HireMinds
Director Quality Assurance (On-site GMP)
HireMinds, Watertown, Massachusetts, us, 02472
Director Quality Assurance (On-site GMP)
Location: Watertown, MAOn-site RequirementHireMinds is seeking your expertise in Quality as an experienced Associate Director/Director of Quality Assurance to lead quality programs in a dynamic cGMP clinical-stage manufacturing environment. In this role, you'll work with an on-site presence in the support of production of cutting-edge radiopharmaceutical therapies for unmet needs in oncology. You'll work with a tight-knit biotech team with backing from pharmaceutical partners. If this sounds like an exciting opportunity to further your career, apply today or contact the HireMinds Biotech team.You'll Be Responsible For:
Operational QA Support: Provide onsite QA oversight for aseptic drug product manufacturing, including drafting and reviewing batch records, releasing raw materials and finished products, and managing deviations, CAPAs, and change controls.Metrology Program Support: Develop and review IQ/OQ/PQ documentation for instruments, equipment, and facilities. Oversee scheduling of vendor qualifications and preventive maintenance.GxP Training: Design and deliver GxP training programs (GMP, GCP, GLP, CSV), manage training records, and assign curricula.Quality Management System (QMS): Develop and review SOPs related to quality assurance, manufacturing, and quality control.Auditing & Vendor Management: Conduct internal GxP audits, source data verification, vendor qualification assessments, and risk evaluations.Regulatory Compliance: Support regulatory submissions by reviewing technical documents such as technology transfer protocols, process validation reports, and stability studies.Metrics & Reporting: Collect and report quality assurance metrics during Quality Management Review meetings.Documentation Management: Maintain electronic and paper-based archives of quality documents.You'll Bring With You:
BS/MS in engineering or scientific manufacturing disciplines.Minimum 5 years in cGMP aseptic manufacturing and quality control within the pharmaceutical or biotech industry.Familiarity with global QMS standards (e.g., EU GMP Vol 4, Annexes 1 & 3, 21 CFR 210-212, Part 11, ICH, USP).Experience in QA for GCP, GLP, CSV compliance, or radiopharmaceuticals is a plus.Strong cross-functional collaboration abilities.Commitment to data integrity and adherence to compliance requirements.Passion for making an impact in the oncology field for patients in need.
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Location: Watertown, MAOn-site RequirementHireMinds is seeking your expertise in Quality as an experienced Associate Director/Director of Quality Assurance to lead quality programs in a dynamic cGMP clinical-stage manufacturing environment. In this role, you'll work with an on-site presence in the support of production of cutting-edge radiopharmaceutical therapies for unmet needs in oncology. You'll work with a tight-knit biotech team with backing from pharmaceutical partners. If this sounds like an exciting opportunity to further your career, apply today or contact the HireMinds Biotech team.You'll Be Responsible For:
Operational QA Support: Provide onsite QA oversight for aseptic drug product manufacturing, including drafting and reviewing batch records, releasing raw materials and finished products, and managing deviations, CAPAs, and change controls.Metrology Program Support: Develop and review IQ/OQ/PQ documentation for instruments, equipment, and facilities. Oversee scheduling of vendor qualifications and preventive maintenance.GxP Training: Design and deliver GxP training programs (GMP, GCP, GLP, CSV), manage training records, and assign curricula.Quality Management System (QMS): Develop and review SOPs related to quality assurance, manufacturing, and quality control.Auditing & Vendor Management: Conduct internal GxP audits, source data verification, vendor qualification assessments, and risk evaluations.Regulatory Compliance: Support regulatory submissions by reviewing technical documents such as technology transfer protocols, process validation reports, and stability studies.Metrics & Reporting: Collect and report quality assurance metrics during Quality Management Review meetings.Documentation Management: Maintain electronic and paper-based archives of quality documents.You'll Bring With You:
BS/MS in engineering or scientific manufacturing disciplines.Minimum 5 years in cGMP aseptic manufacturing and quality control within the pharmaceutical or biotech industry.Familiarity with global QMS standards (e.g., EU GMP Vol 4, Annexes 1 & 3, 21 CFR 210-212, Part 11, ICH, USP).Experience in QA for GCP, GLP, CSV compliance, or radiopharmaceuticals is a plus.Strong cross-functional collaboration abilities.Commitment to data integrity and adherence to compliance requirements.Passion for making an impact in the oncology field for patients in need.
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