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Senior Quality Assurance Manager
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Manager, GCP Quality Assurance - Lexington, United States - Wave Life Sciences
Description
Job DescriptionWave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health.
Our RNA medicines platform, PRISM, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders.
Our toolkit of RNA-targeting modalities includes editing, splicing, RNA interference and antisense silencing, providing us with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology.
Our diversified pipeline includes clinical programs in Duchenne muscular dystrophy, Alpha-1 antitrypsin deficiency and Huntington's disease, as well as a preclinical program in obesity.
Driven by the calling to "Reimagine Possible", we are leading the charge toward a world in which human potential is no longer hindered by the burden of disease.
Description:
The Manager, GCP Quality Assurance will provide expertise and guidance on Good Clinical Practice (GCP), applicable regulations to clinical and nonclinical development teams to proactively identify compliance issues/risks and recommend mitigation.
They will work with internal clinical functions and external parties including consultants, contract auditors, CROs and investigator sites to promote a high level of quality and consistency across and within programs; develop the risk-based audit and compliance strategy for all programs.
Will manage domestic and international risk-based audits of investigator sites, study documents, databases, vendors, partners, and internal systems in compliance with GCP, and company policies and procedures; assess impact of audit.
They will support a culture of sustainable compliance; assist project teams in implementing corrective and preventive actions; and enable teams to be inspection ready.
Experience:
Bachelor's degree in a scientific discipline is required. Advanced degree preferred.
7+ years of clinical trial experience in a pharmaceutical, biotech, hospital setting, or a CRO is required with at least 5 years managing clinical trials.
Extensive knowledge and/or awareness of ICH GCP and applicable global regulations and guidance for clinical developmentResponsibilities:Provide expertise in GCP, compliance interpretation, consultation, training, and recommendations to clinical development functions and program teams Lead investigations into significant quality issues, scientific misconduct and suspected serious breach of GCP or GLP; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities, as appropriate.
Manage deviations and CAPAs through completion Identify and mitigate GCP activities and process improvement initiatives as requested by management Work closely with Quality Assurance Head to ensure alignment and compliance with Wave Quality Systems Provide risk identification/mitigation support for potential or identified quality issues Appropriately escalate any quality/compliance issues to relevant leadership Perform a quality assurance review of documents and data intended for regulatory submission Perform quality assurance and GCP compliance review of various clinical study documentation such as study protocols, ICFs, monitoring plans, clinical study reports, etc.
Create, revise and review of GCP systems related SOPs to assess their adherence to applicable regulatory standards and corporate goals.
Create and give training as needed Assist in the development, tracking, and reporting of quality metrics Participate in GCP health authority inspections as required Participate in due diligence activities and process improvement initiatives as requested by management Maintain compliance with all company policies and procedures Perform and participate in audits Perform related duties as assigned by supervisorKey Skills:Advanced knowledge in the management of quality events and GCP deviations, inclusive of conducting robust root cause analysis and developing CAPA plans that mitigate risks to the company, to safety and data integrity Proven experience supporting clinical study protocol, Informed Consent, Clinical Study Report preferred Experience with computer system validation (CSV) is a plus Ability to work independently and in a team environment, seeking resources as needed Ability to assess sophisticated issues, break down the components, proposing viable solutions Excellent written, verbal and presentation skills for effectively interfacing with partner organizations, collaborators, and customersWave Life Sciences provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics.
In addition to federal law requirements, Wave Life Sciences complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
Wave Life Sciences expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status.
Improper interference with the ability of Wave Life Sciences' employees to perform their job duties may result in discipline up to and including discharge.
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 Wave Life Sciences.
