HireMinds 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 support of the 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.