General Scope and Summary
SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for an important role that is responsible for management of and continuous improvement of the SAGE Quality Systems.
Roles and Responsibilities
QUALITY SYSTEMS & COMPLIANCE
- Supports, facilitates and adapts the Quality Management System to ensure that it meets US and Ex-US regulatory and industry standards and expectations.
- Key Contributor for continued implementation and roll-out of Quality Manual / Quality System.
- Provides expert guidance on Quality Systems including writing/routing/approving SOP’s, advising on changes to Quality Manual that impact the specific Quality System.
- Strong lead in developing controlled documents (e.g., SOPs, Policies, Specifications, Methods, etc.) as needed to ensure defined quality objectives are met.
- Manages deviations, CAPAs, complaints, and change controls per the SAGE Quality Management System.
- Ensures that all required aspects of the Quality Management System are trended on a routine basis for presentation to senior management for review.
- Manages the internal audit programs.
- Provides key support for Inspection Readiness programs.
- Coordinates with operating entities to ensure that audits of quality systems are conducted on a continuing basis, to enforce requirements and meet specifications.
- Supports QA Documentation & Training Plans/GxP Training Modules with Quality and internal/external stakeholders
- Lead, manage and organize Quarterly Quality Council, define key metrics for monthly/quarterly meetings for commercial/clinical products, deviations, complaint management, change control and key Quality Systems reports.
- Lead/Manage with defined action plans Deviation Meetings and Change Control Boards.
- Key Support and organization for Inspection Readiness Programs and project sub-teams to provide overall quality direction for product development.
- Involvement in process, compliance, and quality system improvement efforts.
- Support submission of INDs and NDAs for key projects.
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, 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.
- B.S/B.A. in an engineering, operations or science degree.
- 10+ Quality Assurance experience including 5 years’ experience in Quality Assurance Managerial roles
- Possess in-depth knowledge of GCP/GLP/GMP regulations, principles, concepts, industry practices and standards
- Ability to evaluate Quality Systems and drive value added enhancements
- Strong interpersonal and collaboration skills; must be able to positively influence employees who are working with the normal chain of command in order to achieve results.
- Ability to author and critically review SOPs
- Experience in validation / computerized system validation / Part 11 / Data Integrity
- Excellent knowledge in MS Office, Visio, MS Project, eLMS, EDMS systems and database software
- Excellent interpersonal, problem solving, risk analysis and negotiation skills.
- Effective organization, communication, and team orientation skills.
- Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
- Ability to coordinate timelines with internal customers and external clients and vendors.
- Strong team player that has a customer service approach and is solution oriented.
- Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
- Possesses strong written and verbal communication 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