General Scope and Summary
SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for an important role that is responsible for GCP and GLP compliance and audit activities.
Roles and Responsibilities
- Plan and lead GCP and GLP audits (international and domestic), including clinical investigator site, contract clinical laboratories, and CROs to determine compliance status and identify compliance risks.
- Assess GCP and GLP compliance risk areas (internal and external) and develop and implement risk mitigation measures.
- Assist and provide guidance for regulatory inspection readiness activities.
- Ensure compliance with company's procedures and regulatory requirements.
- Conduct QA reviews of project-related Clinical Development essential documents (e.g. protocols, amendments, case report forms, tables and listings, informed consents, investigator brochures, and Clinical Study Reports).
- Review and provide input into non-clinical documentation (e.g. protocols, study reports).
- Facilitate GCP/GLP training of functional areas and develop appropriate training for personnel involved in the execution of clinical trials and nonclinical studies.
- Participate in the evaluation and selection of CROs and other clinical and nonclinical service providers.
- Provide guidance, interpretation and information on GCP and GLP regulations, standards and quality systems to Sage functional areas
- Develop and implement standards, policies and procedures for GCP/GLP regulatory compliance.
- Develop and measure quality metrics to drive consistent quality standards relating to GCP and GLP activities.
Experience, Education and Specialized Knowledge and Skills
- Bachelor’s degree with minimal 10 years’ experience in Biotech or Pharma and 5+ years’ experience in Quality Systems related to GCP and GLP.
- Strong analytic skills with practical knowledge of how to identify key performance quality metrics to set targets for maintaining a state of compliance while identifying areas for improvement.
- Extensive experience auditing clinical CRO’s, clinical sites and investigator sites.
- Understanding and application of domestic and international regulatory requirements.
- Outstanding communication skills (interpersonal, verbal and written).
- Proven track record of industry success.
- Strong leadership and management skills.
- Excellent teamwork and collaboration skills.
- Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
- Excitement about the vision and mission of Sage.