General Scope and Summary:
SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for an important role that is responsible for managing systems related to GxP compliance.
Roles and Responsibilities:
- Plan, support, and manage Product Complaints as well as other Quality Systems (e.g. Deviations, Investigations, CAPAs, Change Controls, Internal Audits).
- Assess compliance risk areas (internal and external) and develop and implement risk mitigation measures.
- Assist and provide guidance for regulatory inspection readiness activities.
- Ensure compliance with company's procedures and regulatory requirements.
- Conduct QA reviews of Deviations, Investigations, CAPAs, Change Controls, Internal Audits, and Product Complaints.
- Facilitate training of functional areas and develop appropriate training for personnel involved in the execution of Quality System processes.
- Facilitate and participate in audits of GxP contract service providers.
- Provide guidance, interpretation and information on GxP regulations, standards and quality systems to Sage functional areas
- Develop and implement standards, policies and procedures for GxP regulatory compliance.
- Develop and measure quality metrics to drive consistent quality standards relating to Quality System activities. 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:
- Bachelor’s degree with 5+ years’ experience in Biotech or Pharma and 5+ years’ experience in Quality Systems.
- Strong analytic skills with practical knowledge of how to identify key performance quality metrics to set targets for maintaining a state of compliance while identifying areas for improvement.
- Extensive experience in managing.
- Understanding and application of domestic and international regulatory requirements.
- Outstanding communication skills (interpersonal, verbal and written).
- Proven track record of industry success.
- Strong leadership and management skills; 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 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.