Sage Therapeutics Senior Director, Quality Operations in Cambridge, Massachusetts

Overview

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

ID 2017-1936

# of Openings 1

Category Quality/Regulatory