ImmunoGen is a clinical-stage biotechnology company that develops targeted cancer therapeutics using its proprietary antibody-drug conjugate (ADC) technology. ImmunoGen’s lead product candidate, mirvetuximab soravtansine, is being advanced to a Phase 3 trial for FRα-positive platinum-resistant ovarian cancer, and is in Phase 1b/2 testing in combination regimens for earlier-stage disease. ImmunoGen’s ADC technology is used in Roche's marketed product, Kadcyla, in three other clinical-stage ImmunoGen product candidates, and in programs in development by partners Amgen, Bayer, Biotest, CytomX, Lilly, Novartis, Sanofi and Takeda.
Post : SR. MANAGER, GCP/GLP QA
Job Description
- Conduct internal and external report/document, data, clinical site, vendor/CRO, and internal process audits, as needed.
- Assist in the conduct of Non-clinical and Clinical vendor/subcontractor/site qualification audits.
- Assist in assessing Non-clinical and Clinical laboratories adherence to GLP and GCLP and applicable regulations.
- Ensure internal and external (clinical sites/vendors/CROs) adherence to GCP and applicable regulations.
- Assist in the writing and/or reviewing of SOPs for the GCP compliance program, quality documentation such as quality agreementsand review various clinical study documentation such as study protocols, ICFs, monitoring plans, clinical study reports, etc.
- Track deviations and CAPAs through completion.
- Assist in the development and tracking of quality metrics.
- Assist in evaluating and investigating clinical study non-compliance, quality events, incidents, queries, and complaints.
- Communicate any critical compliance risks noted from these activities to QA management.
Candidate Profile
• BS/BA in field of science such as chemistry, microbiology, biology and biochemistry or BS in a related science field.
• Three - five years in a GCP/GLP environment, and at least three years working in a Quality Assurance role supporting GCP/GLP compliance.
• Experience in leading and conducting clinical site, vendor/CRO, and internal process audits.
• Good working knowledge of GCP and GLP guidance and regulations. .
• Proficient in Microsoft Office suite (Word, Excel, Powerpoint).
• Proven ability to identify and effectively resolve quality issues and gaps; practical approach to problem solving.
• Ability to work independently and within a group setting and to interact effectively with Non-clinical, Clinical pharmacology and Clinical functions.
• Strong communication skills (oral, written, and interpersonal)
• Excellent attention to detail, time management, and investigative skills as well as the ability to manage multiple priorities.
• Demonstrated good judgement and decision-making experience
• Demonstrates flexibility in dealing with change and diversity
• Relationship building skills.
Additional Information
Experience : 3 - 5 years
Qualification : BS/BA
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Reg. Affairs
End Date : 10th January, 2018
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