Sage Therapeutics Job - 45309117 | CareerArc
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Company: Sage Therapeutics
Location: Cambridge, MA
Career Level: Associate
Industries: Healthcare, Pharmaceutical, Biotech

Description

General Scope and Summary 
SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for an important role that is responsible for leading and overseeing the GxP Self Inspection Program. This individual will also contribute to Sage's Vendor Qualification, Regulatory Surveillance, and Risk Management & Inspection Readiness programs. The successful candidate requires a high level of stakeholder engagement, change management experience, and collaboration skills; the successful candidate also requires pragmatic, tangible operational thinking as well as direct experience. This role will require cross-functional collaboration with functional leads across GxP functions at Sage. In this position, the individual will be an integral contributor to Sage's continuous improvement efforts by championing organizational process and system excellence.  

Roles and Responsibilities

  • Partner with Sage functional areas, including Regulatory, Clinical, Technical Operations, Commercial, Pharmacovigilance, and Development sub-teams, as appropriate, to achieve goals and objectives.

  • Direct and lead the Internal Audit program across all GxP functions.

  • Interface with Sage functional areas to provide guidance, interpretation, and educational information on regulations, standards, or other applicable requirements to achieve regulatory compliance.

  • Utilize internal audits as opportunities to expand the Continuous Improvement mindset, promoting functional area transparency, self-identification of improvement opportunities, and sharing of best practices.

  • Develop a risk-based and fit-for-purpose audit schedule that reflects an appropriate level of review across GxP areas and obtain endorsement from key stakeholders as well as Quality management.

  • Ensure audits are robustly planned by identifying appropriate internal or external auditor resources to lead each audit, overseeing the development of individual audit agendas to focus on areas of greatest risk and impact, and scheduling audit activities to deliver on the commitments of the approved audit schedule.

  • Provide for clear communication of risks and improvement opportunities to functional areas in real time.

  • Ensure audit findings are classified and applied consistently across the internal audit program. 

  • Escalate any potential audit findings of concern to Quality management in a timely manner.

  • Ensure audit reports are timely and robust, listing the applicable regulations potentially at issue, providing specific examples where gaps could exist, noting positive examples/best practices observed, and providing suggestions for future improvements.

  • Drive Risk Mitigation and Continuous Improvement initiatives by partnering with functional stakeholders during the audit observation response and ensuing CAPA processes. 

  • Train/qualify new auditors to support program needs, as well as career development objectives of colleagues.

  • Collaborate with Quality Compliance team members on Regulatory Surveillance, Vendor Management, and Risk Management needs as assigned.

  • Review selected Quality Agreements and provide feedback to stakeholders.

  • Participate in the evaluation and selection of contract service providers/vendors for GxP activities, as well as other related service providers, e.g., consultant subject matter experts.

  • Partner on inspection preparation efforts across Sage, working closely with program leads and subject matter experts in GCP, GVP, GLP, GDP, and GMP areas.  

  • Support the hosting and management of regulatory inspections and third-party business partners audits, both onsite and in a virtual setting.

  • Develop and implement internal standards, policies, and procedures in areas of responsibility.

  • Enhance department policies and procedures while ensuring ongoing and continuous compliance with applicable regulations.

  • Implement key performance quality metrics and maintain a state of compliance in assigned programs.


Experience, Education and Specialized Knowledge and Skills

Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient. Must have excellent interpersonal skills, the ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, and the ability to identify issues and raise to key stakeholders in order to develop relevant and realistic plans, programs, and recommendations. Must have a demonstrated ability to translate strategy into action, excellent analytical skills, and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.


Basic Qualifications

  • Bachelor's degree required.

  • 6+ years of experience in the pharmaceutical or biopharmaceutical industry.

  • 5+ years of experience in a Quality Compliance related role.


Preferred Qualifications

  • Ability to travel to support audits and inspection activities (up to 15%).

  • 10+ years of related GxP experience in the pharma or biotech industries.

  • Extensive experience conducting internal or vendor audits across GxP areas.

  • Certification as a Qualified Auditor by an established industry organization is a plus.

  • Strong working knowledge of GxP regulations and industry best practices.

  • Experience across GCP, GLP, and/or GVP operations strongly preferred.

  • Excellent written and verbal communication skills, presentation skills, and relationship-building capabilities.

  • A proven ability to influence decision-making without authority.

  • Demonstrated excellence in cross functional collaboration to drive and implement organizational change. 

  • Experience with all phases of the Product Lifecycle (early-stage pre-clinical development through commercial and post-marketing drug safety).

  • Familiarity with ALCOA+ Data Integrity governance requirements across a variety of system platforms.

  • Ability to analyze complex issues and thoroughly assess risk. 

  • Working knowledge of Veeva Vault, Asana, PowerPoint, Excel, Redica, and Infodesk platforms.

  • Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.

  • Demonstrated continuous improvement experience (Six Sigma belt certification preferred).

  • Strong team player that has a customer service approach and is solution-oriented.

  • Demonstrated technical agility and leadership skills, including a passion for working within multiple teams and proven ability to achieve results in a matrix organization.

  • Embrace our Core Values: Put People First, Improve Lives, Cultivate Curiosity, Do Right, and Forge New Pathways.

  • Excitement about the vision and mission of Sage.

Employment Type: Employee Number of Openings: 1 Job ID: R001512 #Biotechnology #Careers #ThisIsSage

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.

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.

EEO is the Law

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Pay Transparency Nondiscrimination

We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Sage Therapeutics, Inc.

#LI-Remote


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