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Associate Director, Quality Compliance - Auditing, GCP

  • Quality
  • US - Remote
  • Worker Status: Employee
  • Time Type: Full time

Description

General Scope and Summary 

SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for an important role that is responsible for leading the GxP Internal Audit & Self Inspection program. This role will also contribute to Sage’s Vendor Qualification, Regulatory Surveillance, Risk Management & Inspection Readiness programs. In this position you will cross-functionally collaborate with functional leads across Sage, and be an integral contributor to Sage’s continuous improvement efforts by championing organizational process improvement and system excellence. 

Roles and Responsibilities (Essential Functions)

  • Partner with Sage functional areas, including Regulatory, Clinical, Data Science, 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, including Clinical R&D, Manufacturing, Distribution, Pharmacovigilance and Preclinical development, as well as Information Technology.

  • Interface with key stakeholders 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 plan that reflects an appropriate level of review across GxP areas and obtain endorsement from functional area leadership as well as Quality management.

  • Provide clear communication of risks and improvement opportunities to functional areas.

  • 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.

  • 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 / in-person and in a virtual setting.

  • Develop and enhance department standards, policies and procedures, while ensuring continuous alignment 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.

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

Preferred Qualifications

  • 10+ years of related GxP experience in the Pharma or Biotech industries.

  • Experience partnering with GCP related functions strongly preferred; including Clinical Operations, Data Management, Investigational Review Boards, Biostatistics, Medical Writing and related functions who contribute to the Clinical Trial lifecycle.

  • Proven track record of experience supporting regulatory inspections with favorable outcomes, including BIMO (GLP, IRB, PADE, REMS, etc.), and/or Drug Compliance (i.e. PAI, Drug Manufacturing, Sterile Processing).

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

  • Extensive experience conducting internal or vendor audits across GxP areas, with a demonstrated ability to analyze complex issues and thoroughly assess compliance risk.

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

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

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

  • Robust technical agility and leadership skills, with a proven ability to effect decision-making without authority.

  • Experience with all phases of the Investigational Product Lifecycle (early-stage pre-clinical development through pivotal clinical trials), as well as a foundational knowledge base of commercial & post-marketing drug safety regulatory requirements.

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

  • 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, with demonstrated ability to influence for greater outcomes in a matrix organization.

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

  • 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.

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 $146,270 - $201,122.*

  • 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.
*Base salary ranges are periodically reviewed and subject to change.

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.

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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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.

Employment applications

Employment applications are processed through a website that is not owned or controlled by Sage Therapeutics, Inc. Sage Therapeutics, Inc. makes no representation as to the accuracy of the information contained on websites it does not own or control. Sage Therapeutics, Inc. does not recommend and does not endorse the content of any third-party websites. Your use of third-party websites is at your own risk and subject to the terms and conditions of use for such sites.

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