Head of Quality and Compliance

Level: Head/ VP, Leadership Team Member

Reports to: Chief Executive Officer

Location: New Jersey, Fully on-site

Position Summary:

The Head/VP of Quality and Compliance will be a pivotal member of the senior leadership team, reporting directly to the CEO. This role will be responsible for overseeing and leading the entire Quality and Compliance organization at BioCentriq, a CDMO specializing in Cell and Gene Therapy. The individual will ensure the highest standards of quality and regulatory compliance across all functions, including Quality Systems and Compliance, Quality Control, QC-Microbiology, and Quality Operations. A key responsibility will be managing the quality aspects involved in relocating the GMP facility from one building to another, ensuring seamless continuity of operations and compliance

Key Responsibilities:

Leadership and Strategic Oversight: Provide strategic leadership and direction for all Quality and Compliance functions, including Quality Systems, Quality Control (QC), QC-Microbiology, Quality Operations, and Compliance. Drive the development and implementation of a robust quality culture throughout the organization.

Facility Relocation: Lead the quality and compliance strategy related to relocating the GMP facility, ensuring that all quality systems and processes are effectively transferred and validated in the new location. Manage risk assessments, change controls, and all necessary regulatory approvals to ensure a smooth transition.

Quality Systems Management: Develop, implement, and continuously improve quality systems such as document control, training, supplier quality management, and audits to maintain compliance with GMP and GLP standards.

Regulatory Compliance and Inspection Readiness: Ensure adherence to cGMP, GLP, and other regulatory standards. Serve as a key contact for regulatory agencies and lead or support regulatory inspections and audits.

Quality Control and Microbiology: Oversee Quality Control activities, including analytical testing, raw material testing, stability studies, environmental monitoring, and method validation. Manage QC-Microbiology functions internally and through external partnerships.

Cross-Functional Collaboration: Collaborate closely with manufacturing, process development, R&D, IT, and other functions to build a robust Quality organization that aligns with the company’s strategic objectives.

Team Development and Management: Build, develop, and lead a high-performing quality team, fostering a culture of quality excellence and continuous improvement. Provide mentorship and professional development opportunities to team members.

MP Compliance Programs: Develop and implement comprehensive GMP compliance programs, including policies, procedures, training, and audit protocols. Ensure compliance with regulations such as 21 CFR Part 210 and 211.

Data Integrity and eQMS Implementation: Develop and maintain the Data Integrity Program. Lead or support the selection and implementation of new electronic Quality Management Systems (eQMS).

Client and Vendor Management: Develop and manage Quality Agreements with clients and oversee quality interactions with vendors and third-party service providers. Ensure that client needs and expectations are met with the highest standards of quality and compliance.

Qualifications & Requirements:

• A degree in biological sciences, with an MS preferred.
• 10+ years of technical experience in a GMP pharmaceutical or biologics manufacturing environment, with a preference for experience in Cell and Gene Therapy.
• Proven experience in both Quality Assurance and Quality Control.
• Experience working in a CDMO environment is required.
• 5+ years in a senior leadership role within Quality management.
• Demonstrated experience in managing quality systems and regulatory compliance for a facility move or similar large-scale project.
• Strong knowledge of cGMP, GLP, and regulatory requirements from agencies such as the FDA, EMA, ICH, and other global regulators.
• Experience in leading regulatory inspections and interacting with health authorities.
• Excellent problem-solving skills and the ability to make objective, unbiased decisions with incomplete information.
• High degree of emotional intelligence, with strong listening skills and exceptional written and verbal communication abilities.
• Ability to lead cross-functional teams and drive a culture of quality and compliance across the organization.
• Experience working in a high-growth, fast-paced environment.

To apply, click the button below or email your resume and the position(s) you’re interested in to recruiter@biocentriq.com.