driver of operational excellence.

Requirements

Experience with the following:
direct Health Authority communication and providing follow up responses.
inspection related training, inspection readiness and management.
supporting audits.
With risk management, investigation, CAPA, and change control review and approval.
presenting critical findings to leadership.
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.

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.