Alliance/Partner Management, Auditing, Biology, Biotech and Pharmaceutical, Clinical Research, Communication Skills, Contract Research Organization (CRO), Document Change Management, Document Control, Documentation, Drug Development, Energy Efficiency, FDA (Food and Drug Administration), GCP (Good Clinical Practices), GLP (Good Laboratory Practices), GMP (Good Manufacturing Practices), Gene Therapy, GxP, ICH Regulations, Interpersonal Skills, Leadership, Maintain Compliance, Performance Management, Quality Assurance, Quality Management, Quality Metrics, Record Keeping, Regulations, Regulatory Compliance, Regulatory Requirements, Risk, Small Company, Standard Operating Procedures (SOP), Standards Development, Startup, Supplier Relationship Management (SRM), Systems Maintenance, Vendor/Supplier Relations
Job Title: Associate Director, Quality
Location: Hybrid
Reports to: Vice President, Head of Regulatory and Quality
Full/Part-Time: Full-Time
Regular/Temporary: Temporary 6 months, with possibility of 6-month extension
Job Summary
The Associate Director of Quality is responsible for managing quality assurance activities, providing strategic oversight of the implementation of a Quality Management System (QMS), and ensuring compliance with FDA, ICH, and other regulatory standards. This individual ensures compliance with GxP regulations (GLP, GMP, GCP as applicable) across our CROs. The successful candidate will establish quality frameworks from the ground up and lead quality initiatives that support the company''s pipeline from preclinical research through clinical development in a fast-paced, resource-conscious environment.
What You Will Do:
Quality Program Development
- Develop, implement, and maintain quality systems and procedures to ensure compliance with applicable regulations (GLP, GMP, GCP )
- Implement pragmatic quality approaches that balance compliance with operational efficiency
- Create quality culture and awareness across all organizational levels
- Excellent leadership, communication, and interpersonal skills
CRO Management & Strategic Partnerships
- Serve as the co-primary quality liaison for CDMO partnerships, overseeing quality agreements, audits, and ongoing compliance activities.
- Implement risk-based CRO oversight programs optimized for resource efficiency
- Build strong working relationships with CRO quality teams to ensure seamless collaboration
- Manage CRO performance with emphasis on speed, quality, and value delivery
Quality Systems & Documentation
- Develop, implement, and maintain quality systems and procedures to ensure compliance with applicable regulations (GLP, GMP, GCP.).
- Ensure proper documentation and record-keeping practices
- Lead development of standard operating procedures (SOPs) and work instructions
- Maintain document control and change management processes
- Review key quality documentation, including protocols, reports, SOPs, batch records, and laboratory data.
Technical Requirements and Skills:
Technical Skills
- Deep understanding of FDA, EMA, & ICH regulatory requirements
- Extensive knowledge of GMP, GLP, and GCP principles
- Experience with quality management systems and quality metrics
- Strong understanding of gene therapy development processes
- Experience with quality auditing and inspection processes
Qualifications
- Bachelor's degree in life sciences or related field required
- 10 + years of biotech industry experience
- Previous startup or small company experience highly preferred
- Experience building quality processes in early-stage development and understanding a fit-for-purpose approach
- Minimum 3-5 years of experience managing CROs and vendor relationships
Compensation: The salary range for this temporary position is $80.00 to $93.00 USD per hour. This salary range is an estimate, and the actual salary may vary based on various factors, including, without limitation, individual education, experience, tenure, skills, and abilities, as well as internal equity and alignment with market data, including potential adjustments for geographic location.