Quality Compliance Manager Consultant, Vendor Management
- Employer
- Sage Therapeutics
- Location
- Working from Home
- Start date
- Jul 6, 2022
View more
- Discipline
- Quality, Quality Control, Regulatory, Legal/Compliance
- Required Education
- Bachelors Degree
- Position Type
- Full time
Job Details
General Scope and Summary
Sage Therapeutics is searching for a resourceful, integrative thinker for an important and highly visible role that is responsible for Vendor Management oversight. In this position, you will be an integral contributor to the external auditing program for GxP vendors, interfacing with both internal and external stakeholders.
Roles and Responsibilities
Manage and support aspects of the GxP (GLP, GCP, GMP, GPV) Vendor Management Program by scheduling external audits, following up on audit responses, and tracking audit actions to closure; priority will be given to individuals who have direct experience in GCP/GLP/GVP.
Manage and maintain vendor files in paper and electronic form.
Track CAPAs associated with key vendors in accordance with applicable regulations, guidelines, and Sage SOPs.
Support consultant auditors to ensure that audits, audit reports, and other work produced are of acceptable quality and in compliance with Sage requirements, including consultant auditor contracts and training.
Review at a technical level and approve audit agendas, reports, and responses.
Monitor and ensure audit deliverables (report, responses, and corrective actions) adhere to internal timelines according in Sage procedures related to CROs, CMOs, and suppliers.
Provide status updates to Sage stakeholders on audit progress.
Collaborate with Research Quality Assurance and support correction of performance/compliance issues identified from a holistic view of vendors.
Elevate problems to Quality management for immediate and long-term resolution across Sage.
Provide support to Sage Quality Management Review by trending aspects of the Quality Management Program on a routine basis for presentation to senior management for review.
Support the build of continuous improvement for Quality Compliance to ensure regulatory and industry standards are met.
May support internal audits.
Support additional Quality Compliance functions as determined by management that may include regulatory surveillance and inspection readiness.
Possess excellent communication skills and represent the Quality group in a positive manner.
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 management 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 related experience in the biotech or pharmaceutical industry.
Experience building relationships in working with external vendors and internal stakeholders.
Experience with external audit process and possess the ability the translate audit findings into corrective actions plans that mitigate risks to the company and to patient safety and data integrity in the following areas: external CROs, laboratories (clinical and non-clinical), and/or CMOs.
Must have technical knowledge of GCP, GLP, GVP or any combination thereof.
Preferred Qualifications
6+ years of related experience in the biotech or pharmaceutical industry.
Experienced in SharePoint and other Microsoft applications (Word, Excel, PowerPoint).
Knowledge of quality activities at all phases of the product lifecycle.
Outstanding communication skills.
Excellent teamwork and collaboration 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.
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 - 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.
Stock Symbol:
SAGE
- Website
- https://www.sagerx.com/
- Phone
- 617-299-8380
- Location
-
215 First Street
Cambridge
MA
02142
United States
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