Sage Therapeutics Manager, Quality Assurance - GCP in Cambridge, Massachusetts
SAGE Therapeutics is searching for a creative, resourceful, integrative thinker to contribute to Quality activities in support of research projects across multiple therapeutic areas with a focus on GVP and GCP compliance and audit activities.
Roles and Responsibilities
Assess GVP and GCP compliance risk areas (internal and external) and develop and implement risk mitigation measures.
Plan and lead GVP and GCP audits (international and domestic), including clinical investigator site, contract clinical laboratories, CROs, and marketing partners to determine compliance status and identify compliance risks.
Participate in cross functional Clinical Study Team meetings and provide guidance as needed.
Provide guidance, interpretation and information on regulations, standards and quality systems to Sage functional areas.
Supporting inspection readiness activities for development compounds.
Ensure compliance with company's procedures and regulatory requirements.
Participate in the evaluation and selection of CROs and other clinical, pharmacovigilance service providers.
Develop and implement standards, policies and procedures for regulatory compliance.
Experience, Education and Specialized Knowledge and Skills
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, and program recommendations. Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
- B.S. Degree with 6+ years of GCP experience in the pharmaceutical or biopharmaceutical industry.
Demonstrated experience in supporting QA decisions in GVP, GCP, and/or GLP.
Strong analytic skills and track record of 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).
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.
Number of Openings:
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All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.
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