Senior Manager, Quality Job Listing at Sage Therapeutics in Cambridge, MA (Job ID SAGEUSR001549EXTERNALENUS)

Description

General Scope and Summary

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

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.

• Coordinate GMP Inspection Readiness efforts with Contract Service Providers (CSPs).

• 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.

• 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 activities at Sage Therapeutics and CSPs.

• Contribute to and execute on continuous improvement plans.

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

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.

• 5+ years of experience in the biotech or pharmaceutical industry with QA responsibilities.

Preferred Qualifications

• 7+ years of experience in Quality Assurance.

• 4+ years of previous experience in conducting review and approval of Quality investigations and Product Complaints records.

• Extensive experience conducting Quality Risk Management activities, including implementation of risk mitigation plans.

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

• Experience partnering with Contract Manufacturers and Contract Testing Laboratories.

• Familiar with QC and Stability testing requirements.

• Experience with supporting regulatory inspections and audits.

• Working knowledge of electronic Quality Management Systems (experience with Veeva eQMS is a plus).

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

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

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

• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.

• Possesses strong written and verbal communication skills.

• 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.

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.

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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.