Bachelor's degree in Life Sciences, Engineering, or related scientific discipline.
10+ years' of experience in Quality Assurance, Quality Control, and/or Regulatory Affairs within regulated advanced therapeutic industries.
Experience in developing and maintaining GMP-compliant quality systems in clinical-stage biotech.
Strong knowledge of FDA, EMA, GxP regulations and experience managing audits.
Track record of supporting regulatory inspections and filings, ensuring commercial readiness.
Excellent leadership and communication skills with the ability to influence across all organizational levels.
Responsibilities
Lead the management of a Quality Management System overseeing key quality processes.
Ensure compliance with applicable FDA, EMA, and GxP regulations for internal operations.
Review and approve various quality records and documentation.
Manage the quality supplier program and oversee vendor qualification and audits.
Drive readiness for inspections and lead audit responses and quality improvement initiatives.
Develop and execute analytical and microbiological quality control strategies.
Establish quality metrics and continuous improvement programs for product quality.
Benefits
Flexible work schedule to accommodate a fast-paced environment.
Opportunity to work in a cutting-edge therapeutic sector.
Gain experience in regulatory filings and inspections from a biotech perspective.
Engagement with cross-functional teams thus broadening professional expertise.
Full Job Description
Job Type
Full-time
Description
Quality Assurance
Lead and maintain a phase-appropriate Quality Management System (QMS) overseeing core quality processes including but not limited to deviations, CAPAs, change controls, document management, training, complaints and risk management.
Provide GMP and GTP quality oversight of internal operations ensuring compliance with FDA, EMA, all applicable GxP regulations, select state regulations and accrediting bodies
Review and approve quality records, including investigations, batch documentation, validation packages and product disposition.
Manage and oversee the quality supplier program, quality agreements, vendor qualification activities and routine external audits.
Drive inspection readiness and lead all internal/external audits, responses to regulatory inspections, partner audits and quality improvement initiatives.
Quality Control
Develop and execute analytical and microbiological quality control strategy supporting product development, manufacturing and clinical/investigational supply.
Oversee internal and external laboratory activities, including routine product testing, product visual inspection, microbiological testing, raw material testing and overall laboratory compliance programs.
Ensure timely execution of product testing, visual inspection and review of analytical and microbiological data supporting raw material qualification, batch release, stability programs and specification management.
Management of the environmental monitoring program, cleanroom sampling and contamination control strategies.
Oversight of external contract testing organizations.
Establish quality metrics, trending programs and continuous improvement initiatives to ensure product quality and compliance.
Regulatory
Develop and execute regulatory strategies supporting process development, manufacturing operations and commercialization.
Lead preparation, submission and maintenance of regulatory filings, including INDs, amendments, annual reports, meeting packages and designation applications.
Serve as the primary liaison with regulatory authorities, coordinating responses and agency communications.
Monitor emerging regulatory requirements and industry trends assessing impact to business. Drive compliance update activities.
Partner with cross-functional teams to ensure regulatory requirements are assessed and incorporated into development, clinical and manufacturing planning.
Requirements
Minimum Qualifications (Must have)
Bachelor's degree in Life Sciences, Engineering, or related scientific discipline
10+ years' of progressive experience in Quality Assurance, Quality Control, and/or Regulatory Affairs within regulated advanced therapeutic industries
Demonstrated experience developing, maintaining and leading GMP-compliant quality systems and regulatory programs in a clinical-stage biotechnology environment
Strong working knowledge of FDA, EMA, GxP and any applicable regulatory requirements governing product development and manufacturing. Expertise leading and managing internal and external audits of these regulations
Successful track record supporting regulatory inspections, regulatory filings, agency communications, commercial readiness activities or product approvals.
Strong leadership, adaptability, communication and cross-functional collaboration skills with the ability to influence stakeholders at all organizational levels
Preferred Qualifications
Direct experience supporting cell therapy, gene therapy, tissue engineering, regenerative medicine and/or biologics
Experience in a fast-paced, scientific, start-up environment
Dynamic individual with the ability to communicate and engage others.
Independent and self-starting.
Eager and adaptable.
Working Conditions
Position primarily supports classified laboratory environments.
May be required to gown aseptically.
Open office environment outside of laboratory zones
Fast paced, start-up environment which may periodically require work beyond standard business hours. Flexible schedule.
