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Associate Director, Quality
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BioSpace Job Title : Associate Director, Quality Location : Hybrid Reports to : Vice President, Head of Regulatory Full/Part-Time : Full-Time Regular/Temporary : Temporary 6 months, with possibility of 6-month extension
Overview The Associate Director of Quality is responsible for leading and managing quality assurance activities by providing strategic oversight of Contract Research Organizations (CROs) to support implementation of a Quality Management System (QMS), ensuring compliance with FDA, ICH, and other regulatory standards. This individual ensures compliance with GxP regulations (GLP, GMP, GCP as applicable) and collaborates closely with cross-functional teams to ensure product development, testing, and manufacturing meet regulatory standards and company quality expectations. 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.
Responsibilities
Develop, implement, and maintain quality systems and procedures to ensure compliance with applicable regulations (GLP, GMP, ICH, FDA, EMA, etc.).
Lead quality risk assessments with a focus on resource optimization and critical path activities.
Implement pragmatic quality approaches that balance compliance with operational efficiency.
Create quality culture and awareness across all organizational levels.
Serve as the 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.
Develop, implement, and maintain quality systems and procedures to ensure compliance with applicable regulations (GLP, GMP, ICH, FDA, EMA, etc.).
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 and approve key quality documentation, including protocols, reports, SOPs, batch records, and laboratory data.
Apply deep understanding of FDA, ICH, and international regulatory requirements and GMP/GLP/GCP principles; utilize quality management systems and metrics; and apply risk management methodologies (ICH Q9, Q10).
Qualifications
Bachelor’s degree in life sciences or related field required.
8+ years of pharmaceutical/biotech industry experience.
Experience building quality programs and processes from early stages; prior startup or small company experience highly preferred.
Minimum 3-5 years of experience managing CROs and vendor relationships.
Experience with novel therapeutic modalities (biologics, cell/gene therapy, etc.).
Excellent leadership, communication, and interpersonal skills.
Proficiency in regulatory understanding and quality auditing/inspection processes.
Compensation 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 factors including education, experience, tenure, skills, abilities, internal equity, and market data, including potential adjustments for geographic location.
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Associate Director, Quality
role at
BioSpace Job Title : Associate Director, Quality Location : Hybrid Reports to : Vice President, Head of Regulatory Full/Part-Time : Full-Time Regular/Temporary : Temporary 6 months, with possibility of 6-month extension
Overview The Associate Director of Quality is responsible for leading and managing quality assurance activities by providing strategic oversight of Contract Research Organizations (CROs) to support implementation of a Quality Management System (QMS), ensuring compliance with FDA, ICH, and other regulatory standards. This individual ensures compliance with GxP regulations (GLP, GMP, GCP as applicable) and collaborates closely with cross-functional teams to ensure product development, testing, and manufacturing meet regulatory standards and company quality expectations. 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.
Responsibilities
Develop, implement, and maintain quality systems and procedures to ensure compliance with applicable regulations (GLP, GMP, ICH, FDA, EMA, etc.).
Lead quality risk assessments with a focus on resource optimization and critical path activities.
Implement pragmatic quality approaches that balance compliance with operational efficiency.
Create quality culture and awareness across all organizational levels.
Serve as the 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.
Develop, implement, and maintain quality systems and procedures to ensure compliance with applicable regulations (GLP, GMP, ICH, FDA, EMA, etc.).
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 and approve key quality documentation, including protocols, reports, SOPs, batch records, and laboratory data.
Apply deep understanding of FDA, ICH, and international regulatory requirements and GMP/GLP/GCP principles; utilize quality management systems and metrics; and apply risk management methodologies (ICH Q9, Q10).
Qualifications
Bachelor’s degree in life sciences or related field required.
8+ years of pharmaceutical/biotech industry experience.
Experience building quality programs and processes from early stages; prior startup or small company experience highly preferred.
Minimum 3-5 years of experience managing CROs and vendor relationships.
Experience with novel therapeutic modalities (biologics, cell/gene therapy, etc.).
Excellent leadership, communication, and interpersonal skills.
Proficiency in regulatory understanding and quality auditing/inspection processes.
Compensation 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 factors including education, experience, tenure, skills, abilities, internal equity, and market data, including potential adjustments for geographic location.
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