Quality Manager

Job Description

Job Description

The Quality Manager will be responsible for establishing, implementing, maintaining, and continuously improving CuriRx's Quality Management System to ensure compliance with applicable regulatory requirements, industry standards, client expectations, and internal quality objectives.

This role will provide strategic and operational leadership for quality assurance and quality control activities across research, analytical testing, process development, and manufacturing operations. The successful candidate will lead quality initiatives related to ISO 9001, GMP compliance, vendor qualification, audits, CAPA management, validation programs, inspection readiness, document control, training, and quality risk management.

The ideal candidate is a proactive leader and critical thinker with demonstrated experience building and managing quality systems within a CRO, CDMO, biopharmaceutical, or regulated laboratory environment. This individual must be capable of driving a quality-focused culture while supporting business growth and operational excellence.

Key Responsibilities

Quality Management System (QMS) Leadership

• Develop, implement, maintain, and continuously improve the company's Quality Management System (QMS).
• Establish and maintain quality policies, procedures, work instructions, forms, and quality records.
• Ensure compliance with applicable FDA, ICH, USP, OECD, ISO, and cGMP regulations and industry standards.
• Lead Management Review meetings and develop quality performance metrics and Key Performance Indicators (KPIs).
• Drive quality culture initiatives throughout the organization.

Quality Assurance

• Oversee all QA activities, including document review, approval processes, deviation management, change control, CAPA, and quality risk management.
• Review and approve SOPs, protocols, reports, specifications, batch records, and validation documentation.
• Perform quality oversight for research, development, analytical testing, and manufacturing operations.
• Authorize hold-point releases and quality approvals following completion of required quality activities.
• Ensure compliance with data integrity principles and Good Documentation Practices (GDP).

Quality Control Oversight

• Provide oversight of analytical testing, laboratory controls, investigations, and data review activities.
• Support qualification and validation activities for analytical methods, laboratory equipment, computerized systems, utilities, and facilities.
• Ensure proper handling of out-of-specification (OOS), out-of-trend (OOT), deviations, and non-conformance investigations.
• Review QC performance trends and implement continuous improvement initiatives.

Audits, Compliance & Inspection Readiness

• Plan, conduct, and manage internal audits, supplier audits, and external audits.
• Maintain inspection readiness for client, regulatory, and certification audits.
• Serve as the primary quality representative during client and regulatory inspections.
• Lead responses to audit observations and regulatory findings.
• Coordinate effectiveness checks and closure of corrective actions.

Risk Management & Continuous Improvement

• Implement risk-based quality management and risk assessment methodologies.
• Develop and manage CAPA programs, root cause investigations, and mitigation strategies.
• Identify opportunities to improve compliance, efficiency, and operational effectiveness.
• Implement quality systems that support company growth and future commercial manufacturing capabilities.

Supplier & Vendor Quality Management

• Establish and maintain supplier qualification programs.
• Perform supplier evaluations, audits, and annual reviews.
• Monitor quality agreements and vendor performance metrics.
• Ensure subcontractors and service providers meet quality and regulatory requirements.

Training & Leadership

• Lead, mentor, and develop quality personnel and cross-functional teams.
• Develop and manage GxP training programs and competency assessments.
• Promote a culture of accountability, compliance, and continuous improvement.
• Provide quality guidance and support to all departments.

Documentation & Records Management

• Oversee document control systems and quality records management.
• Ensure proper retention, archiving, and retrieval of paper and electronic records.
• Maintain compliance with data integrity and electronic record requirements.
• Support implementation and management of electronic Quality Management Systems (eQMS).

Business & Operational Support

• Support client proposals, technical due diligence, and quality assessments.
• Participate in technology transfers, process development reviews, and manufacturing readiness programs.
• Monitor quality-related budgets, resources, and project timelines.
• Support strategic initiatives associated with CuriRx's growth as a CDMO.

Required Qualifications

Education

• Bachelor's degree in Biotechnology, Biochemistry, Biology, Chemistry, Pharmaceutical Sciences, Engineering, or a related scientific discipline.
• Master's degree preferred.

Experience

• Minimum of 10 years of quality assurance and/or quality control experience in the biotechnology, pharmaceutical, CRO, CDMO, or life sciences industry.
• Minimum of 5 years in a leadership, supervisory, or management role .
• Demonstrated experience implementing and managing Quality Management Systems in regulated environments.
• Experience supporting GMP, GLP, GCP, and/or ISO-compliant operations.
• Experience managing audits, CAPAs, deviations, change controls, and validation programs.

Technical Knowledge

• Strong knowledge of FDA, ICH, USP, ISO, and cGMP regulations and guidelines.
• Experience with supplier qualification and quality agreement management.
• Knowledge of laboratory operations, analytical testing, and biologics development processes.
• Familiarity with validation, qualification, and computerized system compliance.
• Experience using eQMS, LIMS, and document management systems preferred.

Core Competencies

• Strong leadership and people management skills
• Strategic thinking and problem-solving abilities
• Excellent written and verbal communication skills
• Exceptional attention to detail and organizational skills
• Ability to manage multiple priorities in a fast-paced environment
• Strong analytical and risk assessment capabilities
• Customer-focused mindset balancing compliance and business needs
• Commitment to diversity, inclusion, teamwork, and professional integrity

CuriRx, Inc. was founded in 2012, a contract research, development, and manufacturing organization (CRDMO) specializing in biologics, gene therapy, cell therapy, and advanced drug delivery solutions. Our vision is to create new standards of care in therapeutic areas with high unmet medical needs. We do this by partnering with our clients to provide innovative development solutions for pharmaceutics, biopharmaceutics, vaccines, generics, and biosimilars. CuriRx focuses on formulation and lyophilization development of biologics, small molecule, analytical development, and preclinical manufacturing of biologics. The company provides end-to-end services including process development, analytical testing, formulation development, GMP manufacturing support, and regulatory assistance for biotechnology and pharmaceutical clients.

Company Description

CuriRx, Inc. was founded in 2012, a contract research, development, and manufacturing organization (CRDMO) specializing in biologics, gene therapy, cell therapy, and advanced drug delivery solutions. Our vision is to create new standards of care in therapeutic areas with high unmet medical needs. We do this by partnering with our clients to provide innovative development solutions for pharmaceutics, biopharmaceutics, vaccines, generics, and biosimilars. CuriRx focuses on formulation and lyophilization development of biologics, small molecule, analytical development, and preclinical manufacturing of biologics. The company provides end-to-end services including process development, analytical testing, formulation development, GMP manufacturing support, and regulatory assistance for biotechnology and pharmaceutical clients.