MassBio Career Center

Director, DSPV Inspection Readiness & Compliance

Sage Therapeutics
Boston, Massachusetts, United States
24 days ago

Description

Location: EMAIL: Workday@Sagerx.com, Massachusetts, United States of America, 02142
Type: Full time

General Scope and Summary

Sage Therapeutics Drug Safety & Pharmacovigilance is searching for an experienced Director of Inspection Readiness and Compliance that is creative, resourceful, and an integrative thinker. The Director will assist with the maintenance of the Global Quality System for DSPV that supports Sage products in compliance with FDA and ICH Guidelines and international regulatory requirements.

The successful candidate will have a proactive and innovative approach and a flexible, hands-on nature that works with a high sense of urgency. Primary responsibilities include oversight of the DSPV inspection readiness program and DSPV compliance activities, including the safety vendor. Additional responsibilities include support for new or revised pharmacovigilance agreements and all Sage contracts requiring PV language.

Effective communication skills will be key, as this role provides an excellent opportunity for close collaboration with colleagues from other functions such as Clinical Operations, Medical Science, Data Science, Regulatory Affairs, Quality Systems, Medical Affairs, and Legal.

Roles and Responsibilities

Management - 10%
  • Direct line management for the Senior Manager of Quality, Compliance & Training.
  • Establish and define annual goals for direct report(s) that are aligned with Sage corporate goals. Ensure direct report goals include professional growth and development.
  • Actively provide ongoing evaluation of goals throughout the year utilizing the Sage Checkpoint process.
  • Maintain and enhance the current onboarding curriculum for Quality, Compliance, and Training staff.
  • Actively participate in the interview process and onboarding of all new DSPV members, as applicable.
  • Represent DSPV as a leader on cross-functional teams and committees.


Inspection Readiness - 40%
  • Lead the DSPV inspection readiness initiative and collaborate with Sage Quality Systems to ensure alignment across the organization.
  • Maintain and update the DSPV inspection readiness "playbook" to reflect regulation and processes changes that ensure DSPV is in a state of inspection readiness.
  • Perform routine gap analysis of DSPV processes and prepare a strategy for correcting findings.
  • Actively assist with audit responses from health authorities and external partners/vendors.
  • Evaluate proposed corrections, corrective actions, and/or preventative actions for compliance with applicable regulations, guidelines, and Sage policies.
  • Prepare a monthly status report for DSPV management regarding inspection readiness and escalate any significant findings or gaps that require immediate attention.
  • Participate in DSPV audits and Health Authority Inspections as a subject matter expert.
  • Prepare other DSPV Subject Matter Experts (SME) for participation in internal audits, health authority inspections with prep sessions, storyboard development, and knowledge transfer documentation.
  • Utilize the DSPV Quality Consultant for support as needed.


PV Alliance & Sage Contracts - 15%
  • Maintain a Sage Pharmacovigilance Agreement template (PVA) that is aligned with the business needs and includes the required legal components.
  • Directly collaborate with Sage Legal in the preparation or revision of PVAs.
  • Work with Sage PV partners to develop, finalize, and revise PVAs as needed.
  • Collaborate with Sage business owners and Legal to ensure contracts with external parties contain the appropriate safety language to ensure complete and timely reporting of safety information to DSPV.
  • Maintain the PV language templates used for third party contracts.
  • Develop and maintain Adverse Event training decks and provide AE training to Sage business owners upon request.
  • Monitor and maintain the DSPV Agreement Tracking Tool.


Compliance - 20%
  • Ensure monthly KPIs and metrics are compiled and sent to DSPV Leadership for review.
  • Monitor KPIs and metrics for compliance trends and propose appropriate corrective actions.
  • Escalate any potential compliance risk for the department or the company at large to the Head of DSPV.
  • Participate in regular touch base sessions with Research Quality Assurance (RQA).
  • Serve as the point of contact for the DSPV safety vendor regarding quality and compliance issues.
  • Responsible for the oversight of DSPV safety vendor deviations to ensure deviation are well documented and reflect accurate root cause and appropriate corrective actions.
  • Manage internal deviations and collaborates with RQA representative to mitigate the risk.
  • Responsible for the maintenance of the safety vendor Quality Management Plan.
  • Maintain a risk tracker for DSPV with DSPV and communicates the topics to RQA.


Standards & Training - 15%
  • Develop and maintain policies and procedures for the DSPV Quality System and provide DSPV Quality Assurance support for SOPs, auditing, deviations, training, and CAPAs.
  • Responsible for maintenance of the DSPV training curriculum that expands to applicable cross-functions.
  • Identify relevant quality-related training needs and conduct training as required.
  • Monitor adherence and compliance with department documented procedures.
  • Monitor monthly department SOP training compliance.
  • Monitor monthly safety vendor training compliance.


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 analyze complex issues 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 in life sciences, pharmacy, nursing, or equivalent health experience; advanced life sciences degree or MBA preferred.
  • Minimum of 8 years of experience in Pharmacovigilance with specific role with Inspection Readiness.


Preferred Qualifications
  • 10-12 years of experience in Pharmacovigilance with specific role with Inspection Readiness.
  • Previous experience with writing or drafting Pharmacovigilance Agreements.
  • Previous managerial experience.
  • Demonstrated ability to create, evaluate, and maintain effective business processes and implement procedures, systems, and tools to maximize resources within a Drug Safety department.
  • Thorough knowledge and experience with quality systems.
  • Prior pharmaceutical or biotechnology drug development experience.
  • Comprehensive knowledge of the US FDA regulations and the international pharmacovigilance regulations and requirements, including European Medicines Agency (EMA) Good Pharmacovigilance Practices (GPV).
  • Excellent oral and written communication skills.
  • Strong interpersonal and leadership skills and demonstrated ability to manage, motivate, and influence work behaviors of individuals who are not direct reports.
  • Desire to embrace the Sage Core Values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
  • Demonstrates excitement about the culture, vision, and mission of Sage.


Employment Type:

Employee

Number of Openings:

1

Job ID:

R000926

#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.

EEO is the Law

EEO is the Law - Poster Supplement

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 obligationand, 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.

Apply Here

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Job Information

  • Job ID: 58891186
  • Location:
    Boston, Massachusetts, United States
  • Position Title: Director, DSPV Inspection Readiness & Compliance
  • Company Name: Sage Therapeutics
  • Job Function: Research
  • Job Type: Full-Time
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