General Scope and Summary
SAGE Therapeutics is searching for a resourceful, integrative thinker for a highly visible role that is responsible for establishing and maintaining standards for GXP compliance at SAGE.
Roles and Responsibilities
- Formulate, establish and maintain policies and procedures and accompanying system related to cGMP, GCP and GLP compliance with global regulatory requirements.
- Establish and maintain an overall Quality System to support Phase 3 and commercial cGMP activities.
- Direct all Quality Operations activities for the disposition of products and product components
- Interact with technical operations teams and leadership to promote continuous improvement programs.
- Direct the management of document control and training systems.
- Establish and maintain systems for vendor qualifications and audits for GXP activities.
- Oversee preparations for and manage preapproval and routine regulatory agency inspections.
- Hire, develop and retain Quality personnel (including contract staff) to create a high-performing team.
- Provide long range planning of Quality System related activities.
- Apprise senior management of critical issues.
- Maintain an in-depth understanding of business principles, industry dynamics, regulatory environment, market trends, and specific operational details related to Quality System activities.
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.
- Bachelor’s degree preferably in a scientific discipline
- 15-20 years experience in quality assurance with demonstrated leadership skills.
- Excellent knowledge of US regulations and ICH guidance related to GXP activities
- Demonstrated success in leading pre-approval inspections by FDA and other regulatory agencies.
- Demonstrate strong analytical and fact-finding abilities.
- Success with anticipation and prevention of long range problems. Strategic effectiveness in long-term problem solving.
- Ability to work collaboratively across departments.
- Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
- 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 and presentation 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