Director, Quality Control – Head of Quality Control

Description

General Scope and Summary

SAGE Therapeutics is searching for a creative, resourceful, and integrative analytical thinker for a highly visible role to lead the Quality Control (QC) function supporting successful characterization, scale up, manufacturing, and testing of novel CNS medications. As a key member of the Analytical Development and Quality Control team, the successful candidate will work closely with other functions including Quality Operations, Process Development, Formulation Development, and Regulatory Affairs to support late-stage development and commercial programs.

Roles and Responsibilities

• Set strategic direction for the Quality Control function and contribute to the strategic direction for the Quality organization.

• Manage quality control related activities for late-stage programs in order to advance Sage’s fast-growing portfolio of products.

• Lead Quality Control initiatives and drive continues improvement efforts. Oversee analytical activities conducted at Contract Service Providers (CSPs) including stability studies, release testing of drug substance, drug products, investigations, deviations, and reference standards.

• Manage quality control testing execution at multiple CSPs, ensuring contract sites deliver high quality analytical services for successful lot disposition and stability monitoring.

• Actively communicate and collaborate with colleagues and third-party vendors to ensure optimal execution, data recording, and reporting of analytical activities that are performed according to agreed-upon timelines in support of business objectives.

• Enhance data integrity controls and partner closely with Quality Assurance to implement data governance.

• Provide QC representation during project team meetings; oversee quality control requirements for compliance with cGMP/CFR/ICH regulations and guidelines. 

• Actively participate in the design of specifications in alignment with control strategies in a changing developmental environment for drug substances and drug products.

• Author/review/approve deviations, investigations, OOS/OOT, CAPAs, data interpretation, data presentation, statistical analysis, and trending.

• Author, review, and provide input for appropriate sections in regulatory filings including NDAs.

• Collaborate closely with other functions including Quality Assurance, Process and Formulation Development, and Regulatory Affairs to ensure programs are effectively supported and high-quality standards maintained.

• Enhance and maintain policies and procedures for regulatory compliance.

• Partner with functional areas to assess GXP compliance risks and develop and implement risk mitigation measures and the need for escalation.

• Implement and maintain QC metrics and support Quality Management Review process.

• Provide leadership and subject matter expertise for the Quality Control function during regulatory inspections.

• Mentor staff and develop the team.

Experience, Education and Specialized Knowledge and Skills

The successful candidate has a broad understanding of QC, analytical sciences, and regulatory/GMP requirements, as well as a proven track record in QC department for commercial programs. Must thrive in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient. Excellent communication and collaboration skills in a cross-functional and fast-paced environment as well as a proven ability to achieve results in a virtual setting with external laboratories and manufacturing facilities are a must.

Basic Qualifications

• Bachelor’s degree.

• 8+ years of experience related to Quality Control in the biotech or pharmaceutical industry.

Preferred Qualifications

• Advanced degree in chemistry, chemical engineering, or related field; PhD preferred.

• 10+ years of relevant small molecule analytical experience.

• Requires a strong background in QC and expertise in various separation and characterization techniques, as well as a thorough knowledge of cGMP, ICH, and relevant FDA guidelines.

• Demonstrated proficiency in hands-on analytical work with a broad range of analytical techniques; charged aerosol detection and mass spectrometry experience is a plus.

• Proven track record in managing analytical and quality control aspects of development programs in advanced clinical stages.

• Extensive experience in reviewing, organizing, and presenting analytical data.

• Strong problem-solving skills and ability to solve complex analytical challenges at CSPs.

• Extensive data integrity and data governance experience.

• Excellent organizational and documentation skills.

• Experience managing and developing people and teams.

• Excellent verbal and written communication skills; ability to drive decisions.

• Thorough working knowledge of GMPs, ICH, and FDA guidelines.

• Experience in authoring regulatory documents and submissions. Experience in NDA and/or MAA writing is a plus.

• Ability to multitask and succeed in a fast moving and dynamic environment.

• Ability to travel up to 15% of time.

• Embraces our core values: Put People First, Improve Lives, Cultivate Curiosity, Do Right, and Forge New Pathways.

• Excitement about the vision and mission of Sage.

This job description may not be inclusive of all assigned duties, responsibilities, or aspects of the job described. Other duties may be added, or this description amended at any time at the sole discretion of Sage.

Benefits and Compensation

The base salary hiring range for this position is $156,817 - $215,623.*

• The actual salary offered within the range is dependent on a variety of factors including, but not limited to, relevant experience, qualifications, education, skills, and performance.
• This position is eligible to participate in the Company’s annual bonus plan; the bonus varies based on performance and is subject to the standard terms and conditions of the incentive program.
• To support your well-being, we offer a comprehensive benefits and wellness package, which includes medical, dental, and vision coverage upon hire. More information can be found in our Benefits Guide.

Job ID: R001916

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All Sage new hires will be required to provide documentation that they are fully vaccinated against COVID-19 or, if not, that they are legally entitled to an accommodation due to a medical condition or a sincerely held religious belief.  Requests for accommodation will be considered on a case-by-case basis, and Sage will consider, among other things, whether the proposed accommodation would create an undue hardship.

All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

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Equal Opportunity Employer. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

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