Sage Therapeutics

  • Senior Director, Quality Operations

    Job Locations US-MA-Cambridge
    Posted Date 7 months ago(10/25/2017 4:37 PM)
    ID
    2017-1936
    # of Openings
    1
    Category
    Quality/Regulatory
  • Overview

    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

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