BioTalent
Overview
Summary:
Seeking a hands-on Quality Manager to lead day-to-day quality operations in a GMP pharmaceutical manufacturing environment. This role oversees QA and QC activities to ensure products meet all regulatory, quality, and safety standards while supporting continuous improvement initiatives. Responsibilities Manage site Quality Management System (QMS) in compliance with cGMP, FDA, EMA, and ICH requirements. Oversee QA and QC functions, including batch record review, product release, and stability program management. Coordinate and lead internal, external, and regulatory audits; ensure timely follow-up and closure of findings. Supervise deviation, CAPA, and change control processes to maintain compliance and operational efficiency. Collaborate with manufacturing, supply chain, and R&D to support quality in all stages of production. Monitor quality metrics and identify opportunities for process improvement. Train, mentor, and develop quality team members to foster a compliance-focused culture.
Qualifications
Bachelors degree in Life Sciences, Chemistry, Engineering, or related field. 58 years of pharmaceutical quality experience, with at least 2 years in a supervisory role. Strong knowledge of cGMP, FDA, and international pharmaceutical regulations. Experience with audits, inspections, and QA/QC operations. Excellent problem-solving, organizational, and communication skills.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing
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Summary:
Seeking a hands-on Quality Manager to lead day-to-day quality operations in a GMP pharmaceutical manufacturing environment. This role oversees QA and QC activities to ensure products meet all regulatory, quality, and safety standards while supporting continuous improvement initiatives. Responsibilities Manage site Quality Management System (QMS) in compliance with cGMP, FDA, EMA, and ICH requirements. Oversee QA and QC functions, including batch record review, product release, and stability program management. Coordinate and lead internal, external, and regulatory audits; ensure timely follow-up and closure of findings. Supervise deviation, CAPA, and change control processes to maintain compliance and operational efficiency. Collaborate with manufacturing, supply chain, and R&D to support quality in all stages of production. Monitor quality metrics and identify opportunities for process improvement. Train, mentor, and develop quality team members to foster a compliance-focused culture.
Qualifications
Bachelors degree in Life Sciences, Chemistry, Engineering, or related field. 58 years of pharmaceutical quality experience, with at least 2 years in a supervisory role. Strong knowledge of cGMP, FDA, and international pharmaceutical regulations. Experience with audits, inspections, and QA/QC operations. Excellent problem-solving, organizational, and communication skills.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr