Director, Quality Compliance

Minaris Advanced Therapies; Allendale (NJ); On-site; USD 140,000 - 210,000; Full time

Job summary

Minaris Advanced Therapies is seeking a Director of Compliance to ensure an inspection-ready GMP environment across cell and gene therapy operations. You will lead risk-based compliance programs, guide regulatory interactions, and partner with senior leadership to embed quality in all processes.

The role requires extensive GMP biotech leadership, deep knowledge of GxP and ICH guidelines, and hands-on management of CAPA, audits, and change control across manufacturing and development teams.

Qualifications

• Bachelor's or master's degree in pharmaceutical science, biology, chemistry, or related science.
• Minimum 14 years of progressive GMP biotech experience, including leadership roles in 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 (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 Compliance & Inspection Readiness Program and mitigate compliance risks.
• Oversee regulatory inspection management and timely closure of findings.
• Provide oversight of investigations, CAPA, and root cause analysis.
• Govern change control management and cross-functional risk assessments.
• Communicate compliance metrics and trends to senior leadership.
• Partner with manufacturing, validation, and development teams to embed compliance.
• Mentor and develop compliance and quality staff.
• Serve as liaison with regulatory agencies during inspections and information requests.
• Maintain full-time attendance and professional conduct.

Skills

Health Authority communication

Inspection readiness

Regulatory audits

CAPA investigations

Change control

Leadership

Regulatory liaison

Education

Bachelor's degree in pharmaceutical science/biology/chemistry

Master's degree in pharmaceutical science/related field

Tools

TrackWise/NextGen

Veeva

SAP

LIMS

MES

Oracle

BMRAM

Job description

The Director of 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 regulatory requirements (FDA, EMA, TGA, and other health authorities) are consistently met and that quality is embedded as a driver of operational excellence.

Essential Functions and 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.
• 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.
• 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.

Knowledge, Skill & Ability

Experience with the following:

• Direct Health Authority communication andproviding follow-upresponses.
• Inspection related training,inspectionreadinessand management.
• Supporting audits.
• Withrisk management, investigation, CAPA,andchange control review and approval.presenting critical findings to leadership.

Education & Experience

• Bachelor's degree and or master's 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.