Sage Therapeutics Senior Manager, Research Quality - Nonclinical in United States
General Scope and Summary
SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for an important role that is responsible for Quality activities supporting research projects across multiple therapeutic areas, with a focus on GLP compliance and inspection readiness.
In this position, you will be an integral contributor to Sage’s GLP quality and continuous improvement efforts. This role will require inter-departmental collaboration with program leads who support GLP functions at Sage. The successful candidate is highly collaborative with significant experience in stakeholder engagement and continuous improvement. Pragmatic, tangible, operational thinking and direct GLP experience are required.
Roles and Responsibilities
Assess GLP compliance risk areas (internal and external); develop and implement risk mitigation strategies.
Represent Research Quality as a single point of contact and provide guidance for assigned nonclinical programs.
Serve as a member of cross-functional study teams with participation in the applicable forums, providing GLP compliance advice and guidance to achieve continuous quality improvement and effective quality assurance.
Develop and implement internal standards, policies, and procedures to ensure regulatory compliance.
Develop and measure prospective and retrospective key performance and quality indicators to drive consistent quality standards relating to bioanalytical and GLP activities.
Ensure compliance with the company's procedures and regulatory requirements.
Participate in the evaluation and selection of contract service providers (CSPs) for bioanalytical and GLP activities, as well as other service providers, e.g., audit consultants.
Contribute to the planning and oversight of bioanalytical test site and nonclinical testing facility audits to determine compliance status and identify compliance risks. Upon audit completion, communicate results to the relevant stakeholders and interact with various teams to ensure corrective and preventative actions (CAPA) are taken to close observations as applicable.
Support quality event management for assigned nonclinical programs, including assessment of potential root causes and CAPA.
Maintain relevant knowledge of both local and international bioanalytical and GLP guidance and regulatory requirements that impact Sage standards.
Experience, Education and Specialized Knowledge and Skills
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient. Must have excellent interpersonal skills, the ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, and the ability to identify and raise issues to key stakeholders to develop relevant and realistic plans, programs, and recommendations. A demonstrated ability to translate strategy into action, analytical skills, the ability to communicate complex issues in a simple way, and the ability to orchestrate plans to resolve issues and mitigate risks are required.
5+ years of experience in the biotechnology or pharmaceutical industry with Research Quality (GLP) responsibilities.
Ability to travel to support audits activities (up to 15%).
4+ years of experience supporting bioanalytical and GLP activities.
Strong working knowledge of domestic and international GLP regulations and ICH guidance.
Understanding of the application of domestic and international GLP regulatory requirements.
Experience auditing testing facilities and test site CSPs.
Outstanding communication skills (interpersonal, verbal, and written).
Excellent teamwork and collaboration skills.
Strong management and leadership skills.
Strong analytic skills with practical knowledge of how to identify quality metrics and set targets for maintaining a state of compliance while identifying areas for improvement.
Strong team player that has a customer service approach and is solution-oriented.
Embrace our core values: Put People First, Improve Lives, Cultivate Curiosity, Do Right, and Forge New Pathways.
Excitement about the vision and mission of Sage.
Benefits and Compensation
The base salary hiring range for this position is $125,606 - $172,709.*
The actual salary offered within the range is dependent on a variety of factors including, but not limited to, relevant experience, qualifications, education, skills, and performance.
This position is eligible to participate in the Company’s annual bonus plan; the bonus varies based on performance and is subject to the standard terms and conditions of the incentive program.
To support your well-being, we offer a comprehensive benefits and wellness package, which includes medical, dental, and vision coverage upon hire. More information can be found in our Benefits Guide (https://careers.sagerx.com/media/ngth5cdv/sage-us-benefits-guide.pdf) .
*Base salary ranges are periodically reviewed and subject to change.
Protected personal characteristics include: age, race, ancestry, color, sex, national origin, sexual orientation, gender identity or expression, religious creed, mental or physical disability, pregnancy, genetic information, marital or civil union status, participation in the uniformed services of the United States, or any other characteristic protected under applicable federal, state or local law. To learn more, see Sage's Anti-Harassment and Equal Opportunity Policy