Sage Therapeutics Senior Director, Quality Operations in Cambridge, Massachusetts
General Scope and Summary
SAGE Therapeutics is searching for a resourceful, integrative thinker for an importantrole 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
# of Openings 1