Senior Director, Head of Quality Systems

Location
Working from Home
Posted
Nov 22, 2021
Ref
R001018
Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time

General Scope and Summary

SAGE Therapeutics is searching for a creative, resourceful, integrative thinker to lead the Quality Systems function at Sage Therapeutics.

Roles and Responsibilities

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

  • Develop the strategic roadmap; establish and maintain Quality Systems to support GXP activities.

  • Lead the Document Control, Archiving, and Training functions.

  • Provide day-to-day oversight of Quality Management Systems for Deviation, Change Control, CAPA, and Product Complaint.

  • Enhance and maintain policies and procedures for regulatory compliance.

  • Provide long range planning of Quality System-related activities.

  • Lead Quality initiatives and drive continuous improvement efforts.

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

  • Manage business process owners supporting Quality Systems implementation, testing, and maintenance.

  • Ensure compliant documentation, training, and quality management system processes.

  • Implement and maintain KPIs and Quality metrics.

  • Support the Quality Management Review process.

  • Evaluate Quality and Compliance issues and determine corrective actions and need for escalation.

  • Provide leadership and subject matter expertise during regulatory inspections of Quality Systems.

  • Support submission of INDs and NDAs.

  • Mentor staff and develop the team. Support succession planning activities.

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.

  • 12+ years of experience in the biotech or pharma industries.

  • 10+ years of experience related to Quality Systems activities.

Preferred Qualifications

  • Thorough working knowledge of Quality Systems to support GXP operations and ensure compliance with GXP regulations.

  • Demonstrated ability to apply risk-based approaches to Quality Systems implementation and maintenance.

  • Familiarity with data integrity controls.

  • Understanding and application of domestic and international regulatory requirements.

  • Outstanding communication skills (interpersonal, verbal, and written).

  • Proven track record of industry success including experience supporting regulatory inspections.

  • Strong leadership and management skills.

  • Excellent teamwork and collaboration 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.

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.

Employment Type:Employee

Number of Openings:1

Job ID:R001018

#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.