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Manager, Quality

Employer
Sage Therapeutics
Location
Working from Home
Start date
Sep 25, 2022

View more

Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time

Job Details

General Scope and Summary 

Sage Therapeutics is searching for a creative, resourceful, integrative thinker for a role as a Manager, Quality. The successful candidate will work as part of the Quality team to lead Quality Risk Management activities and manage Quality Inspection Readiness efforts.

Roles and Responsibilities

  • Lead Quality Risk Management activities and facilitate risk assessments. 

  • Work closely with department heads to identify and mitigate risk for the organization. 

  • Manage the Quality Risk Register.

  • Partner with functional areas to assess quality of outsourced activities, implement risk control plans, and determine CAPAs.

  • Lead and coordinate GMP Inspection Readiness efforts at Contract Service Providers (CSPs) and Sage. 

  • Interface with regulatory agencies as required in support of regulatory agency inspections.

  • Visit the CSPs to provide support for and oversight of Inspection readiness activities and GMP compliance.

  • Support the collection, preparation, and management of Quality metrics in support of Quality Inspection Readiness.

  • Define Quality objectives, implement and monitor performance indicators to measure process against quality objectives, and drive organizational change.

  • Enhance policies and procedures and ensure compliance with applicable regulations.

  • Support day-to-day activities of Product Complaints.

  • Drive on-time closure of Complaint Records.

  • Support Data Integrity (DI) activities at Sage.

  • Contribute to and execute on continuous improvement plans. 

  • Keep abreast of the requirements for compliance and notify management of regulatory compliance concerns.  

  • Perform other duties and assignments as required and defined by management. 

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.

  • 4+ years of experience in biotech or pharma; 3+ years of experience in Quality.

Preferred Qualifications

  • 3+ years of experience conducting review and approval of Quality investigations.

  • Experience conducting Quality Risk Management activities.

  • Strong working knowledge of GxP regulations and ICH Q7 guidelines with the ability to assess compliance risks.

  • Experience with supporting regulatory inspections.

  • Knowledge in partnering with Contract Manufacturers and Contract Testing Laboratories.

  • Familiar with QC and Stability testing requirements.

  • Working knowledge of electronic Quality Management Systems (experience with Veeva eQMS is a plus) and requirements for maintaining GXP computer systems in a validated state.

  • Experience authoring, revising, and reviewing Quality policies, procedures, and/or Work Instructions.

  • Strong analytical problem-solving skills.

  • Strong team player with a customer service focus and solution-oriented approach.

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

  • Ability to work individually and within a multi-disciplinary team with individuals at all levels of the organization.

  • Excitement about the vision and mission of Sage.

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

Employment Type:Employee

Number of Openings:1

Job ID:R001447

#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 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.

Company

Welcome To The Workplace With A Difference

Our vision is to fearlessly lead the way to create a world with better brain health – a vision we can only achieve with the help of our amazing team of highly knowledgeable, deeply passionate individuals.

At Sage, we believe that life is more than just a destination. We’re concerned with the journey, and we care deeply about everyone contributing to and benefiting from our own company journey. This means helping people discover the right path for them and carefully guiding colleagues along the way.

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Stock Symbol:

SAGE

Company info
Website
Phone
617-299-8380
Location
215 First Street
Cambridge
MA
02142
United States

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