Minaris Regenerative Medicine GmbH
Director of Compliance, Quality
Minaris Regenerative Medicine GmbH, Allendale, New Jersey, us, 07401
Allendale, 75 Commerce Drive, Allendale, New Jersey, United States of America
Job Description Posted Monday, January 26, 2026 at 6:00 AM
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 Summary
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.
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.
Leadership Responsibility
Strategic and Proactive : Anticipates compliance risks and positions the organization ahead of regulatory expectations.
Collaborative Leader : Builds trust across functions and inspires a culture of compliance ownership.
Decisive and Accountable : Ensure timely decision‑making and effective issue resolution.
Developer of Talent : Invests in training, coaching, and growing future compliance leaders.
Knowledge, Skills & Ability
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.
Education & Experience
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.
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.
Special Working Conditions:
Remote. 40% Travel
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.
The estimated base salary range for each open position based in the United States of America is included for all our current openings. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location where the role is to be performed, internal equity, and alignment with market data. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) as part of the compensation package. 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.
#J-18808-Ljbffr
Job Description Posted Monday, January 26, 2026 at 6:00 AM
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 Summary
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.
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.
Leadership Responsibility
Strategic and Proactive : Anticipates compliance risks and positions the organization ahead of regulatory expectations.
Collaborative Leader : Builds trust across functions and inspires a culture of compliance ownership.
Decisive and Accountable : Ensure timely decision‑making and effective issue resolution.
Developer of Talent : Invests in training, coaching, and growing future compliance leaders.
Knowledge, Skills & Ability
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.
Education & Experience
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.
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.
Special Working Conditions:
Remote. 40% Travel
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.
The estimated base salary range for each open position based in the United States of America is included for all our current openings. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location where the role is to be performed, internal equity, and alignment with market data. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) as part of the compensation package. 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.
#J-18808-Ljbffr