General Scope and Summary
SAGE Therapeutics is searching for a resourceful, integrative thinker for an important role that is responsible for Quality Assurance operations oversight and support of clinical development projects within CMC project teams. This role will have significant interface with both internal CMC teams as well as a network of external vendors.
Roles and Responsibilities
- Oversight of the activities associated with manufacturing and disposition of clinical materials.
- Represent Quality Operations on CMC project teams.
- Management of lot disposition activities to ensure that materials are released in accordance with regulatory requirements, cGMPs and policies and procedures and within project lead times.
- Primary Quality contact for external vendors.
- Interface with internal departments and external vendors on a variety of technical/quality subjects.
- Contribute to the evaluation and mitigation of program risks and escalation of potential significant quality issues.
- Review and approve documents necessary to support the program and disposition activities originating from internal departments and vendors.
- Participate in developing project plans and/or corrective action that may impact multiple functions.
- Perform work under limited direction and guidance, with general instruction on new assignments.
- Monitor and review the performance of vendors.
- 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, programs and 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.
Experience, Education and Specialized Knowledge and Skills
- B.A. or B.S. degree (preferably in Chemistry)
- At least five to seven years of experience in the pharmaceutical or biopharmaceutical industry or an equivalent combination of education and experience.
- Sound knowledge of cGxPs (GMP primarily) and international regulations.
- Experience with all phases of the Product Lifecycle (Development and Tech Transfer a plus)
- A combination of Quality and technical experience (development, manufacturing, analytical, validation)
- Experience building internal and external relationships and working with external vendors.
- Ability to make sound decisions about managing priorities and ability to acutely assess inter and intra-organizational impact of decisions.
- Ability to work with CMC teams.
- Flexibility in problem solving and providing direction to meet business objectives.
- Ability to travel to meet program needs (est. 10-15%).
- 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