General Scope and Summary
SAGE Therapeutics is searching for a resourceful, integrative thinker for an important role that is responsible for oversight of GMP Quality Operations.
Roles and Responsibilities
- Oversee staff supporting clinical trial and commercial Quality Operations activities
- Assure appropriate resources for batch record review
- Determine dispositions of drug substance, drug substance intermediates, (steriles/solids) drug product and packaged/labeled products according to established standards for clinical trial and commercial material.
- Write/review/approve written standards, including Master Production Records, Standard Operating Procedures, Specifications, Test Methods, and Change Control Documentation.
- Conduct Quality / Technical review of product quality-related issues pertaining to test methods and results, equipment, cleaning, sterility, process controls, validation activities, etc.
- Provide oversight of Stability Program management via oversight of activities conducted by Analytical and Technical Operations departments
- Manage product technical investigations (deviations, out of trend, out of specification) associated with manufactured lots
- Establish strong interfaces with contract manufacturers to address and resolve complex and routine activities while building client relationship and continuous improvement
- Provide in-depth technical advice to project teams regarding Phase I-IV manufacturing, analytical and process development
- Work closely with Quality Systems group to support inspection readiness both internally and at key contract manufacturing organizations.
- Present key issues related to product quality to Quality Management
- Support submission of INDs and NDAs.
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 and ability to develop relationships with key stakeholders. Ability to communicate issues in a simple way and to orchestrate plans to resolve issues and risks.
- B.S/B.A. in an engineering, operations or science degree a must.
- 15+ Quality Assurance experience including 7 years’ experience in Quality Assurance director and leadership roles
- Possess in-depth knowledge of GMP regulations, principles, concepts, industry practices and standards
- Strong knowledge of GMP quality assurance processes and procedures including parenteral and solid dosage manufacturing
- Strong knowledge of GMP quality control methods
- In-depth experience in validation of commercial processes and methods
- Ability to evaluate quality procedures and processes 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
- Excellent interpersonal, problem solving, risk analysis and negotiation skills.
- Effective organization, communication, and team orientation skills.
- 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