(Senior) Director, CMC Quality Assurance (New York)
Proclinical Staffing, New York, New York, United States, 10261
(Senior) Director, CMC QA – Permanent – New York
Proclinical is seeking a (Senior) Director, CMC Quality Assurance for an emerging biotech company based in New York.
Primary Responsibilities: In this role, you will be responsible for the hands-on oversight of all Quality Assurance (QA) Good Manufacturing Practices (GMP) activities pertaining to the manufacture of drug product, analytical, packaging, labeling, distribution, and release of Clinical Supplies. You will own and lead the CMC Quality function across internal operations and external partners (CMOs/CROs/contract laboratories), including batch disposition, quality systems, change management, deviations, investigations, complaints, audits, and product release activities.
The position is based onsite in New York.
Skills & Requirements: B.S. or B.A. or higher degree (preferably in Life Science) with 10+ years of hands-on experience with increasing responsibility as a Quality Assurance Professional. Experience in small molecule development, batch release, and SOP drafting. Hands on experience implementing quality management systems in a GxP environment, and direct experience with FDA and other health authority inspections. Strong understanding and extensive knowledge of industry practices and global regulatory requirements (FDA, EMA, ICH) for clinical-stage products. Proven ability to build or scale quality systems in a dynamic environment. Prior experience managing CDMOs and external quality oversight strongly preferred. Experience in supporting IND/CTA/IMPD submissions and clinical supply release preferred.
The (Senior) Director, CMC QA will: Author, review and approve Standard Operating Procedures (SOPs), protocols, reports, specifications and other quality records for accuracy and compliance with all applicable regulations, guidance, and international standards. Review and provide quality input for CMC sections of product registration applications, and Investigational Medicinal Product Dossier (IMPD) submissions for drug substance, drug products analytical methods and stability studies. Develop and execute the CMC QA strategy aligned with company goals and regulatory expectations. Build, refine, and scale quality systems appropriate for a fast-growing biotech (e.g., change control, deviations, CAPA, document control, supplier management). Serve as the primary QA point of contact for CMC, manufacturing, analytical development, supply chain, and regulatory teams. Build and oversee cGMP Quality Management Systems, Batch Review and Release, Quality Control testing activities and disposition of packaging products to ensure compliance with internal procedures and global regulatory requirements (e.g., FDA, EMA, ICH).Manage quality audits at CMOs, CROs, contract labs including the implementation and monitoring of audit related corrective and preventative actions (CAPAs). Lead and facilitate thorough cGMP investigations for process deviations, out of specification test results, Out of Tolerance, and Out of Specifications events and identify root cause and CAPAs. Provide Quality Assurance input for failure analysis, problem solving, and risk assessment and mitigation activities related to the qualification and validation of the cGMP facility and equipment.
If you are having difficulty in applying or if you have any questions, please contact
Phu Huynh
at
(+1) 646-779-7961
or
p.huynh@proclinical.com
.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
Primary Responsibilities: In this role, you will be responsible for the hands-on oversight of all Quality Assurance (QA) Good Manufacturing Practices (GMP) activities pertaining to the manufacture of drug product, analytical, packaging, labeling, distribution, and release of Clinical Supplies. You will own and lead the CMC Quality function across internal operations and external partners (CMOs/CROs/contract laboratories), including batch disposition, quality systems, change management, deviations, investigations, complaints, audits, and product release activities.
The position is based onsite in New York.
Skills & Requirements: B.S. or B.A. or higher degree (preferably in Life Science) with 10+ years of hands-on experience with increasing responsibility as a Quality Assurance Professional. Experience in small molecule development, batch release, and SOP drafting. Hands on experience implementing quality management systems in a GxP environment, and direct experience with FDA and other health authority inspections. Strong understanding and extensive knowledge of industry practices and global regulatory requirements (FDA, EMA, ICH) for clinical-stage products. Proven ability to build or scale quality systems in a dynamic environment. Prior experience managing CDMOs and external quality oversight strongly preferred. Experience in supporting IND/CTA/IMPD submissions and clinical supply release preferred.
The (Senior) Director, CMC QA will: Author, review and approve Standard Operating Procedures (SOPs), protocols, reports, specifications and other quality records for accuracy and compliance with all applicable regulations, guidance, and international standards. Review and provide quality input for CMC sections of product registration applications, and Investigational Medicinal Product Dossier (IMPD) submissions for drug substance, drug products analytical methods and stability studies. Develop and execute the CMC QA strategy aligned with company goals and regulatory expectations. Build, refine, and scale quality systems appropriate for a fast-growing biotech (e.g., change control, deviations, CAPA, document control, supplier management). Serve as the primary QA point of contact for CMC, manufacturing, analytical development, supply chain, and regulatory teams. Build and oversee cGMP Quality Management Systems, Batch Review and Release, Quality Control testing activities and disposition of packaging products to ensure compliance with internal procedures and global regulatory requirements (e.g., FDA, EMA, ICH).Manage quality audits at CMOs, CROs, contract labs including the implementation and monitoring of audit related corrective and preventative actions (CAPAs). Lead and facilitate thorough cGMP investigations for process deviations, out of specification test results, Out of Tolerance, and Out of Specifications events and identify root cause and CAPAs. Provide Quality Assurance input for failure analysis, problem solving, and risk assessment and mitigation activities related to the qualification and validation of the cGMP facility and equipment.
If you are having difficulty in applying or if you have any questions, please contact
Phu Huynh
at
(+1) 646-779-7961
or
p.huynh@proclinical.com
.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.