Associate Director, Quality Assurance GCP/GLP
Company: Sage Therapeutics
Posted on: July 3, 2020
General Scope and Summary
SAGE Therapeutics is searching for a creative, resourceful,integrative thinker to contribute to Quality activities in supportof research projects across multiple therapeutic areas with a focuson GVP and GCP compliance and audit activities.
Roles and Responsibilities
- Assess GVP and GCP compliance risk areas (internal andexternal) and develop and implement risk mitigation measures.
- Provide guidance, interpretation and information onregulations, standards and quality systems to Sage functionalareas; particularly the Drug Safety and Pharmacovigilancegroup
- Plan and lead GVP and GCP audits (international and domestic),including clinical investigator site, contract clinicallaboratories, CROs, and marketing partners to determine compliancestatus and identify compliance risks.
- Develop and measure quality metrics to drive consistent qualitystandards relating to GVP and GCP activities.
- Participate in cross functional Clinical Study Team meetingsand provide guidance as needed.
- Supporting inspection readiness activities for developmentcompounds.
- Ensure compliance with company's procedures and regulatoryrequirements.
- Participate in the evaluation and selection of CROs and otherclinical, pharmacovigilance service providers.
- Develop and implement standards, policies and procedures forregulatory compliance.
Experience, Education and Specialized Knowledge and Skills
Must thrive working in a fast-paced, innovative environment whileremaining flexible, proactive, resourceful and efficient. Excellentinterpersonal skills, ability to develop important relationshipswith key stakeholders, good conflict management and negotiationskills, ability to analyze complex issues to develop relevant andrealistic plans, and program recommendations. Demonstrated abilityto translate strategy into action; excellent analytical skills andan ability to communicate complex issues in a simple way and toorchestrate plans to resolve issues and mitigate risks.
- B.S. Degree with 10+ years related experience in thepharmaceutical or biopharmaceutical industry.
- Demonstrated expiring in Quality Systems related to GVP, GCP,and GLP.
- Strong analytic skills with practical knowledge of how toidentify key performance quality metrics to set targets formaintaining a state of compliance while identifying areas forimprovement.
- Extensive experience auditing clinical CROs, clinical sites andinvestigator sites.
- Understanding and application of domestic and internationalregulatory requirements.
- Outstanding communication skills (interpersonal, verbal andwritten).
- Strong leadership and management skills.
- Excellent teamwork and collaboration skills.
- Embrace our core values: Put People First, Do Big, BeAccountable, Grow through Learning and Change, and Work Fun.
- Excitement about the vision and mission of Sage.
Employment Type:EmployeeNumber of Openings:1JobID:R000460#Biotechnology #Careers #ThisIsSageAll qualifiedapplicants will receive consideration for employment withoutdiscrimination on the basis of race, color, religion, sex, sexualorientation, gender identity, national origin, protected veteranstatus, 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. Toprotect the interests of all parties, and given the large volume ofinquiries received from third-party placement agencies, we are notable to respond to all agency inquiries. We do not acceptunsolicited resumes from any source other than directly fromcandidates for current or future positions. Submission ofunsolicited resumes in advance of a signed agreement between ourcompany and a placement agency does not create an impliedobligation and, if an unsolicited candidate represented by aplacement agency is hired, we are not obligated to pay a fee. Onlyapproved recruitment firms will be allowed to provide services toSage Therapeutics, Inc.
Keywords: Sage Therapeutics, Cambridge , Associate Director, Quality Assurance GCP/GLP, Executive , Cambridge, Massachusetts
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