What are the responsibilities and job description for the Senior Director, GCP/GLP Quality Assurance 2057513 position at Stratacuity: Proven Scientific Placement?
Location:Watertown MA (Onsite)
Science/Focus:Immunological Diseases
Job Overview:This role will lead the Clinical Quality strategy, aligning with regulatory standards, managing quality programs and audits, and providing compliance guidance for clinical and non-clinical development.
Primary Job Responsibilities:
- Develop a Clinical Quality strategy aligning with organizational goals and regulatory standards.
- Implement a targeted audit strategy for clinical and non-clinical studies.
- Provide expert compliance advice within clinical study teams for quality improvement.
- Evaluate and select service providers, securing Quality Agreements for compliance.
Primary Job Requirements:
- Bachelor's degree in life sciences with over 15 years in the biopharmaceutical field.
- Knowledgeable in FDA, EU, and ICH regulations, especially in early-phase trials.
- Experienced in managing GCP inspections; BIMO inspection experience preferred.
- Strong at building cross-functional partnerships to meet strategic goals.
- Proficient in critical thinking, CRO operations, and clinical trial systems.
About Stratacuity:
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
PROVEN SCIENTIFIC PLACEMENT
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